Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM)
Conditions
Keywords
Manual Therapy, Physiotherapy, Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS), RNAseq, microRNA, mechanomiR
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.
Interventions
PROCEDUREManual Therapy
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Sponsors
Fundación Universidad Católica de Valencia San Vicente Mártir
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Outcome measures will be randomized and anonymized
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue score | 8 weeks | MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue |
| Pain index | 8 weeks | FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, \<39 mild, 39-58 moderate, ≥59 severe |
| Differential gene expression | 8 weeks | RNAseq |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | 8 weeks | SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health |
| ANS (autonomic nervous system) dysfunction | 8 weeks | Plantar pressure maps |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective response to treatment | 8 weeks | Custom-made questionnaire, -1 to +1 scale (ítems 1-5), scale 1-10 (item 6), 6 items total, higher scores indicate improvement of symptoms |
Countries
Spain
Outcome results
None listed