Longitudinal Analysis of an Innovative Non-Pharmacological Intervention for Chronic Pain in a Marginalized Population: A Prospective Pilot Study of myoActivation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- PEG score wk 4
研究概览
简要总结
Marginalized populations are at increased risk of chronic pain, trauma and use of street drugs to manage this suffering, with the associated risk of overdoses. Non-pharmacological options to manage chronic pain are difficult for this population to access. myoActivation® is an innovative structured assessment and therapeutic approach. This study will be conducted in the Vancouver Community Pain Service and will will examine the impact of this treatment on pain outcomes, function and quality of life.
详细描述
Purpose: This study will evaluate the inclusion of myoActivation in primary care for marginalized persons with concurrent opioid use disorder (OUD), chronic pain and trauma history. The research aims to investigate whether myoActivation improves pain intensity, quality of life, physical function, and reduces the need for prescribed analgesics (including opioids) and reported illicit drug use.
Hypothesis: The investigators hypothesize that patients with chronic pain who are treated with myoActivation will experience a reduction in pain and improvement in function and quality of life as shown by a 30% reduction on the PEG score (Pain intensity, interference with Enjoyment of life, interference with General activity) at 4, 12 and 24 weeks.
Justification: Chronic pain is typically treated by prescription of analgesic medications, including opioids. However, many patients who have overdoses are using opioids and other substances (including street drugs, alcohol, and marijuana) to manage chronic pain. There are an inadequate number of effective non-pharmacological options to manage chronic pain and wait lists for local Vancouver chronic pain clinics are as long as a year. Other treatment modalities offered by the Vancouver Community pain service include physiotherapy and counselling.
Objectives: The investigators aim to demonstrate an improvement in pain intensity, quality of life, and physical function as the primary outcomes. Secondary objectives include reduced need for analgesic medications (including opioids) and illicit drug use.
Research Design: This study is a prospective, mixed method design, including 1:1 semi-structured patient interviews. It is an observational study: patients will NOT be allocated to treatment on the basis of randomization or their enrollment in the study, i.e. participants will receive routine clinical care, based on the services offered by the clinical team at the pain clinic, and this will not change with their participation in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any English-speaking patient with myofascial related chronic pain lasting >3 months, referred to the Vancouver Community (VC) chronic pain service by primary care.
排除标准
- •Any patient who has received any of the following pain interventions or treatment in the 3 months preceding recruitment/intake to the pain service:
- •Intramuscular Stimulation (IMS);
- •Trigger Point Injection (TPI) with or without injectate;
- •External physiotherapy (i.e. outside the service offered at VC pain clinic);
- •Joint injection;
- •Chiropractic;
- •Acupuncture;
- •Group counselling at VC Pain Service (or has an existing appointment to attend Group counselling).
- •(note, exclusion list does not include pain medications or opioid replacement therapy; also note, patients who subsequently access the VC Pain Service Group counselling will continue to be included in the study)
结局指标
主要结局
PEG score wk 4
时间窗: 4 weeks
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
PEG score wk 12
时间窗: 12 weeks
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
PEG score wk 24
时间窗: 24 weeks
PEG is a validated self-report measure of (1) Pain intensity, (2) interference with Enjoyment of life, (3) interference with General activity. Each of the 3 dimensions is scored on a 0-10 scale. Total score is the average (mean) of the 3 values, minimum 0, maximum 10, lower score indicates a better outcome.
次要结局
- PCS score wk 4(4 weeks)
- PSEQ score wk 4(4 weeks)
- PCS score wk 12(12 weeks)
- PSEQ score wk 12(12 weeks)
- PSEQ score wk 24(24 weeks)
- Drug use wk 4(4 weeks)
- PCS score wk 24(24 weeks)
- Drug use wk 24(24 weeks)
- Drug use wk 12(12 weeks)
研究者
Barbara Eddy
Associate Member in the UBC Department of Medicine, Division of Palliative Care
University of British Columbia