Internet-enhanced management of fibromyalgia: A randomized controlled trial
Open accessAbstract
Both pharmacological and non-pharmacological interventions have demonstrated efficacy in the management of fibromyalgia (FM). Non-pharmacological interventions however are far less likely to be used in clinical settings, in part due to limited access. This manuscript presents the findings of a randomized controlled trail of an Internet-based exercise and behavioral self-management program for FM designed for use in the context of a routine clinical care. 118 individuals with FM were randomly assigned to either (a) standard care or (b) standard care plus access to a Web-Enhanced Behavioral Self-Management program (WEB-SM) grounded in cognitive and behavioral pain management principles. Individuals were assessed at baseline and again at 6 months for primary endpoints: reduction of pain and an improvement in physical functioning. Secondary outcomes included fatigue, sleep, anxiety and depressive symptoms, and a patient global impression of improvement. Individuals assigned to the WEB-SM condition reported significantly greater improvement in pain, physical functioning, and overall global improvement. Exercise and relaxation techniques were the most commonly used skills throughout the 6 month period. A no-contact, Internet-based, self-management intervention demonstrated efficacy on key outcomes for FM. While not everyone is expected to benefit from this approach, this study demonstrated that non-pharmacological interventions can be efficiently integrated into routine clinical practice with positive outcomes.
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Written from the paper’s full text.
TL;DR
In a 6-month intent-to-treat randomized controlled trial, adding a no-contact Internet behavioral self-management program to standard care significantly improved pain and physical functioning in adults with fibromyalgia compared with standard care alone. Secondary sleep, fatigue, and mood outcomes did not differ, but patient global impression of change favored the web-enhanced group.
Key findings
- Among 118 randomized participants (59 per arm), WEB-SM improved average pain versus standard care (F(1,115)=5.67, p<.01); 30% pain responders were 29% in WEB-SM vs 8% in standard care (p<.008), with NNT=5.
- Physical functional status improved in WEB-SM versus standard care (F(1,115)=5.08, p<.03); 0.50 SD responders were 31% vs 6% (p<.002), with NNT=5.
- Sleep, fatigue, depression, and anxiety did not show significant group differences. PGIC improvement was reported by 57% of WEB-SM participants vs 21% of standard care participants (n=35 vs n=33; p<.003).
- Adherence: 89%–94% of WEB-SM participants used at least one module monthly, averaging 4 skills at a time; functional responders used exercise, pleasant activity, and problem solving more than non-responders (p<.03, p<.02, p<.03), while no clear skill pattern was tied to pain response.
Methods
- Six-month RCT at Avera Research Institute in Sioux Falls, South Dakota, in a mostly rural five-state catchment; 118 adults meeting ACR fibromyalgia criteria were randomized 1:1 to standard care or standard care plus WEB-SM, a 13-module website with no additional coaching or professional contact.
- Primary outcomes were SF-36 Physical Functioning and Brief Pain Inventory Severity; secondary outcomes included Multidimensional Fatigue Inventory, MOS Sleep Scale, CES-D, STPI anxiety, and PGIC.
- Intent-to-treat analysis used baseline observation carried forward for missing endpoint values; baseline-adjusted ANCOVA tested group differences, with Fisher’s exact tests for responder, adherence, manipulation-check, and satisfaction comparisons. Sample was 95% female, mean age 50 years (SD=11.5), 97% Caucasian, 79% married, mean FM duration 9.4 years (SD=6.5), mean BMI 28.7 (SD=5.3); attrition was 10.2%.
Limitations
- The authors state that the standard care control limits attribution of outcomes exclusively to module content rather than nonspecific factors such as increased Internet use or self-focus; they also note no passive web engagement tracking, no power for secondary outcomes, and that PGIC was added mid-trial and available for only about half the sample.
- The authors state that a no-contact intervention may not be sufficiently intense or structured for all patients with fibromyalgia, and that fatigue, sleep, and mood were not impacted, possibly requiring more specialized content.
- Evident from the text: the sample was predominantly female, Caucasian, married, and recruited through a rural telemedicine network, which may limit generalizability; outcomes were self-reported, and 10.2% attrition was handled with baseline observation carried forward.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 42 cited sources checked · 0 supported · 0 flagged
- Findingreasoning
No specific set of modules was uniquely tied to the pain responders.
“however no specific set of modules were uniquely tied to the pain responders.”
Quote in the paperSubstantial claim - Findingown data
Using a responder criterion of 0.50 standard deviation improvement, the WEB-SM group had more individuals improving (31% vs 6%, p<.002).
“Using a responder criterion of 0.50 standard deviation improvement, the WEB-SM group again demonstrated more individuals improving (WEB-SM: 31% vs. standard care: 6%; p<.002, Fisher’s exact test).”
Quote in the paperSubstantial claim - Findingown data
Improvement in overall well-being was observed more frequently in the web-based group than in the standard care control.
“Improvement in overall well-being was also observed more frequently in the web-based group than in the standard care control.”
Quote in the paperSubstantial claim - Findingown data
Among those with PGIC data, 57% of WEB-SM recipients versus 21% of standard care recipients reported at least minimal improvement (p<.003).
“Although available for only half of the sample (i.e., standard care, n=33, WEB-SM, n=35) there was a statistically significant difference in the numbers of individuals reporting at least minimal improvement (i.e., 57% of the WEB-SM recipients) but only 21% of standard care (p<.003, Fisher’s exact test).”
Quote in the paperSubstantial claim - Findingown data
The standard care control group demonstrated no appreciable effect on patients' pain or function.
“In fact, the standard care control group demonstrated no appreciable effect on patient’s pain or function as can be seen in Table 3.”
Quote in the paperSubstantial claim
- Findingown data
The WEB-SM group demonstrated statistically significant improvement in physical functional status compared to standard care only (F(1,115)=5.08, p<.03).
“The WEB-SM group demonstrated statistically significant improvement in physical functional status compared to standard care only (F(1,115)=5.08, p<.03).”
Quote in the paperSubstantial claim - Findingown data
The number needed to treat for the 30% pain responder rate was 5.
“The number needed to treat (NNT) for the 30% responder rate was 5.”
Quote in the paperSubstantial claim - Findingown data
The treatment effect size for pain was 0.64 (Cohen's d=.64, calculated using change scores and pooled change score SD).
“With treatment effect sizes being 0.64 for pain (i.e., Cohen’s d=.64 , calculated using change scores and pooled change score (SD))”
Quote in the paperSubstantial claim - Findingown data
The WEB-SM group reported a greater increase in self-management skill use (77% vs 33%, p<.001).
“The WEB-SM group also reported a greater increase in self-management skill use (WEB-SM: 77% vs. standard care: 33%; p<.001, Fisher’s exact test)”
Quote in the paperNot a substantial claim - Findingown data
86% of the WEB-SM group versus 42% of the standard care group answered affirmatively to experiencing an increase in self-management skills (p<.001).
“In response to the question, “Have you experienced an increase in self-management skills as a result of being in this study?”, 86% of the WEB-SM group answered affirmatively compared to only 42% of the standard care group (Fisher’s exact test, p<.001).”
Quote in the paperSubstantial claim - Findingown data
Only the use of exercise, pleasant activity scheduling, and problem solving uniquely differentiated responders from non-responders with regards to improvements in functional status.
“only the use of exercise, pleasant activity scheduling, and problem solving uniquely differentiated responders from non-responders with regards to improvements in functional status.”
Quote in the paperSubstantial claim - Findingown data
Summary measures of sleep, fatigue, and mood failed to demonstrate significant differences between groups.
“Summary measures of sleep, fatigue, and mood (i.e., depression and anxiety) failed to demonstrate significant differences between groups.”
Quote in the paperNot a substantial claim - Findingown data
The WEB-SM group demonstrated significantly improved average pain intensity compared to the standard care only group (F(1,115)=5.67, p<.01).
“The group of individuals with FM receiving WEB-SM in addition to their standard care demonstrated significantly improved average pain intensity when compared to those receiving standard care only (F(1,115)=5.67, p<.01).”
Quote in the paperSubstantial claim - Findingown data
Significant reductions in pain were associated with the WEB-SM intervention as compared to standard care.
“Significant reductions in pain were also associated with the WEB-SM intervention as compared to standard care”
Quote in the paperSubstantial claim - Findingown data
Problem solving and reframing were the least favored skills in the WEB-SM group.
“The least favored skills were problem solving and reframing.”
Quote in the paperNot a substantial claim - Findingown data
Exercise was used most by WEB-SM study participants, with 64-70% of participants using it over all 6 months of the study.
“exercise, a skill targeting both pain and function, was used most by study participants (i.e., 64–70% of participants over all 6 months of the study).”
Quote in the paperNot a substantial claim - Findingown data
Functional status responders demonstrated significantly greater use of the exercise, pleasant activity, and problem solving modules than did non-responders.
“Functional status responders demonstrated significantly greater use of the exercise, pleasant activity, and problem solving modules than did non-responders (t(48)=2.19, p<.03; t(45)=2.27, p<.02; t(33)=2.26, p<.03) respectively.”
Quote in the paperNot a substantial claim - Findingown data
Sustained improvements in pain and physical functional status were demonstrated in a sample of individuals with fibromyalgia using an Internet-based self-management program.
“In summary, sustained improvements in pain and physical functional status were demonstrated in a sample of individuals with FM using an Internet-based self-management program.”
Quote in the paperSubstantial claim - Findingown data
No clear relationships were identified between adherence to specific skill use and responder status for pain reductions.
“No clear relationships were identified between adherence to specific skill use and responder status for pain reductions.”
Quote in the paperNot a substantial claim - Findingown data
The proportion of patients reporting a 30% decrease in mean pain score from baseline to endpoint was significantly greater in the WEB-SM group (29% vs 8%, p<.008).
“Additionally, the proportion of patients reporting a 30% decrease in mean pain score from baseline to endpoint (i.e., pain responders), was significantly greater in the WEB-SM group (WEB-SM: 29% vs. standard care: 8%; p<.008, Fisher’s exact test).”
Quote in the paperSubstantial claim - Findingown data
The number needed to treat for clinically meaningful improvement in physical functioning was 5.
“The number needed to treat (NNT) in order to achieve a clinically meaningful improvement in physical functioning was again 5.”
Quote in the paperSubstantial claim - Findingown data
The treatment effect size for function was 0.38 (Cohen's d=.38).
“and 0.38 for function (i.e., Cohen’s d=.38 )”
Quote in the paperSubstantial claim - Findingown data
On average, 4 skills were used by each participant in the WEB-SM group over the course of the 6 month study.
“As we reported, on average, 4 skills were used by each participant in the WEB-SM group over the course of the 6 month study”
Quote in the paperSubstantial claim - Findingown data
The WEB-SM group reported actual changes in behavior resulting in improvement (76% vs 29%, p<.001).
“and reported actual changes in behavior resulting in improvement (WEB-SM: 76% vs. standard care: 29%; p<.001, Fisher’s exact test).”
Quote in the paperNot a substantial claim - Findingown data
The relaxation response was the second most highly utilized skill in the WEB-SM group.
“The relaxation response, a skill aimed primarily at pain, was the second most highly utilized skill.”
Quote in the paperNot a substantial claim - Findingown data
Greater improvements in physical functional status were significantly associated with problem solving, a cognitively-based skill.
“Greater improvements in physical functional status was significantly associated with one of the cognitively-based skills (i.e., problem solving).”
Quote in the paperSubstantial claim - Study design and conductcitation
The use of the SF-36 Physical Functioning single subscale is supported by recent literature as being a better measure of change for clinical trials than composite summary scores.
“The use of this single subscale of the SF-36 is supported by recent literature as being a better measure of change for clinical trials than the composite summary scores that can be derived from this same measure [30; 57].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [30] Hann M Reeves D The SF-36 scales are not accurately summarised by independent physical and mental component scores Qual Life Res 2008 17 3 413 423 18259888 source
Not checked in the free run.
- cites [57] Strand V Crawford B Singh J Choy E Smolen JS Khanna D Use of “spydergrams” to present and interpret SF-36 health-related quality of life data across rheumatic diseases Ann Rheum Dis 2009 68 12 1800 1804 19910301 PMC2950749 source
Not checked in the free run.
- Premisecitation
Pharmacological agents, particularly dual reuptake inhibitors and anticonvulsants, possess the strongest evidence for efficacy in fibromyalgia.
“Pharmacological agents, particularly those classified as dual reuptake inhibitors and anticonvulsants possess the strongest evidence for efficacy in FM [27].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [27] Goldenberg DL Burckhardt C Crofford L Management of fibromyalgia syndrome JAMA 2004 292 19 2388 2395 15547167 source
Not checked in the free run.
- Premisecitation
Evidence supporting the efficacy of non-pharmacological treatment in fibromyalgia is strong.
“Evidence supporting the efficacy of non-pharmacological treatment in FM is strong (e.g., [67; 61; 11; 12; 15; 62])”
Quote in the paperSubstantial claim0 of 6 sources checked- cites [67] Williams DA Psychological and behavioural therapies in fibromyalgia and related syndromes BestPractResClinRheumatol 2003 17 4 649 665 12849717 source
Not checked in the free run.
- cites [61] Thieme K Flor H Turk DC Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments Arthritis Res Ther 2006 8 4 R121 16859516 PMC1779398 source
Not checked in the free run.
- cites [11] Brosseau L Wells GA Tugwell P Egan M Wilson KG Dubouloz CJ Casimiro L Robinson VA McGowan J Busch A Poitras S Moldofsky H Harth M Finestone HM Nielson W Haines-Wangda A Russell-Doreleyers M Lambert K Marshall AD Veilleux L Ottawa Panel evidence-based clinical practice guidelines for aerobic fitness exercises in the management of fibromyalgia: part 1 PhysTher 2008 88 7 857 871 18497301 source
Not checked in the free run.
- cites [12] Brosseau L Wells GA Tugwell P Egan M Wilson KG Dubouloz CJ Casimiro L Robinson VA McGowan J Busch A Poitras S Moldofsky H Harth M Finestone HM Nielson W Haines-Wangda A Russell-Doreleyers M Lambert K Marshall AD Veilleux L Ottawa Panel evidence-based clinical practice guidelines for strengthening exercises in the management of fibromyalgia: part 2 PhysTher 2008 88 7 873 886 18497302 source
Not checked in the free run.
- cites [15] Busch AJ Thille P Barber KA Schachter CL Bidonde J Collacott BK Best practice: E-Model--prescribing physical activity and exercise for individuals with fibromyalgia PhysiotherTheoryPract 2008 24 3 151 166 18569853 source
Not checked in the free run.
- cites [62] Thieme K Gracely RH Are psychological treatments effective for fibromyalgia pain? Curr Rheumatol Rep 2009 11 6 443 450 19922735 source
Not checked in the free run.
- Premisecitation
Only about 40% of patients taking dual reuptake inhibitors or anticonvulsants experience a clinically important reduction in pain.
“Despite wide use however, only about 40% of patients taking these medications experiences a clinically important reduction in pain [4].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [4] Arnold LM Biology and therapy of fibromyalgia. New therapies in fibromyalgia Arthritis Res Ther 2006 8 4 212 16762044 PMC1779399 source
Not checked in the free run.
- Premisecitation
Efficacious face-to-face interventions adapted for the Internet frequently retain effect sizes rivaling those of traditionally delivered interventions.
“Such adapted therapies frequently retain effect-sizes rivaling those of the more traditionally delivered interventions [41; 28; 19]”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [41] Murray E Burns J See TS Lai R Nazareth I Interactive Health Communication Applications for people with chronic disease Cochrane Database Syst Rev 2005 4 CD004274 16235356 PMC13184810 source
Not checked in the free run.
- cites [28] Griffiths F Lindenmeyer A Powell J Lowe P Thorogood M Why are health care interventions delivered over the internet? A systematic review of the published literature J Med Internet Res 2006 8 2 e10 16867965 PMC1550698 source
Not checked in the free run.
- cites [19] Cuijpers P van Straten A Andersson G Internet-administered cognitive behavior therapy for health problems: a systematic review J Behav Med 2008 31 2 169 177 18165893 PMC2346512 source
Not checked in the free run.
- Interpretationown data
The magnitude of the therapeutic impact of this non-pharmacological intervention rivals or surpasses those for current pharmacological interventions available in the U.S.
“the magnitude of the therapeutic impact of this non-pharmacological intervention rivals or surpasses those for current pharmacological interventions available in the U.S.”
Quote in the paperSubstantial claim - Study design and conductreasoning
The current design is limited if one wishes to attribute the outcomes exclusively to the specific content of the modules and not to other potential non-specific factors.
“It should be noted however that the current design is limited if one wishes to attribute the outcomes exclusively to the specific content of the modules and not to other potential non-specific factors such as derivatives of increased internet use, or non-specific derivatives of having viewed the modules (e.g., increased self-focus, changes in daily routine etc).”
Quote in the paperNot a substantial claim - Interpretationreasoning
Using outcome measures consistent with industry drug-efficacy assessments allows for more meaningful comparisons between pharmacological and non-pharmacological approaches to fibromyalgia management.
“This methodology allows for more meaningful comparisons between pharmacological and non-pharmacological approaches to FM management.”
Quote in the paperSubstantial claim - Interpretationreasoning
A tally of web pages viewed would not be a relevant metric of adherence for this study.
“Thus a tally of web pages viewed would not be a relevant metric of adherence for this study.”
Quote in the paperSubstantial claim - Interpretationown data
Despite the availability of all nine modules, exercise, pleasant activity scheduling, and problem solving were the most consistently associated with functional status benefits when delivered to patients in this manner.
“This suggests that despite the availability of all nine modules these three modules were the most consistently associated with functional status benefits when delivered to patients in this manner.”
Quote in the paperSubstantial claim - Interpretationown data
Participants favored behaviorally-based skills over more cognitively-oriented approaches when delivered in this format.
“Overall it appeared that participants favored the behaviorally-based skills over the more cognitively-oriented approaches when delivered in this format.”
Quote in the paperNot a substantial claim - Study design and conductcitation
The study was powered to detect a treatment effect on physical functioning.
“The current study was powered in order to detect a treatment effect on physical functioning, the target of a previous randomized controlled clinical trial of face-to-face CBT in FM upon which the content of this intervention was based [68].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [68] Williams DA Cary MA Groner KH Chaplin W Glazer LJ Rodriguez AM Clauw DJ Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention JRheumatol 2002 29 6 1280 1286 12064847
Not checked in the free run.
- Premisecitation
Multiple theoretical models support traditional face-to-face cognitive-behavioral therapy.
“Multiple theoretical models support traditional face-to-face CBT including the theory of reasoned action [24], the theory of planned behavior [2], social-cognitive theory [6], control theory [16], the health beliefs model [33] operant conditioning [53] and the biopsychosocial model of pain [64].”
Quote in the paperSubstantial claim0 of 7 sources checked- cites [24] Fishbein M Ajzen I Belief, attitude, intention and behavior: An introduction to theory and research Reading, MA Addison Wesley 1975
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [2] Ajzen I The theory of planned behavior Organizational Behavior and Human Decision Processes 1991 50 179 211 source
Not checked in the free run.
- cites [6] Bandura A Self-efficacy: The exercise of control New York Freeman 1997
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- cites [16] Carver CS Scheier MF Control-Theory - a Useful Conceptual-Framework for Personality-Social, Clinical, and Health Psychology Psychological Bulletin 1982 92 1 111 135 7134324 source
Not checked in the free run.
- cites [33] Janz NK Becker MH The Health Belief Model: a decade later Health Educ Q 1984 11 1 1 47 6392204 source
Not checked in the free run.
- cites [53] Skinner BF The operant side of behavior therapy J Behav Ther Exp Psychiatry 1988 19 3 171 179 3069874 source
Not checked in the free run.
- cites [64] Turk DC Meichenbaum D Genest M Pain and Behavioral Medicine: A Cognitive-Behavioral Perspective New York The Guilford Press 1983
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
- Study design and conductown data
Adherence to module use in general was good, with 3-4 modules used each month on average.
“While adherence to module use in general was good (e.g., 3–4 modules used each month on average)”
Quote in the paperNot a substantial claim - Interpretationreasoning
About 1 in 5 patients would be expected to receive this level of benefit from this web-based intervention between baseline and 6 months.
“Thus about 1 in 5 patients would be expected to receive this level of benefit from this web-based intervention between baseline and 6 months.”
Quote in the paperSubstantial claim - Study design and conductnone given
The study used outcome measures consistent with those used in industry for the assessment of drug efficacy in fibromyalgia.
“A strength of the current study was its use of outcome measures that were consistent with those being used in industry for the assessment of drug efficacy in FM.”
Quote in the paperSubstantial claim - Study design and conductown data
Monthly monitoring of behavioral skill usage revealed at least 1 module being used each month by 89%-94% of the WEB-SM sample.
“For the WEB-SM group, monthly monitoring of behavioral skill usage revealed at least 1 module being used each month by 89%–94% of the sample.”
Quote in the paperNot a substantial claim - Study design and conductreasoning
The study was not powered to detect differences in the secondary outcomes.
“This study was not powered to detect differences in the secondary outcomes.”
Quote in the paperSubstantial claim - Interpretationreasoning
No one module or set of modules played the leading role for the majority of pain responders when delivered in this manner.
“Thus, no one module or set of modules played the leading role for the majority of pain responders when delivered in this manner.”
Quote in the paperSubstantial claim - Interpretationcitation
A no-contact intervention holds the advantage of being broadly available at relatively low cost once development costs are considered.
“Such a no-contact intervention holds the advantage of being broadly available at relatively low cost once development costs are considered [60].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [60] Tate DF Finkelstein EA Khavjou O Gustafson A Cost effectiveness of internet interventions: review and recommendations Ann Behav Med 2009 38 1 40 45 19834778 PMC2772952
Not checked in the free run.
- Study design and conductreasoning
A potential limitation of this study was the choice not to passively monitor actual web engagement.
“A potential limitation of this study was our choice not to passively monitor actual web engagement (e.g., electronic tracking of webpage viewing or viewing duration).”
Quote in the paperNot a substantial claim - Interpretationown data
Given the magnitude of the effect sizes found in the WEB-SM group compared to standard care, such online programs have potential as a front line approach to the management of fibromyalgia.
“Given the magnitude of the effect sizes found in the WEB-SM group compared to standard care, such online programs have potential as a front line approach to the management of FM.”
Quote in the paperNot a substantial claim
- May combine two claims. 14
- Classified as probably not a substantial claim. 22
May combine two claims.
FindingreasoningFatigue, sleep and mood domains were not impacted by this Internet intervention.
“Fatigue, sleep and mood domains (e.g., depressive and anxiety symptoms) were not impacted by this Internet intervention.”
Quote in the paperSubstantial claimMay combine two claims.
Findingnone givenUnlike pain and functional deficits, which were common to all participants, not all participants possessed difficulties with each of the secondary outcome measures.
“Relatedly, unlike pain and functional deficits which were common to all participants, not all participants possessed difficulties with each of the secondary outcome measures.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenGroup assignment was given to both the participant and selected study staff only after completion of the baseline assessments.
“group assignment was given to both the participant and selected study staff only after completion of the baseline assessments.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductreasoningAn intent-to-treat approach was used, and all 118 randomized individuals were included in the analyses.
“An intent-to-treat approach was used in this study; therefore all 118 individuals who were randomized at baseline were included in the subsequent analyses.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductown dataParticipants were randomly assigned to treatment condition using a 1:1 ratio.
“Participants were randomly assigned to a treatment condition using a 1:1 ratio.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitationThe SF-36 is a widely used generic measure of self-reported functional status that can be compared across differing disease states.
“The SF-36 is a widely used measure of self-reported functional status and was developed as a generic measure capable of being used and compared across differing disease states.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [65] Ware JE Snow K Kosinski M SF-36r Health Survey: Manual and Interpretation Guide Lincoln, RI QualityMetric, Inc 1993 2000
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningAllocation concealment was utilized to prevent selection bias.
“Allocation concealment was utilized to prevent selection bias”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe study had an attrition rate of 10.2%.
“The attrition rate for the study was 10.2%.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationFor many patients, optimal care may require the combination of pharmacological and non-pharmacological interventions such as cognitive-behavioral therapy and exercise.
“For many patients, optimal care may require the combination of pharmacological and non-pharmacological interventions such as cognitive-behavioral therapy (CBT) and exercise [27].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [27] Goldenberg DL Burckhardt C Crofford L Management of fibromyalgia syndrome JAMA 2004 292 19 2388 2395 15547167 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenStudy personnel assigned to assist participants in the clinic setting were blinded to participants' treatment assignment.
“Study personnel assigned to assist participants in the clinic setting were blinded to participants’ treatment assignment.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationInternet-adapted therapies have added benefits of convenience, privacy, and the ability to provide full-spectrum care to patients in remote areas.
“with the added benefits of convenience, privacy, and providing clinicians with the ability to provide a full-spectrum of care to patients even in remote areas [29; 48].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [29] Griffiths KM Christensen H Internet-based mental health programs: a powerful tool in the rural medical kit Aust J Rural Health 2007 15 2 81 87 17441815 source
Not checked in the free run.
- cites [48] Ritterband LM Thorndike FP Cox DJ Kovatchev BP Gonder-Frederick LA A behavior change model for internet interventions Ann Behav Med 2009 38 1 18 27 19802647 PMC2878721 source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationSeveral cognitive-behavioral oriented Internet interventions have been studied for use with chronic pain.
“Several cognitive-behavioral oriented Internet interventions have been studied for use with chronic pain (e.g., [14; 10; 46])”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [14] Buhrman M Faltenhag S Strom L Andersson G Controlled trial of Internet-based treatment with telephone support for chronic back pain Pain 2004 111 3 368 377 15363881 source
Not checked in the free run.
- cites [10] Brattberg G Internet-based rehabilitation for individuals with chronic pain and burnout: a randomized trial Int J Rehabil Res 2006 29 3 221 227 16900043 source
Not checked in the free run.
- cites [46] Palermo TM Wilson AC Peters M Lewandowski A Somhegyi H Randomized controlled trial of an Internet-delivered family cognitive-behavioral therapy intervention for children and adolescents with chronic pain Pain 2009 146 1–2 205 213 19695776 PMC2760656 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationA face-to-face study demonstrated greater improvements in pain and functional status associated with interventions emphasizing behavioral over cognitive skills.
“This finding is consistent with a face-to-face study demonstrating greater improvements in pain and functional status being associated with interventions emphasizing behavioral over cognitive skills [61].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [61] Thieme K Flor H Turk DC Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments Arthritis Res Ther 2006 8 4 R121 16859516 PMC1779398 source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductreasoningAs a compromise, the study selected against passive monitoring in favor of homework monitoring, an older more traditional methodology for measuring adherence to behaviorally oriented treatments.
“As a compromise we selected against the use of passive monitoring in favor of an older more traditional methodology for measuring adherence to behaviorally oriented treatments - homework monitoring [1].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1] Abraham C Michie S A taxonomy of behavior change techniques used in interventions Health Psychol 2008 27 3 379 387 18624603 source
Not checked in the free run.
Classified as probably not a substantial claim. May combine two claims.
PremisecitationCBT is efficacious in insomnia and mental health conditions.
“At first this might be surprising given the efficacy of CBT in insomnia and mental health conditions [22; 58].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [22] Edinger JD Wohlgemuth WK Krystal AD Rice JR Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial ArchInternMed 2005 165 21 2527 2535 16314551 source
Not checked in the free run.
- cites [58] Stuhlmiller C Tolchard B Computer-assisted CBT for depression & anxiety: increasing accessibility to evidence-based mental health treatment J Psychosoc Nurs Ment Health Serv 2009 47 7 32 39 19678477 source
Not checked in the free run.
May combine two claims.
InterpretationcitationPatients benefit as they can access self-management information in private and at their own convenience over the long term, an important consideration for a chronic condition.
“Patients also benefit as they can access self-management information in private and at their own convince over the long term–which is an important consideration when managing a condition that by definition is chronic [48].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [48] Ritterband LM Thorndike FP Cox DJ Kovatchev BP Gonder-Frederick LA A behavior change model for internet interventions Ann Behav Med 2009 38 1 18 27 19802647 PMC2878721 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationThe Brief Pain Inventory is a multidimensional pain measure validated for use in chronic, nonmalignant pain.
“The BPI is a multidimensional pain measure validated for use in chronic, nonmalignant pain.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [59] Tan G Jensen MP Thornby JI Shanti BF Validation of the Brief Pain Inventory for chronic nonmalignant pain J Pain 2004 5 2 133 137 15042521 source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningSuch a program offers clinicians, particularly rural clinicians, high quality information for their patients without the requirement of finding a qualified local therapist.
“Further, such a program offers clinicians (particularly rural clinicians) high quality information for their patients without the requirement of finding a qualified local therapist (which in some settings, is unattainable).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductreasoningThe PGIC measure was added to the protocol mid-way through the trial, so data are available for roughly half of the subjects in each arm.
“Both arms of the study initiated the use of this measure concurrently and thus these data are available for roughly half of the subjects in each arm of the study.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThe study evaluated a purely web-based, no-contact intervention for use in the context of routine care.
“Another strength of the current study was the objective of evaluating a purely web-based, no-contact intervention for use in the context of routine care.”
Quote in the paperSubstantial claimMay combine two claims.
Study design and conductown dataThe WEB-SM group differed from the standard care arm based on the content participants perceived themselves to have received, supporting the internal validity of the study.
“In support of the internal validity of the study, the the WEB-SM group did in fact differ from the standard care arm based on the content participants perceived themselves to have received.”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationown dataThis six-month randomized controlled intent-to-treat trial demonstrated that a no-contact educationally-based Internet self-management program significantly reduced pain and improved physical functioning in individuals with fibromyalgia compared to a standard care control group.
“This six-month, randomized controlled intent-to-treat trial, demonstrated that a no-contact educationally-based Internet self-management program significantly reduced pain and improved physical functioning in individuals with FM compared to a standard care control group.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
InterpretationcitationThese findings are consistent with previous studies demonstrating benefits of cognitive and behaviorally oriented approaches to managing fibromyalgia delivered in traditional face-to-face formats.
“These findings are consistent with previous studies demonstrating the benefits of cognitive and behaviorally oriented approaches to managing FM delivered in traditional face-to-face formats [40; 68; 67; 61].”
Quote in the paperNot a substantial claim0 of 4 sources checked- cites [40] Morley S Eccleston C Williams A Systematic review and meta-analysis of randomized controlled trials of cognitive behaviour therapy and behaviour therapy for chronic pain in adults, excluding headache Pain 1999 80 1–2 1 13 10204712 source
Not checked in the free run.
- cites [68] Williams DA Cary MA Groner KH Chaplin W Glazer LJ Rodriguez AM Clauw DJ Improving physical functional status in patients with fibromyalgia: a brief cognitive behavioral intervention JRheumatol 2002 29 6 1280 1286 12064847
Not checked in the free run.
- cites [67] Williams DA Psychological and behavioural therapies in fibromyalgia and related syndromes BestPractResClinRheumatol 2003 17 4 649 665 12849717 source
Not checked in the free run.
- cites [61] Thieme K Flor H Turk DC Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments Arthritis Res Ther 2006 8 4 R121 16859516 PMC1779398 source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable).
PremisecitationFrom the perspective of translational clinical research, using a standard care control condition represents a preferred methodology for a study of this nature.
“From the perspective of translational clinical research, our use of a standard care control condition represents a preferred methodology for a study of this nature [20].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [20] Danaher BG Seeley JR Methodological issues in research on web-based behavioral interventions Ann Behav Med 2009 38 1 28 39 19806416 PMC3846298 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenA conservative approach to imputation, baseline observation carried forward, was used in intent-to-treat analyses for missing endpoint values due to early termination.
“A conservative approach to imputation (i.e., baseline observation carried forward (BOCF)) was used in ITT analyses for missing endpoint values due to early termination.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisereasoningEach of the 13 modules contained in the website possessed theoretical grounding and empirical support from traditional face-to-face studies.
“Thus each of the 13 modules contained in the website possessed theoretical grounding and possessed empirical support from traditional face-to-face studies justifying their inclusion in this program (see Table 1).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Table 1
Not checked in the free run.
May combine two claims.
Study design and conductown dataThe two groups did not differ from one another with respect to any sample characteristics or on baseline outcome measures, supporting the success of randomization.
“The two groups did not differ from one another with respect to any of the sample characteristics or on baseline outcome measures (see Table 3) thus supporting the success of randomization.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Interpretationnone givenA no-contact intervention may not be sufficiently intense or structured to address the needs, complex sets of symptoms, and preferences of all patients.
“A no-contact intervention may not be sufficiently intense or structured to address the needs, complex sets of symptoms, and preferences of all patients.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationown dataThe average use of 4 skills supports the accessibility, relevance, and durability of the information contained within the modules for this patient population.
“supporting both the accessibility, relevance, and durability of the information contained within the modules for this patient population.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationMetrics associated with duration of time spent on the website were not collected because this metric can be confounded by factors such as internet connection speed, the ability of participants to access a page and leave the room, and the fact that more viewing is not linearly tied with better outcomes.
“Similarly metrics associated with duration of time spent on the website was not collected given that this metric can be confounded by factors such as internet connection speed, the ability of participants to access a page and leave the room, and the fact that more viewing is not linearly tied with better outcomes [20].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [20] Danaher BG Seeley JR Methodological issues in research on web-based behavioral interventions Ann Behav Med 2009 38 1 28 39 19806416 PMC3846298 source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningNot everyone with fibromyalgia will benefit from this intervention.
“As is the case with pharmacological agents, not everyone with FM will benefit from this intervention.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningThe use of such a delivery platform has application in the context of primary care where clinical practice has not been able to take full advantage of evidence-based non-pharmacological interventions for fibromyalgia.
“The use of such a delivery platform has application in the context of primary care where clinical practice has not been able to take full advantage of evidence-based non-pharmacological interventions for FM.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Integration of non-pharmacological interventions into routine clinical care for fibromyalgia has been slow.
“yet the integration of non-pharmacological interventions into routine clinical care has been slow.”
The paper relies on this without support.
Barriers to integrating non-pharmacological interventions into routine fibromyalgia care include lack of physician knowledge or time, limited access to qualified therapists, insufficient third-party coverage, and patient travel burden.
“Potential barriers to integration include: lack of physician knowledge or time to implement non-pharmacological approaches, limited access to qualified therapists, insufficient third party coverage of non-pharmacological approaches, and patient burden associated with traveling to and from therapy.”
The paper relies on this without support.
Most patients with fibromyalgia do not receive evidence-based non-pharmacological components of care.
“Thus, most patients with FM do not receive these evidence-based components of care.”
The paper relies on this without support.
To date, no web-based interventions have been studied addressing fibromyalgia.
“but to date, no web-based interventions have been studied addressing the complicated issues associated with FM.”
The paper relies on this without support.
CBT works best when developed to target a specific type of change.
“However, while being theoretically grounded in common principles of behavioral and cognitive change, CBT works best when developed to target a specific type of change.”
The paper relies on this without support.
The efficacy of the cognitive and behavioral skills was not in question.
“As the efficacy of the cognitive and behavioral skills were not in question, and we were not challenging the potential superiority of face-to-face modalities when available, it was our intent to evaluate the WEB-SM program in the clinical context in which it would be most likely applied.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Two studies were excluded because cognitive behavioural therapy was delivered over the Internet without contact with a psychotherapist.
“We excluded two studies because CBTs were delivered by Internet without any contact with a psychotherapist (Williams et al., 2010;Menga et al., 2014).”
From Efficacy, acceptability and safety of cognitive behavioural therapies in fibromyalgia syndrome – A systematic review and meta-analysis of randomized controlled trials (2018) · cites this paper as Williams et al., 2010
One of the excluded Internet-delivered studies had been in the first version of the review.
“One of these studies was included in the first version of the review (Williams et al., 2010).”
From Efficacy, acceptability and safety of cognitive behavioural therapies in fibromyalgia syndrome – A systematic review and meta-analysis of randomized controlled trials (2018) · cites this paper as Williams et al., 2010
A randomized trial of a website with self-management information based on CBT and no therapist contact reduced pain and increased physical functioning in individuals with fibromyalgia compared with standard care at 6-month follow-up.
“A randomized trial of an intervention consisting of a website with self-management information based on CBT and no therapist contact was found to reduce pain and increase physical functioning in individuals with fibromyalgia, compared with a control group receiving standard care alone, at a 6-month follow-up [17].”
Statistics that don’t add up
Each reported p-value recomputed from its test statistic and degrees of freedom.
p-value fits an unstated one-tailed test: t(33)=2.26, p < .03
MinorThe paper reports p < .03 here; recomputing from the test statistic and its degrees of freedom gives p = .031 (two-tailed). The reported value is what a one-tailed test gives, but the paper does not say near this result that a one-tailed test was used.
Reported p < .03 · recomputed p = .031
“t(33)=2.26, p<.03”
p-value fits an unstated one-tailed test: t(48)=2.19, p < .03
MinorThe paper reports p < .03 here; recomputing from the test statistic and its degrees of freedom gives p = .033 (two-tailed). The reported value is what a one-tailed test gives, but the paper does not say near this result that a one-tailed test was used.
Reported p < .03 · recomputed p = .033
“t(48)=2.19, p<.03”
p-value fits an unstated one-tailed test: F(1,115)=5.67, p < .01
MinorThe paper reports p < .01 here; recomputing from the test statistic and its degrees of freedom gives p = .019. The reported value is what a one-tailed test gives, but the paper does not say near this result that a one-tailed test was used.
Reported p < .01 · recomputed p = .019
“F(1,115)=5.67, p<.01”
p-value fits an unstated one-tailed test: t(45)=2.27, p < .02
MinorThe paper reports p < .02 here; recomputing from the test statistic and its degrees of freedom gives p = .028 (two-tailed). The reported value is what a one-tailed test gives, but the paper does not say near this result that a one-tailed test was used.
Reported p < .02 · recomputed p = .028
“t(45)=2.27, p<.02”
Statistics recomputed
Every reported test result, recomputed from its test statistic and degrees of freedom. A result shows as not adding up only once an independent check has confirmed it.
- Doesn’t add upF(1, 115) = 5.67reported p < .01 · recomputed p = .019
“F(1,115)=5.67, p < .01”
- Doesn’t add upt(48) = 2.19reported p < .03 · recomputed p = .033
“t(48)=2.19, p < .03”
- Doesn’t add upt(45) = 2.27reported p < .02 · recomputed p = .028
“t(45)=2.27, p < .02”
- Doesn’t add upt(33) = 2.26reported p < .03 · recomputed p = .031
“t(33)=2.26, p < .03”
- ConsistentF(1, 115) = 5.08reported p < .03 · recomputed p = .026
“F(1,115)=5.08, p < .03”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Pain-test p-value does not match its F statistic
MinorFor an F statistic of 5.67 with 1 and 115 degrees of freedom, the p-value is approximately 0.019, not less than 0.01.
“p<.01”
“F(1,115)=5.67”
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Self-citationThe operant side of behavior therapy.
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“, [10,14,46]); but to date, no web-based intervention has been studied addressing the complicated issues associated with FM.”
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Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial
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Self-citationJohnson, S. S., Levesque, D. A., Broderick, L. E., Bailey, D. G., & Kerns, R. D. (2017) · JMIR Medical Informatics · doi:10.2196/medinform.7117 · Cited by 23 · see citing works
Catella, S., Gendreau, R. M., Kraus, A. C., Vega, N., Rosenbluth, M. J., Soefje, S., Malhotra, S., Luciano, J. V., McCracken, L. M., Williams, D. A., et al. (2024) · Journal of Behavioral Medicine · doi:10.1007/s10865-023-00429-3 · Cited by 23 · see citing works
Self-citationBrummett, C. M., & Clauw, D. J. (2011) · Current Opinion in Anaesthesiology · doi:10.1097/aco.0b013e32834a1091 · Cited by 21 · see citing works
Self-citationAssessment of Research Quality of Telehealth Trials in Pain Management: A Meta‐Analysis
McGeary, D. D., McGeary, C. A., Gatchel, R. J., Allison, S., & Hersh, A. (2013) · Pain Practice · doi:10.1111/j.1533-2500.2012.00601.x · Cited by 19 · see citing works
Pain Assessment–Can it be Done with a Computerised System? A Systematic Review and Meta-Analysis
Pombo, N. G. C. C., García, N. M., Bousson, K., Spinsante, S., & Chorbev, I. (2016) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph13040415 · Cited by 18 · see citing works
Chew, M. T., Chan, C., Kobayashi, S., Cheng, H. Y., Wong, T. M., & Nicholson, L. L. (2023) · Pain Practice · doi:10.1111/papr.13227 · Cited by 18 · see citing works
“The other study used a modified Client Satisfaction Questionnaire reporting higher general satisfaction (91%) and helpfulness (78%) for the online intervention compared with the standard care control group (73% and 44% respectively).(55) Knowledge or skills acquisition Three studies reported outcomes on knowledge or s…”
ResultHiggins, D. M., Buta, E., Williams, D. A., Halat, A. M., Bair, M. J., Heapy, A. A., Krein, S. L., Rajeevan, H., Rosen, M. I., & Kerns, R. D. (2019) · Pain Practice · doi:10.1111/papr.12861 · Cited by 18 · see citing works
Self-citationCollinge, W., Yarnold, P. R., & Soltysik, R. C. (2013) · North American Journal of Medical Sciences · doi:10.4103/1947-2714.118920 · Cited by 17 · see citing works
What you can do for your fibromyalgia patient
Gota, C. E. (2018) · Cleveland Clinic Journal of Medicine · doi:10.3949/ccjm.85gr.18002 · Cited by 17 · see citing works
Donisi, V., Lucia, A. D., Pasini, I., Gandolfi, M., Schweiger, V., Piccolo, L. D., & Perlini, C. (2023) · Healthcare · doi:10.3390/healthcare11131845 · Cited by 17 · see citing works
- Authors
- Williams, D. A., Kuper, D., Segar, M., Mohan, N., Sheth, M., & Clauw, D. J.
- Affiliations
- University of Pittsburgh (US)
- Avera McKennan Hospital & University Health Center (US)
- University of Michigan (US)
- Corresponding author
- Williams, David A.
- Venue
- Pain
- Published
- 2010-12
- Volume
- 151
- Issue
- 3
- Pages
- 694-702
- ISSN
- 0304-3959 (ISSN-L)
- PMC
- PMC2972378
- OpenAlex
- W1971050325
- Semantic Scholar
- d8c2bb624d1937bec19e632bf6f0a6150418b789
- Cited by
- 210
- References
- 80
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 7 · 2023: 23 · 2022: 16 · 2021: 14 · 2020: 19 · 2019: 7 · 2018: 11 · 2017: 18 · 2016: 17 · 2015: 15 · 2014: 17 · 2013: 13 · 2012: 13
- FWCI
- 7.65
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- NIAMS/NIH (R01-AR050044)
- DAMD (17-00-2-0018)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- fibromyalgia, online intervention, self-management program, physical activity, relaxation techniques, cognitive-behavioral pain management, non-pharmacological treatment, analgesia, physical function, fatigue, sleep, anxiety, depressive symptoms, routine clinical practice
- MeSH terms
- Behavior Therapy, Exercise Therapy, Fibromyalgia, Humans, Surveys and Questionnaires, Self Care, Severity of Illness Index, Treatment Outcome, Telemedicine, Internet
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