RECRUITINGINTERVENTIONAL

EXpain Trial - Exercise an a Non-pharmacological Pain-relieving Treatment in People With Multiple Sclerosis

EXpain - Is Exercise an Effective Non-pharmacological Analgesic Treatment in People With Multiple Sclerosis?

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion criteria: 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. Exclusion Criteria: 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).

Treatments Being Tested

OTHER

Progressive resistance exercise

Participants assigned to this arm will undergo 12 weeks of progressive heavy-load resistance exercise, with 5 sessions over a 2-week period (equaling a total of 30 sessions). Each session will commence with a 5-minute warm-up using a bicycle ergometer. The training program will consist of machine-based exercises, including leg press, knee extensions, hamstring curls, seated calf raises, chest press, and lateral pull-down. Progression will be ensured through an increase in the number of sets (from 3 to 4, interspersed by 1-2 minutes of rest) for each exercise along with an increment in intensity (from 15 Repetition Maximum (RM) towards 8RM.

OTHER

Usual Care followed by progressive resistance exercise

Participants assigned to this arm will undergo 24 weeks of waitlist control. The control group will continue their habitual lifestyle and usual care throughout the whole period. After 24 weeks, the waitlist control group will undergo the same progressive resistance exercise regimen as described in the intervention group.

Locations (1)

Aarhus University

Aarhus, Denmark, Denmark