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

Sponsor
University of Aarhus
Study ID
NCT07342777
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Progressive resistance exercise — OTHER
    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 — OTHER
    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 Details

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).

Key Dates

First listed
Jan 15, 2026
Start date
Jan 15, 2026
Status verified
Aug 2025
Primary completion
Jul 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Resistance exercise group
    Participants must have chronic pain (NRS ≥ 3) when enrolled and furthermore meet eligibility criteria. Intervention: 12 weeks of progressive resistance exercise followed by 12 weeks of usual care
  • Experimental: Waitlist group
    Participants must have chronic pain (NRS ≥ 3) when enrolled and furthermore meet additional eligibility criteria. Intervention: 24 weeks of usual care followed by 12 weeks of progressive resistance exercise.

Primary Outcome Measure

Change in pain severity [ Time Frame: 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. ]

Central Contacts

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