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Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial


Sandvik, R. K., Selbaek, G., Seifert, R., Aarsland, D., Ballard, C., Corbett, A., Husebo, B. S.


European Journal of Pain, Volume: 18, No.: 10, Pages.: 1490-1500

Year of Publication



Background: Pain is frequent and distressing in people with dementia, but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome. Methods: Three hundred fifty‐two people with dementia and significant agitation from 60 nursing home units were included in this study. These units, representing 18 nursing homes in western Norway, were randomized to a stepwise protocol of treating pain (SPTP) or usual care. The SPTP group received acetaminophen, morphine, buprenorphine transdermal patch and pregabalin for 8 weeks, with a 4‐week washout period. Medications were governed by the SPTP and each participant’s existing prescriptions. We obtained pain intensity scores from 327 patients (intervention n = 164, control n = 163) at five time points assessed by the primary outcome measure, Mobilization‐Observation‐Behaviour‐Intensity‐Dementia‐2 (MOBID‐2) Pain Scale. The secondary outcome was activities of daily living (ADL). We used a linear intercept mixed model in a two‐way repeated measures configuration to assess change over time and between groups. Results: The SPTP conferred significant benefit in MOBID‐2 scores compared with the control group [average treatment effect (ATE) −1.388; p < 0.001] at week 8, and MOBID‐2 scores worsened during the washout period (ATE = −0.701; p = 0.022). Examining different analgesic treatments, benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 (ATE = −0.663; p = 0.010), continuing to increase until week 8 (ATE = −1.297; p < 0.001). Although there were no overall improvements in ADL, an increase was seen in the group receiving acetaminophen (ATE = +1.0; p = 0.022). Conclusion: Pain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function. (PsycINFO Database Record (c) 2014 APA, all rights reserved). (journal abstract)

Bibtex Citation

@article{Sandvik_2014, doi = {10.1002/ejp.523}, url = {}, year = 2014, month = {may}, publisher = {Wiley-Blackwell}, volume = {18}, number = {10}, pages = {1490--1500}, author = {R.K. Sandvik and G. Selbaek and R. Seifert and D. Aarsland and C. Ballard and A. Corbett and B.S. Husebo}, title = {Impact of a stepwise protocol for treating pain on pain intensity in nursing home patients with dementia: A cluster randomized trial}, journal = {{EJP}} }


acetaminophen, and, clinical trials, cluster randomized trial, dementia, drug therapy, intervention, morphine, nursing home patients, nursing homes, of, pain, patch, pregabalin, protocol, sptp, stepwise, transdermal, treating

Countries of Study


Types of Dementia

Dementia (general / unspecified)

Types of Study

Cluster RCT

Type of Outcomes

ADLs/IADLs, Prevention and/or management of co-morbidities


Nursing Homes

Type of Interventions

Non-pharmacological Treatment, Pharmaceutical Interventions

Pharmaceutical Interventions


Non-Pharmaceutical Interventions

Case management / Care navigator