Role of Core Exercise in Treatment of Fibromyalgia Patients

Effect of Core Exercise on Health Status, Pain in Fibromyalgia Patients

the purpose of this study is to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: core exercise; Other: traditional therapy

Detailed Description

Fibromyalgia (FM) is a chronic non-degenerative disease of unknown etiology without effective medical treatment that mostly affects women. At present, the diagnostic and classification criteria are still under debate. As a result, the treatments for FM are also under investigation. No single treatment has achieved a reduction in the symptoms. Its occurrence increases with age. Exercise is one of the treatment approaches where effectiveness in the management of FM is supported by stronger evidence. Besides, recent reviews found that exercise has a positive effect on pain, physical function and health-related quality of life .with no associated adverse effects. Among the different exercise modalities available, core stability training has shown its effectiveness by improving static and dynamic balance, functionality and risk of falls, pain and quality of life. so This study will be conducted to investigate the effect of core exercises on health status, pain, pressure pain thresholds and functional capacity in patients with FM

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11251
    • Engy Ashraf Gamal Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Patient referred from rheumatologist with a history of widespread bilateral musculoskeletal pain both above and below the waist for a minimum of three months and pain in at least 11 of 18 specific tender points 2. moderate or greater tenderness reported on digital palpation with 4 kg/cm2 of force 3. 21_43 years old patients

Exclusion Criteria:

- 1. presence of other systemic, somatic, or psychiatric diseases. 2. pregnant or were planning a pregnancy during the study period. 3. patients with acute disease including high fever and uncontrolled medical conditions (such as severe infection and cardiovascular disease including unstable angina.

4. surgical history for previous 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: core exercise; the patients will receive seven core exercises two times a week for eight weeks

Other: core exercise; the patients will receive seven exercises performed in crook lying and side lying position on exercise mats. Cushions were used to allow the participants to be comfortable in all positions. The exercises in the crook lying position were core activation with breathing, single-leg lift with knees bent, single-leg slides, bridging and knee drop sideways. The exercises completed in side lying included hip external rotation with knees bent and hip abduction with knees straight.; Other: traditional therapy; the patients will receive : an active warm-up including low intensity movements and dynamic stretching; choreographed aerobic training, progressing gradually from low to moderate intensity; and a cool-down involving low intensity movements, and dynamic and static stretching; Other Names: aerobic exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressure pain thresholds	pressure algometer will be used for assessment of pressure pain threshold	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	visual analogue scale will be used for assessment of pain intensity	up to 8 weeks
health status	Fibromyalgia Impact Questionnaire (FIQ) will be used for assessment of health status	up to 8 weeks
function state	The six-minute walk test (6 MWT) will be used for assessment of function state	up to 8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: aerobic exercise; fibromyalgia syndrome; pressure pain threshold; core exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: core exercise for fibromyalgia

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No