Clinical trial NCT04174300: Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)
Official title: Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia (FM)
Chronic Fatigue Syndrome (CFS)
Keywords: Manual Therapy
Physiotherapy
Fibromyalgia (FM)
Chronic Fatigue Syndrome (CFS)
RNAseq
microRNA
mechanomiR
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue score
timeFrame: 8 weeks
measure: Pain index
timeFrame: 8 weeks
measure: Differential gene expression
timeFrame: 8 weeks
Secondary outcomes:
measure: Quality of life score
timeFrame: 8 weeks
measure: ANS (autonomic nervous system) dysfunction
timeFrame: 8 weeks
Other outcomes:
measure: Subjective response to treatment
timeFrame: 8 weeks
Locations:
city: Valencia
country: Spain
facility: Clinicas Universitarias UCV
Study officials:
affiliation: Catholic University of Valencia
name: Maria Garcia-Escudero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Valencia
name: Elisa Oltra, PhD
role: STUDY_CHAIR
References:
citation: 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.