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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Therapy | Experimental | 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Therapy | Procedure | 8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective response to treatment | Custom-made questionnaire, -1 to +1 scale (Ãtems 1-5), scale 1-10 (item 6), 6 items total, higher scores indicate improvement of symptoms | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
- Any uncompliance with what is described as inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Maria Garcia-Escudero, PhD | Catholic University of Valencia | Principal Investigator |
| Elisa Oltra, PhD | Catholic University of Valencia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinicas Universitarias UCV | Valencia | 46001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30205597 | Background | 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. |
| Label | URL |
|---|---|
| UCV Physiotherapy Research Group | View source |
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There is not a plan to make IPD available.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Outcome measures will be randomized and anonymized
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| 8 weeks |
| D009422 |
| Nervous System Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |