Effectiveness of a Mindfulness-Based Intervention for Pain Management in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Intensity of pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 to 80 years.
- •Diagnosis of multiple sclerosis with an Expanded Disability Status Scale (EDSS) score between 1.0 and 7.
- •Presence of pain.
- •Ability to provide written informed consent.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Intensity of pain
Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Dimensions of pain
Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Impact of pain on daily functioning
Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Presence of neuropathic pain
Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Emotional and cognitive impact of pain
Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Severity of pain
Time Frame: Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.
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.
Secondary Outcomes
- 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.)
- Health-Related Quality of Life(Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.)
- Mindfulness(Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.)
- Sleep quality(Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.)
- Dispositional mindfulness(Assessments will be performed at baseline, immediately post-intervention, 1 month post-intervention, and 3 months post-intervention.)
Investigators
Eleonora Magni
Physiotherapist and MSc
Hospital Universitario Virgen Macarena