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Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)

Primary Purpose

Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS)

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
Fundación Universidad Católica de Valencia San Vicente Mártir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia (FM) focused on measuring Manual Therapy, Physiotherapy, Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS), RNAseq, microRNA, mechanomiR

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinicas Universitarias UCV

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manual Therapy

Arm Description

8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Outcomes

Primary Outcome Measures

Fatigue score
MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue
Pain index
FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, ≥59 severe
Differential gene expression
RNAseq

Secondary Outcome Measures

Quality of life score
SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health
ANS (autonomic nervous system) dysfunction
Plantar pressure maps

Full Information

First Posted
November 20, 2019
Last Updated
August 25, 2020
Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir
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1. Study Identification

Unique Protocol Identification Number
NCT04174300
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS)
Keywords
Manual Therapy, Physiotherapy, Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS), RNAseq, microRNA, mechanomiR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Outcome measures will be randomized and anonymized
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Experimental
Arm Description
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy
Other Intervention Name(s)
Physiotherapy treatment
Intervention Description
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
Primary Outcome Measure Information:
Title
Fatigue score
Description
MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue
Time Frame
8 weeks
Title
Pain index
Description
FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, ≥59 severe
Time Frame
8 weeks
Title
Differential gene expression
Description
RNAseq
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Quality of life score
Description
SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health
Time Frame
8 weeks
Title
ANS (autonomic nervous system) dysfunction
Description
Plantar pressure maps
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Subjective response to treatment
Description
Custom-made questionnaire, -1 to +1 scale (ítems 1-5), scale 1-10 (item 6), 6 items total, higher scores indicate improvement of symptoms
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Garcia-Escudero, PhD
Organizational Affiliation
Catholic University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisa Oltra, PhD
Organizational Affiliation
Catholic University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
Clinicas Universitarias UCV
City
Valencia
ZIP/Postal Code
46001
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Citations:
PubMed Identifier
30205597
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.
Results Reference
background
Links:
URL
https://www.ucv.es/investigacion/grupos-de-investigacion/grupoclave/1431
Description
UCV Physiotherapy Research Group

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Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)

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