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

Not Applicable

Completed

• Conditions: Fibromyalgia (FM); Chronic Fatigue Syndrome (CFS)
• Interventions: Procedure: Manual Therapy

• Registration Number: NCT04174300
• Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-03-20
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manual Therapy	Manual Therapy	8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinicas Universitarias UCV; 🇪🇸 Valencia, Spain