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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

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

NCT ID

NCT04174300

First Posted

November 20, 2019

Last Updated

August 25, 2020

Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

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

Studies a U.S. FDA-regulated Device Product

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

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

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

Learn more about this trial

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

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