Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis (MPIMS).

NCT07741864 | Not Yet Recruiting

• 1 other identifier: SICEIA-2025-002466
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether a mindfulness-based intervention is effective for reducing pain in adults with multiple sclerosis. It will also assess whether this intervention improves other symptoms commonly associated with pain, such as fatigue, sleep disturbances, anxiety, depression, and quality of life. The main questions it aims to answer are:

• Does a mindfulness-based intervention reduce pain intensity in people with multiple sclerosis?
• Does the intervention improve fatigue, sleep quality, emotional well-being, quality of life?
• Does the effectiveness of the intervention differ according to the type of pain experienced by participants? Researchers will compare a mindfulness-based intervention with an educational program to determine whether mindfulness provides additional benefits for pain management in people with multiple sclerosis. Participants will:
• Be randomly assigned to either the mindfulness intervention group or the educational control group.
• Complete assessments before the intervention, immediately after the intervention, and at 1-month and 3-month follow-up visits.
• If assigned to the mindfulness group, attend eight weekly 2.5-hour group sessions plus one 6-hour retreat, either in person or online.
• If assigned to the control group, attend two 2-hour educational sessions during the study period.
• Complete questionnaires evaluating pain, fatigue, physical function, anxiety, depression, sleep quality, quality of life, and mindfulness throughout the study.

Conditions

Multiple Sclerosis; Pain Management; Pain

Keywords

Multiple Sclerosis; Pain; Mindfulness

Outcome Measures

Primary Outcomes (6)

• Intensity of pain

  The intensity of pain will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported measure of pain intensity in which participants rate their current pain on an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Dimensions of pain

  The dimensions of pain will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The SF-MPQ is a 15-item instrument that assesses the qualitative characteristics of pain through 11 sensory and 4 affective descriptors, each rated on a 4-point scale from 0 (none) to 3 (severe). Total score ranges from 0 to 45, with higher scores indicating greater pain intensity and more severe pain qualities.

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Impact of pain on daily functioning

  The impact of pain on daily functioning will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ). The PSEQ is a 10-item questionnaire designed to evaluate an individual's confidence in performing daily activities despite pain. Each item is rated on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely confident), yielding a total score from 0 to 60, with higher scores indicating greater pain self-efficacy.

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Presence of neuropathic pain

  The presence of neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire. The DN4 is a 10-item questionnaire consisting of 7 interview items assessing symptoms characteristic of neuropathic pain and 3 clinical examination items evaluating hypoesthesia to touch, hypoesthesia to pinprick, and pain evoked by brushing. Each item is scored as 0 (absent) or 1 (present), yielding a total score ranging from 0 to 10. A total score of ≥4 is indicative of neuropathic pain.

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Emotional and cognitive impact of pain

  The emotional and cognitive impact of pain will be assessed using the Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-administered questionnaire that assesses pain catastrophizing by evaluating negative thoughts and emotional responses associated with pain. It comprises three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time), yielding a total score ranging from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Severity of pain

  The severity of pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self-report questionnaire that assesses pain severity, pain interference with daily activities, and pain characteristics. It consists of 9 items. Pain severity is assessed using four items rated on an 11-point numeric rating scale (0 = "no pain" to 10 = "pain as bad as you can imagine"), while pain interference is assessed using seven items rated from 0 ("does not interfere") to 10 ("completely interferes"). Higher scores indicate greater pain severity.

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

Secondary Outcomes (9)

• Physical function

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Fatigue

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Depressive symptoms

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Anxiety

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

• Sleep disturbance

  Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.

Study Arms (2)

Mindfulness Group

EXPERIMENTAL

Participants will receive a Mindfulness intervention specifically designed for pain management in people with multiple sclerosis.

Other: Mindfulness-based intervention

Educational Group

ACTIVE COMPARATOR

Participants will receive an active educational intervention for pain management consisting of two group sessions

Other: Educational intervention

Interventions

Mindfulness-based intervention OTHER

Group-based mindfulness intervention specifically designed for pain management in people with multiple sclerosis. The program includes pain neuroscience education, cognitive pain management strategies, guided meditation, active visualization techniques, mindfulness-based stretching exercises, and mindful yoga.The intervention consists of eight weekly group sessions lasting 2.5 hours each, followed by a 6-hour mindfulness retreat. Participants may attend the sessions either in person or online.

Mindfulness Group

Educational intervention OTHER

Educational intervention consists of two 2-hour group sessions on multiple sclerosis and pain management, delivered once every 4 weeks during the 8-week intervention period.

Educational Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years.
• Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 1.0 and 7.0.
• Presence of pain.
• Ability to provide written informed consent.

You may not qualify if:

• Severe cognitive impairment.
• Diagnosed psychiatric disorders (e.g., schizophrenia or personality disorders).
• Participation in another non-pharmacological intervention specifically aimed at pain management.
• If receiving stable pain medication, treatment must have been maintained for at least 4 months before enrollment.
• Unwillingness to provide informed consent.

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Hopsital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

Related Publications (24)

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MeSH Terms

Conditions

Multiple Sclerosis; Pain; Agnosia

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Eleonora Magni, MSc

CONTACT

622623602; magni@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist and MSc

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: August 3, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)