Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2019
CompletedFirst Submitted
Initial submission to the registry
November 20, 2019
CompletedFirst Posted
Study publicly available on registry
November 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedAugust 27, 2020
August 1, 2020
12 months
November 20, 2019
August 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Quality of life score
8 weeks
ANS (autonomic nervous system) dysfunction
8 weeks
Other Outcomes (1)
Subjective response to treatment
8 weeks
Study Arms (1)
Manual Therapy
EXPERIMENTAL8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Interventions
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinicas Universitarias UCV
Valencia, 46001, Spain
Related Publications (1)
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.
PMID: 30205597BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria Garcia-Escudero, PhD
Catholic University of Valencia
- STUDY CHAIR
Elisa Oltra, PhD
Catholic University of Valencia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Outcome measures will be randomized and anonymized
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 20, 2019
First Posted
November 22, 2019
Study Start
March 20, 2019
Primary Completion
March 10, 2020
Study Completion
March 10, 2020
Last Updated
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to make IPD available.