EXpain Trial - Exercise an a Non-pharmacological Pain-relieving Treatm

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

RecruitingNot a drug-phase studyMS (type not specified)NCT07342777

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Progressive resistance exercise
  • Usual Care followed by progressive resistance exercise

What it measured

Main measures

  • 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.

    Pain

Other measures (25)

  • 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.

    PainMood and sleep

  • 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.

    Pain

  • 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.

    Pain

  • 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.

    Physical function

  • 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.

    Mood and sleep

  • 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.

    Myelin repairMood and sleep

  • 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.

    Walking and mobility

  • 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.

    Thinking and memoryFatigue

  • 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.

    Quality of life (reported by participants)

  • 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.

    Pain

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

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).

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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).

Papers

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History

    1. Started

      Jan 2026

    2. Main results due

      Jul 2028

    3. Finished

      Aug 2028

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