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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Clinicas Universitarias UCV
Valencia, Spain
Fatigue score
MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue
Time frame: 8 weeks
Pain index
FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, \<39 mild, 39-58 moderate, ≥59 severe
Time frame: 8 weeks
Differential gene expression
RNAseq
Time frame: 8 weeks
Quality of life score
SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health
Time frame: 8 weeks
ANS (autonomic nervous system) dysfunction
Plantar pressure maps
Time frame: 8 weeks
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