Effects of Therapeutic Exercise in Patients With Fibromyalgia

Chronic Pain Clinical Trial

Official title:

Effects of Therapeutic Exercise in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817605
• Other study ID #: UVa
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: May 2023
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 20, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Therapeutic Exercise

Intervention

Other:
• Therapeutic Exercise
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Locations

Country	Name	City	State
Spain	Sandra Jiménez Jiménez-del-Barrio	Soria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	VAS	Baseline
Primary	Pain intensity	VAS	through study completion, an average 10 weeks
Primary	Quality of Sleep	The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline	Baseline
Primary	Quality of Sleep	The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline	through study completion, an average 10 weeks
Secondary	Pressure pain threshold	The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline	Baseline
Secondary	Pressure pain threshold	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	through study completion, an average 10 weeks
Secondary	Central sensitization	The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline	Baseline
Secondary	Central sensitization	The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS)	through study completion, an average 10 weeks
Secondary	Analysis of tryptophan metabolites	The investigators measure the tryptophan metabolites with blood test analysis at baseline	Baseline
Secondary	Analysis of tryptophan metabolites	The investigators measure the tryptophan metabolites with blood test analysis at baseline	through study completion, an average 10 weeks