EXpain - Is Exercise an Effective Non-pharmacological Analgesic Treatment in People With Multiple Sclerosis?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in pain severity
研究概览
简要总结
The primary goal of this study is to test whether 12 weeks of progressive resistance exercise is an effective non-pharmacological treatment for reducing pain in people with multiple sclerosis and chronic pain.
The study will be a randomized controlled trial with multiple training sites. After baseline testing, participants will be randomly assigned to either a 12-week progressive resistance exercise intervention followed by a 12-week follow-up period or to a 24-week waitlist control group that receives usual care.
It is hypothesized that people with multiple sclerosis and chronic pain who receive the intervention will experience greater reductions in pain (i.e., clinically relevant reductions) compared to the waitlist control group (primary hypothesis), and that this pain reduction will be preserved after a 12-week follow-up period (secondary hypothesis).
详细描述
Purpose and Hypotheses:
The main purpose of this project is to understand the impact of pain in people with multiple sclerosis, how exercise may affect pain symptoms, and whether these effects depend on the underlying pain mechanisms and/or biopsychosocial factors.
The purpose of the main study (study 2) is to test the hypotheses that:
People with MS receiving 12 weeks of resistance exercise will experience superior average analgesic effects (i.e., clinically relevant reductions), compared with MS controls receiving usual care (primary hypothesis), and this analgesic effect will be preserved after a 12-week follow-up period (secondary hypothesis).
The purpose of studies 1,3, 4, and 5 is to test the hypotheses that:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Average pain levels of >3 on the Numerical Rating Scale from 0-10 (NRS0-10), age ≥ 18 years, a valid MS diagnosis (ICD-10 code: G35), ability to self-transport to test and exercise.
排除标准
- •Pregnancy, Diabetes, neurological or other comorbidities that hinder participation in the study, relapse within the past 2 months, classified as high cardiovascular risk according to the American College of Sports Medicine´s guidelines, and participation in structured exercise over the past 3 months (≥ 2 sessions/week).
结局指标
主要结局
Change in pain severity
时间窗: Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.
Subjective average pain severity over the past 7 days measured using a Numerical Rating Scale from 0 to 10 (NRS0-10)
次要结局
- Change in Brief Pain Inventory (BPI)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Graded Chronic Pain Scale (GCPS-R)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Douleur Neuropathique 4 questions (DN4)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in physical activity (Baecke Habitual Physical Activity Questionnaire)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Hospital Anxiety and Depression Scale (HADS)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Pittsburgh Sleep Quality Index (PSQI)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Multiple Sclerosis Walking Scale-12 (MSWS-12)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Modified Fatigue Impact Scale (MFIS)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in MS-impact Scale-12 (MSIS-29)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in daily fluctuations in pain severity(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in daily fluctuations in fatigue severity(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Clinical Sensory Test (CST)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in pressure Pain Detection Threshold and pressure Pain Tolerance Threshold(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Temporal Summation of Pain (TSP)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Conditioned Pain Modulation (CPM)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Exercise Induced Hypoalgesia (EIH) and EIH-respons associated with a realistic bout of resistance exercise (aprox. 45 min full body workout) as well as a realistic bout of aerobic exercise on a bicycle ergometer (45 min at 70% of HRmax).(Intervention group: Baseline, 12 week post test, 24 weeks follow-up Waitlist group: Baseline, 12 weeks post test, 24 weeks follow-up/baseline, 36 weeks post test.)
- Change in muscle strength of the lower extremities(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in Six Minute Walk Test (6MWT)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Change in 9-Step Stair Ascend (9SSA)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Changes in 5-times Sit-To-Stand (5STS)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Changes in physical activity (Accelerometery)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)
- Changes in C-reactive Protein (CRP)(Intervention group: Baseline, 12 weeks post test Waitlist group: Baseline, 36 weeks post test.)
- Changes in inflammatory biomakers(Intervention group: Baseline, 12 weeks post test Waitlist group: Baseline, 36 weeks post test.)
- Changes in microRNA´s (miRNA's)(Intervention group: Baseline, 12 weeks post test Waitlist group: Baseline, 36 weeks post test.)
- Change in pain distribution (Navigate Pain)(Intervention group: Baseline, 12 weeks post test, 24 weeks follow up test. Waitlist group: Baseline, 12 weeks post test, 24 weeks follow up/ baseline test, 36 weeks post test.)