Facet-joint injections for people with persistent non-specific low back pain (FIS) : study protocol for a randomised controlled feasibility trial

BACKGROUND: The role of injections of therapeutic substances into the back as treatment for low back pain is unclear. Facet joint injections are widely used despite the absence of evidence of sustained benefit. We hypothesise that facet joint injections might facilitate engagement with physiotherapist-led, best usual care (a combined physical and psychological programme) and is a clinically and cost-effective treatment for people with suspected low back pain of facet joint origin. METHODS/DESIGN: We present here the protocol for a randomised controlled feasibility trial for a main trial to test the above hypotheses. Patients referred to secondary care with persistent non-specific low back pain will be screened and invited to take part in the study. Those who meet the eligibility criteria will be invited for a physiotherapy assessment to confirm trial eligibility and for baseline data collection. All participants (n = 150) will be offered the best usual care package with physical and psychological components. Those randomised into the intervention arm (n = 75) will, in addition, receive intra-articular facet joint injections with local anaesthetic and steroids. Primary outcome data will be collected using daily and then weekly text messaging service for a pain score on a 0-10 scale. Questionnaire follow-up will be at 3, 6, and 12 months. Evaluation of trial processes and health economic analyses, including a value of information analysis, will be undertaken. The process evaluation will be mixed methods and will include the views of all stakeholders. DISCUSSION: Whilst this trial is a feasibility study it is currently one of the largest trials in this area. The outcomes will provide some evidence on the use of facet joint injections for patients with clinically diagnosed facet joint pain. TRIAL REGISTRATION: EudraCT identifier 2014-000682-50

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

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

Reducing opioid use for chronic pain with a group-based intervention

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: ISRCTN4947093

A systematic review of the impact of patient and public involvement on service users, researchers and communities

Objective Patient and public involvement (PPI) in research has expanded nationally and internationally over the last decade, and recently there has been significant attention given to understanding its impact on research. Less attention has been given to the impact of PPI on the people involved, yet it has been shown that the success of PPI in research can be reliant on the processes of engagement between these individuals and communities. This paper therefore critically explores the impact of PPI on service users, researchers and communities involved in health and social care research. Data Sources Searches were undertaken from 1995 to April 2012 in the electronic databases MEDLINE, EMBASE, PsycINFO, Cochrane library, CINAHL, HMIC and HELMIS. Searches were undertaken for grey literature using the databases InvoNet and NHS Evidence. Study Selection Studies were included if they included the impact of PPI on individual service users, researchers or communities under research. Studies were excluded if they were in a foreign language (unless they were deemed critical to the systematic review) or were in children and adolescent services. Study Appraisal Data were extracted using a narrative synthesis, and quality was assessed using the Critical Appraisal Skills Programme. Main Results Service users reported feeling empowered and valued, gaining confidence and life skills. Researchers developed a greater understanding and insight into their research area, gaining respect and a good rapport with the community. The community involved in research became more aware and knowledgeable about their condition. However, lack of preparation and training led some service users to feel unable to contribute to the research, while other service users and communities reported feeling overburdened with the work involved. Researchers reported difficulties in incorporating PPI in meaningful ways due to lack of money and time. Conclusion This is the first international systematic review to focus on the impact of PPI on the people involved in the process. The beneficial and challenging impacts reported highlight the importance of optimising the context and processes of involvement, so creating the potential for PPI to impact positively on the research itself

Design and development of a decision support package for low back pain

Objective. To develop a decision support package for people with low back pain (LBP) referred for physiotherapy. Methods. We used a program of exploratory work, including literature reviews, a Delphi study, a nominal group with physiotherapists, focus groups with patients, and secondary analysis of existing interview data. Results. We developed an information booklet describing the evidence-based treatment modalities available in a physiotherapy department. This includes data on likely benefits and risks and how the intervention is delivered. The booklet specifically addresses questions identified as important in our exploratory work. Space is provided for patients to note down the pros and cons of each treatment and what matters to them when choosing treatments. The patient is subsequently directed to a section that explores any gaps in knowledge, values, support, and choice before finally clarifying if a treatment decision is possible. At this stage they are encouraged to note down any questions or concerns they have to be discussed at the first physiotherapy consultation. This overall package includes patient material in the form of a booklet posted prior to their consultation, plus the enhanced consultation with the specially trained physiotherapist. Patients then receive their chosen treatment. In addition we developed a training package for physiotherapists that explains the content of the booklet and supports them in using informed, shared decision making in their consultation. Conclusion. This package has the potential to improve effectiveness of treatments and patient satisfaction for LBP by facilitating patient choice and therefore matching patients more effectively to different treatments

Correction: Study protocol: Improving patient choice in treating Low back pain (IMPACT - LBP): A randomised controlled trial of a decision support package for use in physical therapy

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.After publication of this protocol a change in study design was needed [1]. Due to changes in the service configuration in the host physiotherapy department individual randomisation as originally planned could not be implemented. It was necessary to change to cluster randomisation with the unit of randomisation being the treating physiotherapist. Potential participants are given outpatient appointments by booking staff unaware of the physiotherapist’s randomisation. Trial recruitment is also done blind to physiotherapist allocation. In this manner we have ensured allocation concealment prior to participants joining the study. Cluster randomised trials need to inflate their sample size to account for clustering. Typically primary care trials use an intra-cluster correlation coefficient (ICC) of 0.05 in this calculation [2]. Our past experience is that clustering effects by therapist in trials of this nature may be very small [3]. To account for this we developed a provisional revised sample size using an ICC of 0.05 and did an interim analysis of pooled data, just for ICC of the primary outcome, after the first 40 participants had completed the three month follow-up questionnaire. The ICC was close to zero, suggesting that using an ICC of 0.05 was too conservative. We therefore assumed an ICC of 0.01 to estimate the design effect due to clustering. Based on an average cluster size of nine this results in a revised final sample size of 158

Additional file 2: of Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial

SPIRIT_checklist. (DOCX 48 kb