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

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Completed

Conditions: Fibromyalgia (FM); Chronic Fatigue Syndrome (CFS)

Treatments: Procedure: Manual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04174300

UCV/2018-2019/076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Manual Therapy

Experimental group

Description:

8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Treatment:

Procedure: Manual Therapy