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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Change 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.
  Subjective average pain severity over the past 7 days measured using a Numerical Rating Scale from 0 to 10 (NRS0-10)

Trial sites (1)

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