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

Chronic Fatigue Syndrome (CFS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04174300
• Other study ID #: UCV/2018-2019/076
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: August 2020
• Source: Fundación Universidad Católica de Valencia San Vicente Mártir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome (CFS)
• Fatigue
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Fibromyalgia (FM)
• Myofascial Pain Syndromes
• Syndrome

Intervention

Procedure:
• Manual Therapy
8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N

Locations

Country	Name	City	State
Spain	Clinicas Universitarias UCV	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universidad Católica de Valencia San Vicente Mártir

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Espejo JA, García-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). pii: E2673. doi: 10.3390/ijms19092673. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective response to treatment	Custom-made questionnaire, -1 to +1 scale (ítems 1-5), scale 1-10 (item 6), 6 items total, higher scores indicate improvement of symptoms	8 weeks
Primary	Fatigue score	MFI, 1-5 scale (20 items), higher scores indicate higher degree of fatigue	8 weeks
Primary	Pain index	FIQ and Visual analogue scale (VAS) of pain, Scale 0-100, <39 mild, 39-58 moderate, =59 severe	8 weeks
Primary	Differential gene expression	RNAseq	8 weeks
Secondary	Quality of life score	SF-36, 0-100 Likert scale (36 items), lower scores indicate poorer quality of health	8 weeks
Secondary	ANS (autonomic nervous system) dysfunction	Plantar pressure maps	8 weeks

External Links

•   UCV Physiotherapy Research Group