Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)

Study Overview
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Brief Summary
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Fibromyalgia (FM)and Chronic Fatigue Syndrome (CFS) are complex diseases often presenting overlapping symptomatology. Manual therapy (MT) protocols report benefits for pain treatment of FM, but the underlying mechanisms for patient improvement remain unknown. The main goal of this study is to assess the molecular changes associating to mechanical and additional MT triggers, possibly involved in patient symptom improvement.

Detailed Description
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Patients with Fibromyalgia as primary diagnosis assessed by the 1990 & 2010 ACR (American College of Rheumatology) criteria, presenting or not comorbid CFS, according to the Canadian and International CFS criteria, age 40-75 and BMI<35 (N=40), will be subjected to physiotherapy treatment consisting on 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N by a single operator (Collegiate Physiotherapist). Blood samples (10-20mls/participant) will be obtained before and after first treatment, and after fourth and last treatment to determine molecular blood changes associated to the physiotherapy protocol applied. PBMC (Peripheral Blood Molecular Cells) transcriptome before and after treatments (RNAseq) will be studied towards identifying treatment-associated differential expression, mechanomiR profiles included. Patient health status with treatment will be monitored by FIQ, MFI and SF-36 questionnaires, in addition to an anonymized satisfaction questionnaire to register potential undesired secondary effects.

Official Title
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Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)

Conditions
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Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS)

Intervention / Treatment
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* Procedure: Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of FM with or without comorbid CFS Not receiving hormone therapy Not suffering from other diseases Without previous history of cancer Not actively participating in any pharmacological trial Not taking medication for at least 12 hours before blood draw Having signed informed consent Exclusion Criteria: - Any uncompliance with what is described as inclusion criteria

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy<br>8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N | Procedure: Manual Therapy<br>* 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N<br>* Other names: Physiotherapy treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue score | MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue | 8 weeks | 
| Pain index | FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, ≥59 severe | 8 weeks | 
| Differential gene expression | RNAseq | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health | 8 weeks | 
| ANS (autonomic nervous system) dysfunction | Plantar pressure maps | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual Therapy, Physiotherapy, Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS), RNAseq, microRNA, mechanomiR