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Cited by 61Musculoskeletal pain and rehabilitationPregnancy-related medical researchPain Management and Treatment

Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial

Open access
Sharma, Saurab, Jensen, Mark P, Moseley, G Lorimer, Abbott, J Haxby·2019·BMJ Open
DOI 10.1136/bmjopen-2018-026874PMC PMC6475174
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Abstract

Objectives: The aims of this study were to: (1) develop pain education materials in Nepali and (2) determine the feasibility of conducting a randomised clinical trial (RCT) of a pain education intervention using these materials in Nepal. Design: A two-arm, parallel, assessor-blinded, feasibility RCT. Setting: A rehabilitation hospital in Kathmandu, Nepal. Participants: Forty Nepalese with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women). Interventions: Eligible participants were randomised, by concealed, 1:1 allocation, to one of two groups: (1) a pain education intervention and (2) a guideline-based physiotherapy active control group intervention. Each intervention was delivered by a physiotherapist in a single, 1-hour, individualised treatment session. Primary outcome measures: The primary outcomes were related to feasibility: recruitment, retention and treatment adherence of participants, feasibility and blinding of outcome assessments, fidelity of treatment delivery, credibility of, and satisfaction with, treatment. Assessments were performed at baseline and at 1 week post-treatment. Secondary outcome measures: Pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life. Statistical analyses were conducted blind to group allocation. Results: Forty participants were recruited. Thirty-eight participants (95%) completed the 1-week post-treatment assessment. Most primary outcomes surpassed the a priori thresholds for feasibility. Several findings have important implications for designing a full trial. Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group. Pain intensity would seem an appropriate outcome for a full clinical trial. One minor adverse event was reported. Conclusion: We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted. Trial registration number: NCT03387228; Results.

AI snapshot

Written from the paper’s full text.

TL;DR

This two-arm, assessor-blinded feasibility RCT in Kathmandu, Nepal, developed Nepali pain education materials and tested whether a full trial of pain education versus guideline-based physiotherapy for non-specific low back pain would be feasible. Seven of eight a priori feasibility criteria were met, and the authors concluded that a full RCT is feasible and warranted.

Key findings

  • Forty participants were randomised (20 per arm); 38 (95%) completed the 1-week post-treatment assessment, and attrition was 5% in each group, below the a priori maximum of 20%.
  • Seven of eight a priori feasibility criteria were met; the unmet criterion was difficulty level, because 75% of participants in both groups rated the treatment as “easy,” contravening the a priori cut-off of 50%.
  • Secondary exploratory analyses favoured pain education over control for pain intensity (mean difference=3.56, 95% CI 0.21 to 6.91) and pain catastrophising (mean difference=6.16, 95% CI 0.59 to 11.72).
  • One minor adverse event was reported: a control-group participant had lower extremity pain after cycling for 20 min, lasting 2 days.

Methods

  • The study had two stages: development of culturally adapted Nepali pain education materials based on “Explain Pain,” followed by a two-arm, parallel, assessor-blinded feasibility RCT at a rehabilitation hospital in Kathmandu.
  • Participants were 40 Nepalese adults with non-specific low back pain (mean [SD] age 41 [14] years; 12 [30%] women), randomised 1:1 by concealed allocation to a 1-hour pain education session or a 1-hour guideline-based physiotherapy active control session; assessments occurred at baseline and 1 week post-treatment.
  • Primary outcomes were feasibility-related (recruitment, retention, adherence, blinding, fidelity, credibility, satisfaction); secondary outcomes included pain intensity, pain interference, pain catastrophising, sleep disturbance, resilience, global rating of change, depression and quality of life, analysed with two-group t-tests for descriptive purposes, blind to group allocation.

Limitations

  • The paper states that follow-up was shorter than would be used in a full clinical trial, treatment fidelity was not assessed because resources were unavailable, current practice at the site differed from guidelines and made compliance harder, no physical activity measure was included, and the experimental treatment was delivered by the primary author, which may have communicated more enthusiasm for the experimental group.
  • The paper also notes that secondary outcomes were not corrected for multiple analyses and were therefore at risk of false-positive results, and that the study was not powered to detect between-group differences in secondary outcomes.
  • Evident from the text: the trial was small (40 participants), single-centre, and conducted in a specific Nepalese rehabilitation hospital setting, with mostly male participants, limiting generalisability.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1136/bmjopen-2018-026874

Cites

Statistics

Nothing to recompute.

Claims the paper makes

0 of 50 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    Pain education produced a larger decrease in pain catastrophising than control (mean difference=6.16 [95% CI 0.59 to 11.72]).

    “Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group.”
    Quote in the paperSubstantial claim
  • Findingown data

    Pain education produced a larger decrease in pain intensity than control (mean difference=3.56 [95% CI 0.21 to 6.91]).

    “Secondary analyses suggest clinical benefit of pain education over the control intervention, with larger decrease in pain intensity (mean difference=3.56 [95% CI 0.21 to 6.91]) and pain catastrophising (mean difference=6.16 [95% CI 0.59 to 11.72]) in the pain education group.”
    Quote in the paperSubstantial claim
  • Findingown data

    Forty participants were recruited.

    “Forty participants were recruited.”
    • Also stated in: § Results · plain
      “Recruitment was stopped after achieving the desired sample size of 40.”
    • Also stated in: § Primary (feasibility) outcomes · plain
      “All 40 participants (100%) who met the inclusion criteria provided written informed consent and were randomised to one of the study arms.”
    Quote in the paperSubstantial claim
  • Findingown data

    Thirty-eight participants (95%) completed the 1-week post-treatment assessment.

    “Thirty-eight participants (95%) completed the 1-week post-treatment assessment.”
    Quote in the paperSubstantial claim
  • Findingnone given

    Most primary outcomes surpassed the a priori thresholds for feasibility.

    “Most primary outcomes surpassed the a priori thresholds for feasibility.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 29
  • May combine two claims. 51
  • The quote only partly states this claim. 2

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data

    One minor adverse event was reported.

    “One minor adverse event was reported.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Participants were adherent to treatment in both groups, with significantly more adherence reported by the CG participants.

    “Participants were adherent to the treatment in both groups, with significantly more adherence reported by the CG participants.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The majority of participants (75%) reported both treatments as easy, with no significant between-group difference in difficulty score.

    “Majority of the participants (75%) reported both treatments as easy. There were no significant between-group difference in difficulty score.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

    Findingown data

    The difficulty level of the intervention feasibility criterion was not met.

    “Difficulty level of the intervention | No”
    Quote in the paperNot a substantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data

    The assessor correctly guessed group allocation for 12 (60%) in PEG and 11 (55%) in CG, with p=0.756.

    “Assessor correctly guessed the group allocation slightly more often for the PEG than the CG.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Satisfaction scores were similar between groups with non-significant between-group difference.

    “Satisfaction of treatment scores were similar between groups with non-significant between group difference.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The main reasons for unwillingness to participate were wanting comprehensive physiotherapy as an in-patient (n=8), not wanting to pay for treatment (n=6), not having time (n=6), and wanting electrotherapy for 1 week because it was recommended by their physician (n=5).

    “The main reasons for unwillingness to participate were: (1) wanting to receive comprehensive physiotherapy treatment as an in-patient (n=8), (2) not wanting to pay for treatment (n=6), (3) not having time to participate in the study and complete the post-treatment assessment at 1 week (n=6) and (4) wanting to receive electrotherapy treatment for 1 week because it was recommended by their physician”
    Quote in the paperNot a substantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data

    Attrition rate was 1 (5%) in each group, with no difference between groups.

    “No difference in attrition rates between groups.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Seventy candidates were invited to participate; 28 (70%) were recruited from the data collection centre and 12 (30%) from community advertisements.

    “Seventy candidates were invited to participate in the study. Twenty-eight participants (70%) were recruited from the data collection centre; 12 (30%) from community advertisements.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The study developed a culturally suitable pain education programme using local patient stories before using it in the feasibility trial.

    “We developed a culturally suitable pain education programme using local patient stories before using it in the feasibility trial.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The assessor's guess was correct for 12 participants (60%) in the PEG condition and for 11 participants (55%) in the CG condition.

    “The assessor’s guess was correct for 12 participants (60%) in the PEG condition and for 11 participants (55%) in the CG condition.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Twelve out of 38 patients who completed the post-treatment assessment at 1 week (32%; five in PEG and seven in CG) wished to receive their regular physiotherapy treatment (mostly electrotherapy) at the centre between the two assessment time-points; these participants did receive this treatment as requested.

    “Twelve out of 38 patients who completed the post-treatment assessment at 1 week (32%; five in the PEG and seven in the CG) wished to receive their regular physiotherapy treatment (mostly electrotherapy) at the centre between the two assessment time-points; these participants did receive this treatment as requested.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Many participants in the CG were keen to receive pain education intervention, which they did (n=15) after post-treatment assessment at 1 week.

    “Similarly, many participants in the CG were keen to receive pain education intervention, which they did (n=15) after post-treatment assessment at 1 week.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Five physiotherapists initially trained in guideline-based care left the treatment centre during recruitment and were replaced by four physiotherapists who had not been trained in guideline-based care as part of the study.

    “Moreover, five of the physiotherapists who were initially trained in the guideline-based care prior to the initiation of the study left the treatment centre during the trial recruitment period. They were replaced by four physiotherapists who therefore had not been trained in guideline-based care as part of this study.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The attrition rate was 5%, well below the a priori maximum rate of 20%.

    “our attrition rate (5%) was well below our a priori maximum rate of 20%”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Statistically significant improvements over time were observed for 7/8 outcomes in the PEG condition and 4/8 outcomes in the CG condition.

    “Statistically significant improvements over time were observed for 7/8 outcomes in the PEG condition and 4/8 outcomes in the CG condition.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Adherence to intervention and treatment satisfaction were similar in both groups.

    “Adherence to intervention and treatment satisfaction were similar in both groups (table 2).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The credibility scores of the two conditions at 1-week assessment and average treatment time were similar.

    “The credibility scores of the two conditions at 1-week assessment and average treatment time were similar (table 2).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Of the 13 participants who did not accept random allocation, 5 (7%) wanted electrotherapy specifically and 8 (11%) wanted admission for comprehensive physiotherapy twice daily for a week.

    “Of the 13 participants who did not accept random allocation, 5 (7%) wanted to receive electrotherapy treatment specifically and 8 (11%) wanted to be admitted at the centre to receive comprehensive physiotherapy treatment (including electrotherapy) twice a day for a week as advised by their treating physician or physiotherapists.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    One participant in the CG reported lower extremity pain after cycling for 20 min; the increase lasted for 2 days and then subsided.

    “One participant in the CG reported lower extremity pain after cycling for 20 min. The increase in her lower extremity pain lasted for 2 days and then subsided.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The assessor identified clues that may have influenced a correct guess: duration of treatment time, patients reporting the treatment as interesting, and the treating therapist's description of the treatment as interactive.

    “On questioning, the assessor identified some clues that may have influenced a correct guess: (1) ‘duration of treatment time’ (see below) (n=5; three correct and two incorrect guesses), (2) patients reporting the treatment as ‘interesting’ (n=2; both incorrect guesses) and (3) the treating therapist’s description of the treatment as interactive (n=1; correct guess).”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data

    The screener reported that the screening procedures were acceptable, but there were two problems.

    “The screener reported that the screening procedures were acceptable, but there were two problems.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Significant between-group differences were found in favour of PEG, and the apparent effect was substantial on pain intensity and pain catastrophising.

    “Although assessment of the effectiveness of the interventions on the secondary outcomes was not a primary aim of this study, the significant between-group differences that were found were in favour of PEG, and the apparent effect was substantial on two key target outcomes: pain intensity and pain catastrophising (table 4).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingnone given

    Treatment credibility and satisfaction were high for both groups even though participants did not receive the treatment they expected.

    “Treatment credibility and satisfaction were high for both groups (even though the participants did not receive the treatment they expected).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The authors had planned a full clinical trial in 2015 but were unable to recruit participants because clinicians were too busy to collect data and provide interventions as per protocol, and they encountered difficulty ensuring access to an assessor blinded to group allocation.

    “For example, we had planned a full clinical trial in 201557 but were unable to recruit participants because the clinicians were too busy to collect data and provide interventions as per protocol, and we encountered difficulty ensuring access to an assessor blinded to group allocation because of multiple responsibilities of the clinicians.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [57] ClinicalTrials.gov. Identifier: NCT02343315 . Are Supervised Exercises and TENS necessary along with prescribed home exercises for chronic low back pain? Bethesda (MD): National Library of Medicine (US), 2015.

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    A full RCT of pain education for back pain in Nepal is feasible and warranted.

    “We conclude that a full RCT of pain education for back pain in Nepal is feasible and warranted.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    The TIDieR checklist was used to plan and report the study interventions.

    “We used the Template for Intervention Description and Replication (TIDieR) Checklist to plan and report the study interventions.34 35”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [34] Yamato, 2016, The TIDieR checklist will benefit the physical therapy profession, J Orthop Sports Phys Ther source

      Not checked in the free run.

    • cites [35] Hoffmann TC , Glasziou PP , Boutron I , et al . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687.doi:10.1136/bmj.g1687 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    Feasibility was determined based on a priori criteria.

    “Feasibility was to be determined based on a priori criteria.31”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [31] Sharma S , Jensen MP , Moseley GL , et al . Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial). BMJ Open 2018;8:e022423.doi:10.1136/bmjopen-2018-022423 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    The trial protocol was registered at ClinicalTrials.gov.

    “We registered the trial protocol at ClinicalTrials.gov.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductcitation

    The SPIRIT statement was used during development of the protocol and the CONSORT extension for pilot and feasibility randomised trials was followed for reporting.

    “We used the Standard Protocol Items: Recommendations for Interventional Trials statement32 during the development of the protocol and followed the Consolidated Standards of Reporting Trials statement extension for a pilot and feasibility randomised trials33 for reporting.”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [32] Chan AW , Tetzlaff JM , Gøtzsche PC , et al . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013;346:e7586.doi:10.1136/bmj.e7586 source

      Not checked in the free run.

    • cites [33] Eldridge SM , Chan CL , Campbell MJ , et al . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:i5239.doi:10.1136/bmj.i5239 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable).

    Interpretationown data

    Pain intensity would seem an appropriate outcome for a full clinical trial.

    “Pain intensity would seem an appropriate outcome for a full clinical trial.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The group allocation was revealed to study participants and intervention providers only after completion of the baseline assessment.

    “The group allocation was revealed to the study participants and intervention providers only after completion of the baseline assessment.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Patients with LBP and non-clinician volunteers provided significant feedback in the development of the Nepalese pain education materials.

    “Patients with LBP and non-clinician volunteers provided significant feedback in the development of the Nepalese pain education materials.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    The limited available literature on LBP in Nepal indicates LBP prevalence of between 35% and 65% and that prevalence will probably increase in the next decade.

    “The limited available literature on LBP in Nepal indicates LBP prevalence of between 35% and 65%4 5 and that prevalence will probably increase in the next decade.3”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites [4] Sharma, 2016, Pain-related factors associated with lost work days in nurses with low back pain: a cross-sectional study, Scand J Pain source

      Not checked in the free run.

    • cites [5] source

      Not checked in the free run.

    • cites [3] Buchbinder, 2018, Low back pain: a call for action, Lancet source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Many high-income countries are moving away from primarily drug and surgical management of LBP because of their associated risks and costs, and general lack of efficacy, while such interventions are increasingly provided in Nepal.

    “Remarkably, although many high-income countries are moving away from primarily drug and surgical management of LBP because of their associated risks and costs, and general lack of efficacy,10 such interventions are now increasingly provided in Nepal.11 12”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites [10] source

      Not checked in the free run.

    • cites [11] Bhattarai, 2013, A study on factors affecting low back pain and safety and efficacy of NSAIDs in acute low back pain in a tertiary care hospital of Western Nepal, J Clin Diagn Res

      Not checked in the free run.

    • cites [12] Bajracharya, 2007, Clinico-epidemiological study of spinal injuries in a predominantly rural population of eastern Nepal: A 10 years' analysis, Indian J Orthop source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Allocation concealment was performed using sequentially numbered opaque, sealed envelopes, prepared by JHA, and maintained until the interventions were assigned.

    “Allocation concealment was performed using sequentially numbered opaque, sealed envelopes, prepared by JHA, and maintained until the interventions were assigned to the study participants.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisecitation

    For chronic back pain, recommendations are education, exercise and psychological therapies.

    “For chronic back pain, recommendations are education, exercise and psychological therapies.6–9”
    Quote in the paperSubstantial claim0 of 4 sources checked
    • cites [6] source

      Not checked in the free run.

    • cites [7] Van Wambeke P , Desomer A , Ailiet L , et al . Low back pain and radicular pain: assessment and management. KCE Report 2017:287.

      Not checked in the free run.

    • cites [8] Almeida, 2018, Primary care management of non-specific low back pain: key messages from recent clinical guidelines, Med J Aust source

      Not checked in the free run.

    • cites [9] Foster, 2018, Prevention and treatment of low back pain: evidence, challenges, and promising directions, Lancet source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductcitation

    Sample size estimation was performed to achieve the primary feasibility outcomes goals, not to detect differences in the secondary treatment effects outcomes.

    “Sample size estimation was performed to achieve the primary feasibility outcomes goals, as described in the protocol31 and registration documents, and not to detect differences in the secondary treatment effects outcomes.46”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [31] Sharma S , Jensen MP , Moseley GL , et al . Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial). BMJ Open 2018;8:e022423.doi:10.1136/bmjopen-2018-022423 source

      Not checked in the free run.

    • cites [46] source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    Although education is almost universally recommended for LBP, there are no clear curricula for delivering it, and little attention is given to training, methods, settings or context.

    “Although education is almost universally recommended for LBP, there are no clear curricula for delivering it, and little attention is given to training, methods, settings or context.13”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [13] Moseley GL . Whole of community pain education for back pain. Why does first-line care get almost no attention and what exactly are we waiting for? Br J Sports Med 2018:bjsports-2018-099567.doi:10.1136/bjsports-2018-099567 source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    This form of pain education was developed in Australia and has been adapted in numerous Western countries, demonstrating mixed results for effectiveness for managing LBP.

    “This form of pain education (widely known as ‘Explain Pain’ or ‘Pain Neuroscience Education’)15–24 was developed in Australia and has been adapted in numerous Western countries, demonstrating mixed results for effectiveness for managing LBP.15 17 21 23–25”
    Quote in the paperNot a substantial claim0 of 10 sources checked
    • cites [15] source

      Not checked in the free run.

    • cites [16] Butler DS , Moseley GL . Explain pain. 2nd edn: Noigroup Publications, 2013.

      Not checked in the free run.

    • cites [17] Malfliet, 2018, Effect of pain neuroscience education combined with cognition-targeted motor control training on chronic spinal pain: a randomized clinical trial, JAMA Neurol source

      Not checked in the free run.

    • cites [18] Louw, 2013, Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy, Am J Phys Med Rehabil source

      Not checked in the free run.

    • cites [19] Louw, 2016, Three-year follow-up of a randomized controlled trial comparing preoperative neuroscience education for patients undergoing surgery for lumbar radiculopathy, J Spine Surg source

      Not checked in the free run.

    • cites [20] source

      Not checked in the free run.

    • cites [21] Rizzo, 2018, Hypnosis enhances the effects of pain education in patients with chronic nonspecific low back pain: a randomized controlled trial, J Pain source

      Not checked in the free run.

    • cites [22] Robins, 2016, Pain neuroscience education: state of the art and application in pediatrics, Children source

      Not checked in the free run.

    • cites [23] van Ittersum, 2014, Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial, Pain Pract source

      Not checked in the free run.

    • cites [24] Werner, 2016, Cognitive patient education for low back pain in primary care: a cluster randomized controlled trial and cost-effectiveness analysis, Spine source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Unblinding of group allocation occurred after all planned analyses were complete.

    “Unblinding of group allocation occurred after all planned analyses were complete.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The pain education intervention was delivered by the principal investigator, who had received extensive training in Explain Pain via NOIgroup Professional Development and one-on-one mentoring with pain education experts.

    “The principal investigator (SS), who has received extensive training in Explain Pain via NOIgroup Professional Development and one-on-one mentoring with pain education experts, delivered the treatment.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    Allocation sequence was generated in random blocks of 4 and 6 using www.random.org by a researcher not involved in recruitment.

    “Allocation sequence was generated in random blocks of 4 and 6 using www.random.org by a researcher (JHA) who was not involved in recruitment.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductreasoning

    The exploratory analysis of between-group differences in secondary outcomes used two-group t-tests, with the understanding that the study was not powered to detect statistically significant between-group differences in secondary outcomes.

    “We planned the exploratory analysis of between-group differences in the secondary outcome measures using two-group t-tests, with the understanding that the current study was not powered to detect statistically significant between-group differences in the secondary outcomes.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Most controlled trials do not adequately examine assessor blinding, even though it is widely considered a very important component of good study design.

    “Most controlled trials do not adequately examine assessor blinding,53 even though it is widely considered a very important component of good study design.54”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [53] source

      Not checked in the free run.

    • cites [54] Schulz, 2002, Blinding in randomised trials: hiding who got what, The Lancet source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

    Premisecitation

    Patients' stories provide a context and meaning of their health problems, may be a therapeutic intervention in itself, and are important to establish a good doctor-patient relationship.

    “The patients’ stories in fact provide a context and meaning of their health problems,49 which may be a therapeutic intervention in itself, and are important to establish a good doctor–patient relationship.50”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [49] source

      Not checked in the free run.

    • cites [50] Richards T . Listen to patients first. BMJ 2014;349:g5765.doi:10.1136/bmj.g5765 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    Seven of the eight a priori feasibility criteria were met, which suggests that a clinical trial to evaluate the effectiveness of pain education and evidence-based physiotherapy treatment in Nepal is feasible.

    “Seven of the eight a priori feasibility criteria were met, which suggests that a clinical trial to evaluate the effectiveness of pain education and evidence-based physiotherapy treatment in Nepal is feasible.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Interpretationown data

    These results add pertinence to the feasibility results; a full-scale clinical trial appears warranted.

    “However, these results add pertinence to the feasibility results; a full-scale clinical trial appears warranted.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    Pain education intervention appears to be a less resource-intensive alternative to current practice and could be delivered outside the public health system in community settings.

    “Pain education intervention appears to be a less resource-intensive alternative to current practice and could be delivered outside of the public health system, in community settings, although the costs and time of physiotherapist would be no different from guideline-based care as delivered in a physiotherapy department.”
    Quote in the paperSubstantial claim
    • Rests on an assumption: Nepalese individuals are often poor, and the Nepalese public health system is resource poor.

  • Classified as probably not a substantial claim.

    Interpretationown data

    Secondary outcome data findings suggesting a beneficial effect in the PEG condition appear to support making a change to increase the difficulty of the material.

    “That secondary outcome data findings suggesting a beneficial effect in the PEG condition appears to support making such a change.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductreasoning

    These are secondary outcomes, not corrected for multiple analyses and therefore at risk of false positive results.

    “It should be remembered that these are secondary outcomes, not corrected for multiple analyses and therefore at risk of false positive results.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationnone given

    There were instances when excluding an accompanying family member would have reduced data collection time and possibly improved the accuracy of answers.

    “There were instances when excluding an accompanying family member would have reduced the data collection time and possibly improved the accuracy of the answers.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Interpretationnone given

    The costs and time of a physiotherapist would be no different from guideline-based care as delivered in a physiotherapy department.

    “although the costs and time of physiotherapist would be no different from guideline-based care as delivered in a physiotherapy department.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

    Interpretationnone given

    Pain education might require more training of therapists, although training in guideline-based care may be necessary too.

    “Pain education might require more training of therapists, although training in guideline-based care may be necessary too.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim. May combine two claims.

    Premisecitation

    Relationships patients have with those around them play an important role in the experience of pain and what people do about it; exclusion of important others may disengage the patient or instil barriers to participation.

    “However, the relationships patients have with those around them play an important role in the experience of pain51 52 and what people do about it51; exclusion of important others at a critical time may also disengage the patient or instil other barriers to their participation in the project.”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites [51] source

      Not checked in the free run.

    • cites [52] source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    Blinding appeared to be successful, and contamination appeared to be avoided.

    “Blinding appeared to be successful, and contamination appeared to be avoided.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    Limiting the number of patient recruitments performed in a single day to two may also have helped avoid contamination.

    “Limiting the number of patient recruitments performed in a single day to two may also have helped avoid contamination, but to see no evidence of contamination was surprising.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductcitation

    The protocol was submitted prior to data collection and reporting remained transparent.

    “we submitted our protocol prior to data collection and remained transparent in all reporting.56”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [56] Lee, 2018, Reproducible and replicable pain research: a critical review, Pain source

      Not checked in the free run.

  • May combine two claims.

    Study design and conductcitation

    Outcomes were consistent with NIH recommendations on research standards for chronic LBP and core outcome sets for LBP research.

    “outcomes were consistent with NIH recommendations on research standards for chronic LBP38 and core outcome sets for LBP research39”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites [38] source

      Not checked in the free run.

    • cites [39] Chiarotto, 2018, Core outcome measurement instruments for clinical trials in nonspecific low back pain, Pain source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The experimental group treatment was provided by the primary author, who may have inadvertently communicated more enthusiasm for the experimental group treatment than the therapists providing the CG treatment, which may have influenced the study findings.

    “Finally, the experimental group treatment was provided by the primary author of the study who may have inadvertently communicated more enthusiasm for the experimental group treatment than the therapists providing the CG treatment; this may have influenced the study findings.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationreasoning

    The current practice in LBP management at the study site was very different from clinical practice guidelines, which made it harder for the physiotherapists to comply with guideline-based care.

    “That the current practice in the LBP management at the study site was very different from clinical practice guidelines made it harder for the physiotherapists to comply with the guideline-based care.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductown data

    The study did not include any measure of physical activity as a secondary outcome, despite improved physical activity being one aim of pain education.

    “Another limitation was that we did not include any measure of physical activity as a secondary outcome, despite improved physical activity being one aim of pain education.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Premisecitation

    Conducting a feasibility study is an important step before conducting a full clinical trial, especially in a setting where a high-quality clinical trial has never been conducted.

    “Conducting a feasibility study is an important step before conducting a full clinical trial,47 especially in a setting where a high-quality clinical trial has never been conducted, which lacks recommendations from previous experiences for such a study.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [47] source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    A clinical trial to evaluate the effectiveness of pain education and evidence-based physiotherapy treatment in Nepal is feasible and warranted, although some minor modifications are required.

    “We conclude that a clinical trial to evaluate the effectiveness of pain education and evidence-based physiotherapy treatment in Nepal is feasible and warranted, although some minor modifications are required.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductnone given

    The study successfully blinded the assessor and analyst and assessed both blinding and contamination.

    “we successfully blinded the assessor and analyst and assessed both blinding and contamination”
    Quote in the paperNot a substantial claim
65 of 65

  • The paper relies on this without support.

    The study is the first to examine the feasibility of a clinical trial on low back pain in Nepal.

    “This is the first study to examine the feasibility of a clinical trial on low back pain in Nepal.”

  • The paper relies on this without support.

    There is little or no research or clinical evidence evaluating the efficacy of any treatments for LBP in Nepal, including first-line treatments recommended elsewhere.

    “Unfortunately, there is little or no research, nor clinical evidence, that evaluates the efficacy of any treatments for LBP in Nepal, including the first-line treatments that are now recommended in clinical guidelines elsewhere.”

  • The paper relies on this without support.

    No strong evidence exists in support of effectiveness of longer versus shorter education duration.

    “Although no strong evidence exists in support of effectiveness of longer versus shorter education duration, a short education session is time efficient.”

  • The paper relies on this without support.

    Treatment that is effective in one culture may not necessarily be effective in another.

    “Treatment that is effective in one culture may not necessarily be effective in another.”

  • The paper relies on this without support.

    No reports exist of pain education being adapted or evaluated within an Eastern cultural context.

    “We know of no reports of pain education being adapted or evaluated within an Eastern cultural context.”

  • The paper relies on this without support.

    This is the first study to examine the feasibility of a clinical trial on low back pain in Nepal.

    “To our knowledge, this is the first study to examine the feasibility of a clinical trial on LBP in Nepal.”

  • The paper relies on this without support.

    Nepalese individuals are often poor, and the Nepalese public health system is resource poor.

    “Nepalese individuals are often poor, and the Nepalese public health system is resource poor.”
7 of 7

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?

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.

  • Treatment fidelity is named as an assessed primary outcome but was not assessed

    Major

    The paper includes fidelity of treatment delivery among its primary outcomes, then states that treatment fidelity was not assessed in this study.

  • Baseline credibility difference has the wrong sign

    Minor

    The baseline credibility score is 12.55 for the PEG and 12.95 for the CG, making the PEG-minus-CG difference −0.40, not 0.40. The reported confidence interval is also centred on −0.40.

    Reported 0.4 · recomputed -0.4

  • Reported control-group improvement count differs from the listed outcomes

    Minor

    The discussion says four control-group outcomes improved significantly, but the results identify only three: pain interference, depression and catastrophising. Table 4 marks those same three control-group changes as significant.

  • Control-group occupation counts total 18, not 20

    Minor

    The control-group counts across the listed primary occupations add to 18, although the group has 20 participants. The listed percentages likewise add to 90%.

    Reported 20 · recomputed 18

  • Regular physiotherapy count conflicts with Table 2

    Minor

    The prose says five PEG and seven CG participants received regular physiotherapy at the centre. Table 2 lists four and five, respectively; five and seven are its totals for all types of other treatment.

  • Adherence is described as both similar and significantly different

    Minor

    The prose calls adherence similar between groups, whereas Table 2 describes significantly greater adherence in the CG. Its reported confidence interval for days of home exercise also excludes zero.

6 of 6

No citation lists for this paper

No citation lists for this paper yet — checked again daily.

References 65 · Cited by 61

Authors
Sharma, S., Jensen, M. P., Moseley, G. L., & Abbott, J. H.
Affiliations
  • Kathmandu University (NP)
  • University of Washington (US)
  • University of South Australia (AU)
  • University of Otago (NZ)
Corresponding author
Sharma, Saurab
ORCID
Venue
BMJ Open
Publisher
BMJ
Published
2019-03
Volume
9
Issue
3
Pages
e026874
ISSN
2044-6055 (ISSN-L)
DOI
10.1136/bmjopen-2018-026874
PMC
PMC6475174
OpenAlex
W2924673143
Cited by
61
References
65
Citations by year
2026: 3 · 2025: 10 · 2024: 7 · 2023: 17 · 2022: 9 · 2021: 6 · 2020: 5 · 2019: 3 · 2018: 1
FWCI
3.56
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • UniSA Research Outputs Repository (University of South Australia) (acceptedVersion, other-oa)
  • UNSWorks (University of New South Wales, Sydney, Australia) (submittedVersion, cc-by-nc-nd)
  • Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion, cc-by-nc)
  • HighWire Press Open Archive (submittedVersion)
Funders
University of Otago
Topics
  • Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy-related medical research
  • Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Treatment
Keywords
pain education, non-specific low back pain, feasibility trial, pain catastrophizing, pain intensity, pain interference, sleep disorders, resilience, physiotherapy, Nepal, trial recruitment and retention
MeSH terms
Adult, Feasibility Studies, Humans, Male, Middle Aged, Nepal, Patient Compliance, Patient Education as Topic, Low Back Pain, Physical Therapy Modalities, Patient Outcome Assessment

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-06.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-06.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

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