Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial

Abstract

Importance: Opioid use for chronic nonmalignant pain can be harmful.

Objective: To test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care.

Design, setting, and participants: Multicentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020.

Intervention: Participants were randomized 1:1 to either usual care or 3-day-long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months.

Main outcomes and measures: The 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report.

Results: Of 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (-4.1 in the intervention and -3.17 in the usual care groups; between-group difference: mean difference, -0.52 [95% CI, -1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001). Serious adverse events occurred in 8% (25/305) of the participants in the intervention group and 5% (16/303) of the participants in the usual care group. The most common serious adverse events were gastrointestinal (2% in the intervention group and 0% in the usual care group) and locomotor/musculoskeletal (2% in the intervention group and 1% in the usual care group). Four people (1%) in the intervention group received additional medical care for possible or probable symptoms of opioid withdrawal (shortness of breath, hot flushes, fever and pain, small intestinal bleed, and an overdose suicide attempt).

Conclusions and relevance: In people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities.

Trial registration: isrctn.org Identifier: ISRCTN49470934.

Figure 1.. Participant Selection, Randomization, and Follow-up in the I-WOTCH Trial

GP indicates general practitioner; I-WOTCH, Improving the Wellbeing of People With Opioid Treated Chronic Pain; and PROMIS-PI-SF-8a, Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a. ^aNine self-referrals and 5 secondary care referrals. ^bGeneral practitioner practice felt it inappropriate to approach. Reasons included malignant pain, short life expectancy, care home resident/housebound, severe mental illness, and active cancer causing pain. ^cOne person listed both reasons. ^dRandomization stratified by geographic locality, baseline pain severity (low/high), and baseline morphine equivalent dose of opioids. Two self-referrals and 2 secondary care referrals. ^eSee eTable 11 in Supplement 2 for follow-up rates and availability of secondary outcomes at 4 and 8 months. See eTables 10 and 12 through 14 in Supplement 2 for information on withdrawals. ^fOpioid use calculated as morphine equivalent dose per day in the four weeks prior to 12-month follow-up.

Figure 2.. Pain Interference and Morphine Equivalent Dose Opioid Use Scores at Baseline and 12 Months

The parallel line plots (A and C) contain a line for each participant in the study with baseline and 12-month data available. Each line starts at the baseline value (circle) and extends along the line to the 12-month value. Panel C shows the Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) standardized T score (range, 40.7-77), with higher scores signifying higher pain interference in daily life (see footnote g in Table 1 for information on PROMIS-PI-SF-8A scoring and ranges). Panel A shows the daily morphine equivalent dose (continuous value) used in the previous 4 weeks from the time point. Panels B and D show the corresponding box and whisker plots, with lines and boxes indicating medians and IQRs, whiskers indicating 1.5 × the IQR, and dots representing more extreme data.