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66 active trials for Musculoskeletal Pain

Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?

The study investigates both the effects and the experienced value of the mobile application, MIRA, which is a combination of an electronic diary, a dialogue tool and a decision support tool. The individual user registers real-time data reported in a mobile application, e.g. pain, sleep, mood, social activities, work-related activities, based on the goals and condition of the individual user. In this study, users are citizens participating in vocational rehabilitation due to long term sick leave. The purpose of MIRA is to support a positive and trustful relationship between the citizen and the professional, and to enhance user involvement and shared decision making in the course of rehabilitation. This happens through promotion of the citizens knowledge and understanding of their own health condition and increase his or her self-efficacy, i.e. their ability to cope with their health condition at work and in everyday life. The study uses a combination of quantitative and qualitative methods, analysed both individually and in combination, where findings of the different methods are combined to provide a deeper understanding of the positive and negative effects of using MIRA in vocational rehabilitation. In this way the study investigates both the effect of applying a digital tool, such as MIRA, on a number of quantifiable measures (using questionnaires), and at the same time the study explores what works for whom and why using qualitative and combined methods. In this way, the study aims to contribute with knowledge in a balanced manner, regarding the pros and cons of using digital tools with real-time self-reported data in rehabilitation. The study aim will be fulfilled through the following sub-purposes: To investigate the effect of using MIRA in a course of vocational rehabilitation in relation to the citizens' self-efficacy for pain and work and their experience of shared decision-making in the course of rehabilitation. To investigate the citizens' experience with and perception of using a digital tool like MIRA in their course of rehabilitation. To investigate the professionals' experience with and perception of using a digital tool like MIRA in the course of rehabilitation. To investigate the mechanisms of effect of MIRA (i.e. what works for whom and why), through and integrated analysis of the findings of sub-purpose 1-3.

Start: January 2021
Patient-Centred Innovations for Persons With Multimorbidity - Ontario

The aim of Patient-Centred Innovations for Persons With Multimorbidity (PACE in MM) study is to reorient the health care system from a single disease focus to a multimorbidity focus; centre on not only disease but also the patient in context; and realign the health care system from separate silos to coordinated collaborations in care. PACE in MM will propose multifaceted innovations in Chronic Disease Prevention and Management (CDPM) that will be grounded in current realities (i.e. Chronic Care Models including Self-Management Programs), that are linked to Primary Care (PC) reform efforts. The study will build on this firm foundation, will design and test promising innovations and will achieve transformation by creating structures to sustain relationships among researchers, decision-makers, practitioners, and patients. The Team will conduct inter-jurisdictional comparisons and is mainly a Quebec (QC) - Ontario (ON) collaboration with participation from 4 other provinces: British Columbia (BC); Manitoba (MB); Nova Scotia (NS); and New Brunswick (NB). The Team's objectives are: 1) to identify factors responsible for success or failure of current CDPM programs linked to the PC reform, by conducting a realist synthesis of their quantitative and qualitative evaluations; 2) to transform consenting CDPM programs identified in Objective 1, by aligning them to promising interventions on patient-centred care for multimorbidity patients, and to test these new innovations' in at least two jurisdictions and compare among jurisdictions; and 3) to foster the scaling-up of innovations informed by Objective 1 and tested/proven in Objective 2, and to conduct research on different approaches to scaling-up. This registration for Clinical Trials only pertains to Objective 2 of the study.

Start: January 2016
Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care

Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain. The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective? WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis. Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs). The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work. Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.

Start: December 2020
Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans

Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being. Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics. To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment. Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes. 178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only. Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care. Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments. This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention. Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up. The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes. Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning. The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement. Participants will include up to 40 patients who were treated with Brief CBT-CP. Participants will be interviewed about key components of the treatment and their perception of effectiveness. Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement. Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.

Start: October 2021
Targeted Physiotherapeutic Treatment for Aromatase Inhibitor-associated Musculoskeletal Pain in Breast Cancer Survivors

The primary objective of this trial is to assess the efficacy of targeted individualised physiotherapeutic treatment on aromatase inhibitor-associated musculoskeletal pain. This trial asks a critical, previously unaddressed, question of clinical importance about management of musculoskeletal (MSK) pain secondary to aromatase inhibitor (AI) treatment of hormone receptor-positive breast cancer. Many breast cancer survivors taking AIs experience muscle and/or joint pain, which may cause many to stop taking AIs and may inhibit exercise or physical activity, despite its known health benefits. Physiotherapeutic treatment is considered a standard management strategy for many MSK pain conditions, in which targeted specific exercise therapy is now as an evidence-based management strategy with proven effectiveness and patient satisfaction. Thus, referral to physiotherapy would be a natural strategy in women who experience MSK pain as an adverse effect to AI therapy. However, it is unclear if physiotherapeutic treatment has similar effects on AI induced MSK pain as in primary MSK pain. Two systematic review (one with a meta-analysis) have assessed the effect of different pain management strategies for AI-induced MSK-pain and found great uncertainty in the effects of exercise, relaxation techniques and acupuncture. They also found limited evidence on the subject and moderate to low quality of the studies included. The evidence on the subject is clearly limited but the need for a treatment option to minimize the side-effects of the AI medication real and necessary. Targeted individualised physiotherapeutic treatment is tailored for the affected (painful) tissue/joint/region specifically and is based on extensive experience and evidence from MSK physiotherapy in rheumatic and orthopedic patient population. Targeted individualised physiotherapy treatment take into account the individual patient, her constitution, the painful tissue/region/joint (e.g. its biomechanics, physiological properties, and inflammatory activity), and is adjusted according to day-to-day variations in pain and progressed based on the interaction between changes in symptoms and function and tissue healing. Such approach is expected to yield a greater effect on MSK pain, than a generic exercise program. Further, targeted treatment programs are delivered by trained physiotherapists, who have specific clinical training and experience in clinical management of patient and handling MSK pain, which is also expected to yield better clinical outcomes than programs delivered by people without clinical training. Altogether it is very likely that a targeted physiotherapy treatment will be of significant benefit to breast cancer survivors with AI induced MSK pain. The aim is to compare targeted individualized physiotherapeutic treatment and medical care with medical care alone on aromatase inhibitor associated musculoskeletal pain in female breast cancer survivors. It is hypothesized that targeted physiotherapeutic treatment and medical care reduces musculoskeletal pain significantly in women with aromatase inhibitor associated musculoskeletal pain when compared to medical care alone. The plan is to include 120 participants from the oncology department at Rigshospitalet, Denmark. Participants will partake in the study for a total of 26 weeks. During the first 12 week the intervention group will receive the physiotherapeutic treatment twice a week. The medical care visits are place at the first visit to the clinic, week 13 and week 26.

Start: October 2020