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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome (CFS); Fibromyalgia (FM)
• Intervention / Treatment: Procedure: Manual Therapy

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46001
    • Clinicas Universitarias UCV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manual Therapy; 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N	Procedure: Manual Therapy; 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N; Other Names: Physiotherapy treatment

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective response to treatment	Custom-made questionnaire, -1 to +1 scale (ítems 1-5), scale 1-10 (item 6), 6 items total, higher scores indicate improvement of symptoms	8 weeks

Collaborators and Investigators

• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
• Investigators: Principal Investigator: Maria Garcia-Escudero, PhD, Catholic University of Valencia; Study Chair: Elisa Oltra, PhD, Catholic University of Valencia

Publications and helpful links

General Publications

• Espejo JA, Garcia-Escudero M, Oltra E. Unraveling the Molecular Determinants of Manual Therapy: An Approach to Integrative Therapeutics for the Treatment of Fibromyalgia and Chronic Fatigue Syndrome/Myalgic Encephalomyelitis. Int J Mol Sci. 2018 Sep 9;19(9):2673. doi: 10.3390/ijms19092673.

Helpful Links

• UCV Physiotherapy Research Group

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2019
• Primary Completion (ACTUAL): March 10, 2020
• Study Completion (ACTUAL): March 10, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (ACTUAL): November 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: microRNA; Physiotherapy; RNAseq; Manual Therapy; Chronic Fatigue Syndrome (CFS); Fibromyalgia (FM); mechanomiR
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fibromyalgia; Myofascial Pain Syndromes; Fatigue Syndrome, Chronic
• Other Study ID Numbers: UCV/2018-2019/076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No