Effects of Therapeutic Exercise in Patients With Fibromyalgia

Not Applicable

Completed

• Conditions: Chronic Pain; Therapeutic Exercise
• Interventions: Other: Therapeutic Exercise

• Registration Number: NCT04817605
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

The objective of this trial is to evaluate if therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.

For this purpose, the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Patients included one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-10
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-26
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Diagnosed medically with Fibromyalgia
• Diagnosed according to the American College of Rheumatology criteria
• Agreement to attend to treatment sessions

Exclusion Criteria

• Any kind of contraindications for physical activity
• Other kind of diseases that could limit the intervention
• Previous surgery last year
• Medication modifications in the last 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise Therapy	Therapeutic Exercise	-

Primary Outcome Measures

Name	Time	Method
Quality of Sleep	through study completion, an average 10 weeks	The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Pain intensity	through study completion, an average 10 weeks	VAS

Secondary Outcome Measures

Name	Time	Method
Analysis of tryptophan metabolites	through study completion, an average 10 weeks	The investigators measure the tryptophan metabolites with blood test analysis at baseline
Pressure pain threshold	through study completion, an average 10 weeks	The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment
Central sensitization	through study completion, an average 10 weeks	The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS)

Trial Locations

Locations (1)

Sandra Jiménez Jiménez-del-Barrio; 🇪🇸 Soria, Spain