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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2020-03-10

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.

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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.

Conditions

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Fibromyalgia (FM) Chronic Fatigue Syndrome (CFS)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Outcome measures will be randomized and anonymized

Study Groups

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Manual Therapy

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

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type PROCEDURE

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

Interventions

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Manual Therapy

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

Intervention Type PROCEDURE

Other Intervention Names

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Physiotherapy treatment

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No