Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial
Open accessAbstract
OBJECTIVE: To determine whether a systematic approach to the treatment of pain can reduce agitation in people with moderate to severe dementia living in nursing homes. DESIGN: Cluster randomised controlled trial. SETTING: 60 clusters (single independent nursing home units) in 18 nursing homes within five municipalities of western Norway. PARTICIPANTS: 352 residents with moderate to severe dementia and clinically significant behavioural disturbances randomised to a stepwise protocol for the treatment of pain for eight weeks with additional follow-up four weeks after the end of treatment (33 clusters; n = 175) or to usual treatment (control, 27 clusters; n = 177). INTERVENTION: Participants in the intervention group received individual daily treatment of pain for eight weeks according to the stepwise protocol, with paracetamol (acetaminophen), morphine, buprenorphine transdermal patch, or pregabaline. The control group received usual treatment and care. MAIN OUTCOME MEASURES: Primary outcome measure was agitation (scores on Cohen-Mansfield agitation inventory). Secondary outcome measures were aggression (scores on neuropsychiatric inventory-nursing home version), pain (scores on mobilisation-observation-behaviour-intensity-dementia-2), activities of daily living, and cognition (mini-mental state examination). RESULTS: Agitation was significantly reduced in the intervention group compared with control group after eight weeks (repeated measures analysis of covariance adjusting for baseline score, P < 0.001): the average reduction in scores for agitation was 17% (treatment effect estimate -7.0, 95% confidence interval -3.7 to -10.3). Treatment of pain was also significantly beneficial for the overall severity of neuropsychiatric symptoms (-9.0, -5.5 to -12.6) and pain (-1.3, -0.8 to -1.7), but the groups did not differ significantly for activities of daily living or cognition. CONCLUSION: A systematic approach to the management of pain significantly reduced agitation in residents of nursing homes with moderate to severe dementia. Effective management of pain can play an important part in the treatment of agitation and could reduce the number of unnecessary prescriptions for psychotropic drugs in this population. Trial registration ClinicalTrials.gov NCT01021696 and Norwegian Medicines Agency EudraCTnr 2008-007490-20.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
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?
Only one activity study measured agitation after the intervention finished, and it did not show effects at 1-week and 4-week follow-up.
“Only one study measured agitation after the intervention finished, and did not show effects at 1-week and 4-week follow-up. 24”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [24]
The Methods (Primary and secondary outcome measures) specify agitation measurement four weeks after treatment ended, but no one-week follow-up. Results (Outcome, table 3) show no statistically significant intervention effect at that four-week follow-up (P=0.058). This was a pain-treatment trial, not an activity study, and it cannot establish that only one study measured post-intervention agitation. (LLM, conf=0.88)
Experimental — accuracy not yet measuredEffective pain management has an important role and can reduce unnecessary psychotropic prescriptions.
“Effective pain management also has an important role and can reduce unnecessary psychotropic prescriptions.48”
From Assessment and management of behavioral and psychological symptoms of dementia (2015) · cites this paper as [48]
One high-quality RCT found no additional effect on agitation of individualising activities according to functional level and interest, although two lower-quality RCTs did.
“One high-quality RCT found no additional effect on agitation of individualising activities according to functional level and interest, 24 although two lower-quality RCTs did. 25,26”
From Non-pharmacological interventions for agitation in dementia: systematic review of randomised controlled trials (2014) · cites this paper as [24]
The Methods and Results (pages not provided) describe a trial of stepwise pain treatment that reduced agitation, not a trial of activities individualised by functional level and interest. The Discussion mentions a separate personalised non-drug intervention but does not report the claimed null result for individualised activities. Searches for the claim’s wording and for tailored activities found no supporting passage in this paper. (LLM, conf=0.76)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975) · Journal of Psychiatric Research · doi:10.1016/0022-3956(75)90026-6 · Cited by 88,282 · see citing works
The Neuropsychiatric Inventory: Comprehensive assessment of psychopathology in dementia
Cummings, J. L., Mega, M., Gray, K., Rosenberg-Thompson, S., Carusi, D. A., & Gornbein, J. (1994) · Neurology · doi:10.1212/wnl.44.12.2308 · Cited by 7,568 · see citing works
Consort 2010 statement: extension to cluster randomised trials
Campbell, M. K., Piaggio, G., Elbourne, D. R., Altman, D. G., & for the CONSORT Group (2012) · BMJ · doi:10.1136/bmj.e5661 · Cited by 3,510 · see citing works
CONSORT statement: extension to cluster randomised trials
Campbell, M. K., Elbourne, D. R., & Altman, D. G. (2004) · BMJ · doi:10.1136/bmj.328.7441.702 · Cited by 2,557 · see citing works
Analysing controlled trials with baseline and follow up measurements
Vickers, A. J., & Altman, D. G. (2001) · BMJ · doi:10.1136/bmj.323.7321.1123 · Cited by 2,116 · see citing works
The Hawthorne Effect: a randomised, controlled trial
McCarney, R., Warner, J. P., Iliffe, S., van Haselen, R. A., Griffin, M., & Fisher, P. (2007) · BMC Medical Research Methodology · doi:10.1186/1471-2288-7-30 · Cited by 1,730 · see citing works
A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia
Deyn, P. P. D., Rabheru, K., Rasmussen, A. M. L., Bocksberger, J. P., DAUTZENBERG, P. L. J., Eriksson, S., & LAWLOR, B. A. (1999) · Neurology · doi:10.1212/wnl.53.5.946 · Cited by 611 · see citing works
Livingston, G., Johnston, K., Katona, C., Paton, J., Lyketsos, C. G., & Old Age Task Force of the World Federation of Biological Psychiatry (2005) · American Journal of Psychiatry · doi:10.1176/appi.ajp.162.11.1996 · Cited by 591 · see citing works
The Management of Chronic Pain in Older Persons
Connelly, P. (1998) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.1998.tb01084.x · Cited by 522 · see citing works
Brodaty, H., Ames, D., Snowdon, J., Woodward, M., Kirwan, J., Clarnette, R., Lee, E., Lyons, B., & Grossman, F. (2003) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v64n0205 · Cited by 464 · see citing works
Selbæk, G., Kirkevold, Ø., & Engedal, K. (2006) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.1749 · Cited by 369 · see citing works
Lyketsos, C. G., Colenda, C. C., Beck, C. M., Blank, K., Doraiswamy, M. P., Kalunian, D. A., & Yaffe, K. S. (2006) · American Journal of Geriatric Psychiatry · doi:10.1097/01.jgp.0000221334.65330.55 · Cited by 275 · see citing works
Cohen‐Mansfield, J., Libin, A., & Marx, M. S. (2007) · The Journals of Gerontology Series A · doi:10.1093/gerona/62.8.908 · Cited by 257 · see citing works
Rinaldi, P., Spazzafumo, L., Mastriforti, R., Mattioli, P., Marvardi, M., Polidori, M. C., Cherubini, A., Abate, G., Bartorelli, L., Bonaiuto, S., et al. (2005) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.1267 · Cited by 191 · see citing works
Kovach, C. R., Logan, B. R., Noonan, P. E., Schlidt, A. M., Smerz, J. M., Simpson, M., & Wells, T. (2006) · American Journal of Alzheimer s Disease & Other Dementias® · doi:10.1177/1533317506288949 · Cited by 162 · see citing works
Who Suffers Most? Dementia and Pain in Nursing Home Patients: A Cross-sectional Study
Husebo, B. S., Strand, L. I., Moe‐Nilssen, R., BorgeHusebo, S., Aarsland, D., & Ljunggren, A. E. (2008) · Journal of the American Medical Directors Association · doi:10.1016/j.jamda.2008.03.001 · Cited by 153 · see citing works
Self-citationHusebo, B. S., Strand, L. I., Moe‐Nilssen, R., Husebo, S. B., & Ljunggren, A. E. (2010) · Scandinavian Journal of Caring Sciences · doi:10.1111/j.1471-6712.2009.00710.x · Cited by 153 · see citing works
Self-citationSheikh, K., Smith, D. S., Meade, T. W., GOLDENBERG, E., Brennan, P. J., & Kinsella, G. (1979) · International Rehabilitation Medicine · doi:10.3109/03790797909164024 · Cited by 141 · see citing works
Deberdt, W. G., Dysken, M. W., Rappaport, S. A., Feldman, P. D., Young, C. A., Hay, D. P., Lehman, D. L., Dossenbach, M. R. K., Degenhardt, E. K., & Breier, A. F. (2005) · American Journal of Geriatric Psychiatry · doi:10.1097/00019442-200508000-00012 · Cited by 129 · see citing works
RICHARD, L. (1983) · PubMed · Cited by 128 · see citing works
Chibnall, J. T., Tait, R. C., Harman, B. J., & Luebbert, R. A. (2005) · Journal of the American Geriatrics Society · doi:10.1111/j.1532-5415.2005.53572.x · Cited by 113 · see citing works
Pain treatment of agitation in patients with dementia: a systematic review
Husebo, B. S., Ballard, C. G., & Aarsland, D. (2011) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.2649 · Cited by 103 · see citing works
Self-citationAlzheimer's disease: a global challenge for the 21st century
Dartigues, J. F. (2009) · The Lancet Neurology · doi:10.1016/s1474-4422(09)70298-4 · Cited by 94 · see citing works
Opioid treatment for agitation in patients with advanced dementia
Manfredi, P. L., Breuer, B., Wallenstein, S. R., et al. (2003) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.906 · Cited by 91 · see citing works
Brief Psychosocial Therapy for the Treatment of Agitation in Alzheimer Disease (The CALM-AD Trial)
Ballard, C. G., Brown, R. G., Fossey, J., Douglas, S., Bradley, P., Hancock, J., James, I. A., Juszczak, E., Bentham, P., Burns, A. S., et al. (2009) · American Journal of Geriatric Psychiatry · doi:10.1097/jgp.0b013e3181b0f8c0 · Cited by 85 · see citing works
Self-citationCohen‐Mansfield, J., & Libin, A. (2004) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.1171 · Cited by 85 · see citing works
Cohen‐Mansfield, J., & Libin, A. (2004) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2004.08.009 · Cited by 84 · see citing works
Prevalence and correlates of disruptive behavior in patients in Norwegian nursing homes
Testad, I., Aasland, A. M., & Aarsland, D. (2007) · International Journal of Geriatric Psychiatry · doi:10.1002/gps.1766 · Cited by 77 · see citing works
Self-citationThe utility of pain assessment for analgesic use in persons with dementia
Cohen-Mansfield, J., & Lipson, S. (2008) · Pain · doi:10.1016/j.pain.2007.03.023 · Cited by 62 · see citing works
Deberdt, W. G. (2005) · American Journal of Geriatric Psychiatry · doi:10.1176/appi.ajgp.13.8.722 · Cited by 41 · see citing works
The Mahoney Pain Scale: Examining Pain and Agitation in Advanced Dementia
Mahoney, A., & Peters, L. (2008) · American Journal of Alzheimer s Disease & Other Dementias® · doi:10.1177/1533317508317524 · Cited by 39 · see citing works
Advances in the treatment of behavioral disturbances in Alzheimer’s disease
Cummings, J. L., & Knopman, D. S. (1999) · Neurology · doi:10.1212/wnl.53.5.899 · Cited by 29 · see citing works
Neuropsychiatric Inventory (NPI)
Cummings, Mega, Gray, Rosenberg-Thompson, Carusi, & Gornbein (2020) · Psychology Press eBooks · doi:10.4324/9781003076391-84 · Cited by 4 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Dementia prevention, intervention, and care
Livingston, G., Sommerlad, A., Orgeta, V., Costafreda, S. G., Huntley, J., Ames, D., Ballard, C., Banerjee, S., Burns, A., Cohen-Mansfield, J., et al. (2017) · The Lancet · doi:10.1016/s0140-6736(17)31363-6 · Cited by 6,072 · see citing works
Self-citationAssessment and management of behavioral and psychological symptoms of dementia
Kales, H. C., Gitlin, L. N., & Lyketsos, C. G. (2015) · BMJ · doi:10.1136/bmj.h369 · Cited by 1,247 · see citing works
Kales, H. C., Gitlin, L. N., Lyketsos, C. G., & Dementia, T. D. E. P. O. T. A. A. M. O. T. N. S. O. (2014) · Journal of the American Geriatrics Society · doi:10.1111/jgs.12730 · Cited by 575 · see citing works
Livingston, G., Kelly, L., Lewis-Holmes, E., Baio, G., Morris, S., Patel, N., Omar, R. Z., Katona, C., & Cooper, C. (2014) · British Journal of Psychiatry · doi:10.1192/bjp.bp.113.141119 · Cited by 426 · see citing works
Neuropsychiatric signs and symptoms of Alzheimer's disease: New treatment paradigms
Lanctôt, K. L., Amatniek, J., Ancoli‐Israel, S., Arnold, S. E., Ballard, C., Cohen‐Mansfield, J., Ismail, Z., Lyketsos, C., Miller, D. S., Musiek, E., et al. (2017) · Alzheimer's & Dementia: Translational Research & Clinical Interventions · doi:10.1016/j.trci.2017.07.001 · Cited by 395 · see citing works
Self-citationKales, H. C., Lyketsos, C. G., Miller, E. M., & Ballard, C. (2019) · International Psychogeriatrics · doi:10.1017/s1041610218000534 · Cited by 220 · see citing works
Self-citationFox, C., Crugel, M., Maidment, I., Auestad, B. H., Coulton, S., Treloar, A., Ballard, C., Boustani, M., Katona, C., & Livingston, G. (2012) · PLoS ONE · doi:10.1371/journal.pone.0035185 · Cited by 173 · see citing works
Self-citationWatt, J. A., Goodarzi, Z., Veroniki, A. A., Nincic, V., Khan, P. A., Ghassemi, M., Thompson, Y., Tricco, A. C., & Straus, S. E. (2019) · Annals of Internal Medicine · doi:10.7326/m19-0993 · Cited by 159 · see citing works
Livingston, G., Barber, J., Marston, L., Rapaport, P., Livingston, D., Cousins, S., Robertson, S., La Frenais, F., & Cooper, C. (2017) · BJPsych Open · doi:10.1192/bjpo.bp.117.005181 · Cited by 148 · see citing works
Psychotropic drug prescriptions in western European nursing homes
Janus, S. I. M., van Manen, J. G., IJzerman, M. J., & Zuidema, S. U. (2016) · International Psychogeriatrics · doi:10.1017/s1041610216001150 · Cited by 110 · see citing works
Natural Phytochemicals in the Treatment and Prevention of Dementia: An Overview
Libro, R., Giacoppo, S., Soundara Rajan, T., Bramanti, P., & Mazzon, E. (2016) · Molecules · doi:10.3390/molecules21040518 · Cited by 107 · see citing works
What should we know about dementia in the 21st Century? A Delphi consensus study
Annear, M. J., Toye, C., McInerney, F., Eccleston, C., Tranter, B., Elliott, K.-E., & Robinson, A. (2015) · BMC Geriatrics · doi:10.1186/s12877-015-0008-1 · Cited by 58 · see citing works
Fraker, J., Kales, H. C., Blazek, M., Kavanagh, J., & Gitlin, L. N. (2014) · Occupational Therapy In Health Care · doi:10.3109/07380577.2013.867468 · Cited by 33 · see citing works
Panca, M., Livingston, G., Barber, J., Cooper, C., La Frenais, F., Marston, L., Cousins, S., & Hunter, R. M. (2019) · PLOS ONE · doi:10.1371/journal.pone.0211953 · Cited by 29 · see citing works
The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial
Pickering, G., Kastler, A., Macian, N., Pereira, B., Valabregue, R., Lehericy, S., Boyer, L., Dubray, C., & Jean, B. (2015) · Drug Design, Development and Therapy · doi:10.2147/dddt.s81004 · Cited by 22 · see citing works
Brexpiprazole for the Treatment of Agitation and Aggression in Alzheimer Disease
Ballard, C. (2023) · JAMA Neurology · doi:10.1001/jamaneurol.2023.3967 · Cited by 14 · see citing works
Self-citation
- Authors
- Husebo, B. S., Ballard, C., Sandvik, R., Nilsen, O. B., & Aarsland, D.
- Affiliations
- University of Bergen (NO)
- King's College London (GB)
- Stavanger University Hospital (NO)
- University of Oslo (NO)
- Corresponding author
- Ballard, C.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2011-07-15
- Volume
- 343
- Issue
- jul15 1
- Pages
- d4065-d4065
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC3137923
- OpenAlex
- W2093639349
- Cited by
- 571
- References
- 33
- Citations by year
- 2026: 20 · 2025: 23 · 2024: 14 · 2023: 18 · 2022: 62 · 2021: 31 · 2020: 66 · 2019: 45 · 2018: 41 · 2017: 45 · 2016: 41 · 2015: 45 · 2014: 39 · 2013: 28 · 2012: 37
- FWCI
- 51.89
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Portal (King's College London) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Universitetet i Bergen (09/1568, 189439)
- Norges Forskningsråd (189439)
- Topics
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Health Sciences › Health Professions › General Health Professions › Geriatric Care and Nursing Homes
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Keywords
- pain management, dementia, agitation, behavioral problems, nursing home residents, paracetamol, morphine, pregabalin, neuropsychiatric symptoms, psychotropic prescribing, activities of daily living, cognition
- MeSH terms
- Aged, Aged, 80 and over, Analgesics, Analysis of Variance, Clinical Protocols, Dementia, Female, Homes for the Aged, Humans, Male, Nursing Homes, Pain, Psychomotor Agitation, Cluster Analysis, Treatment Outcome
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.
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.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
