Fibromyalgia (FM)NCT04174300

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

A study testing Manual Therapy in people with Fibromyalgia (FM) and Chronic Fatigue Syndrome (CFS), run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS)
What is being tested?: Manual Therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSpain
Study dates: 20 Mar 2019to 10 Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Any uncompliance with what is described as inclusion criteria

Trial locations and contacts

1 site in 1 country.

Spain1 site

Clinicas Universitarias UCV
Valencia, 46001

Other trials in Spain

About this study

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.

Read the 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.

Conditions: Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS)
Being tested: Manual Therapy
Keywords: Manual Therapy, Physiotherapy, Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS), RNAseq, microRNA, mechanomiR
Medical subject headings: Fibromyalgia, Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual TherapyProcedure or surgery
Also called Physiotherapy treatment
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Study groups in NCT04174300
Study group	Role	What they receive
Manual Therapy	Experimental	8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N Receives: Procedure: Manual Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Fatigue score
MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue
Measured: 8 weeks
Pain index
FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, ≥59 severe
Measured: 8 weeks
Differential gene expression
RNAseq
Measured: 8 weeks

Secondary outcomes (2)

Quality of life score
SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health
Measured: 8 weeks
ANS (autonomic nervous system) dysfunction
Plantar pressure maps
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201910 Mar 2020

First posted22 Nov 2019
Study start20 Mar 2019
Primary completion10 Mar 2020
Study completion10 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04174300
Sponsor's protocol ID: UCV/2018-2019/076
Status last verified: Aug 2020
First submitted: 20 Nov 2019
Last updated: 27 Aug 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is not a plan to make IPD available.

Publications

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.
PubMed 30205597

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Recruiting
Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia
Fibromyalgia (FM)
Not yet recruiting
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
Fibromyalgia, Fibromyalgia (FM)
Not yet recruiting
Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities
Fibromyalgia, Fibromyalgia (FM)

All Fibromyalgia (FM) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Molecular Response to Custom Manual Physiotherapy Treatment of Fibromyalgia & Chronic Fatigue Syndrome (CFS)
ClinicalTrials.gov ID: NCT04174300
Acronym / sponsor ID: UCV/2018-2019/076
Conditions: Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS)
Keywords: Manual Therapy, Physiotherapy, Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS), RNAseq, microRNA, mechanomiR
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
Study start: 20 Mar 2019 (actual)
Primary completion: 10 Mar 2020 (actual)
Study completion: 10 Mar 2020 (actual)
First posted: 22 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Manual Therapy	Experimental	Procedure: Manual Therapy8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (1 listed)

Any uncompliance with what is described as inclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Manual TherapyAlso: Physiotherapy treatment8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N	Procedure or surgery	Manual Therapy

Primary outcome

Fatigue score
Time frame: 8 weeks
MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue
Pain index
Time frame: 8 weeks
FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, ≥59 severe
Differential gene expression
Time frame: 8 weeks
RNAseq

2 secondary outcomes

Quality of life score
Time frame: 8 weeks
ANS (autonomic nervous system) dysfunction
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
Background: PubMed 30205597Espejo 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.
UCV Physiotherapy Research GroupLink provided by the sponsor.
Individual participant dataSharing planned: No. There is not a plan to make IPD available.

Related trials for Fibromyalgia (FM)

Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Recruiting
Feasibility and Effects of Noninvasive Brain Stimulation on Pain Perception in People With Fibromyalgia
Fibromyalgia (FM)
Not yet recruiting
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
Fibromyalgia, Fibromyalgia (FM)
Not yet recruiting
Multisite Transcutaneous Electrical Nerve Stimulation in Fibromyalgia: A Randomized, Double-Blind, Sham-Controlled Crossover Trial Comparing Two Stimulation Modalities
Fibromyalgia, Fibromyalgia (FM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria Garcia-Escudero, PhD principal investigator

Catholic University of Valencia

Elisa Oltra, PhD study chair

Catholic University of Valencia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy in people with Fibromyalgia (FM) and Chronic Fatigue Syndrome (CFS), run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fatigue score (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04174300, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.