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

Abstract

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.

Fig 1

Flow chart showing patients flow through the 12-week study period including control and intervention groups.

Fig 2

MOBID-2 Pain Scale total score with mean and standard error of the mean by control and treatment group over study period in total study sample.

Fig 3

Mean and standard error of the mean in musculoskeletal pain (MOBID-2 Pain Scale part 1) scores by control and intervention groups over study period.

Fig 4

Mean and standard error of the mean in pain related to internal organs, head and skin (MOBID-2 Pain Scale part 2) by control and intervention groups over study period.

Fig 5

MOBID-2 Pain Scale total score with mean and standard error of the mean, ordered by different analgesics (acetaminophen, extended release morphine and buprenorphine transdermal patch and pregabalin) and control group over study period.

Fig 6

Activity of daily living total score with mean and standard error of the mean, in order to different analgesics (acetaminophen, extended release morphine and buprenorphine transdermal patch and pregabalin) and control groups over study period.