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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05807009
Other study ID # core exercise for fibromyalgia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 28, 2022
Est. completion date March 28, 2023

Study information

Verified date March 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date March 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 21 Years to 43 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Egypt Engy Ashraf Gamal Mohamed Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary pressure pain thresholds pressure algometer will be used for assessment of pressure pain threshold up to 8 weeks
Secondary pain intensity visual analogue scale will be used for assessment of pain intensity up to 8 weeks
Secondary health status Fibromyalgia Impact Questionnaire (FIQ) will be used for assessment of health status up to 8 weeks
Secondary function state The six-minute walk test (6 MWT) will be used for assessment of function state up to 8 weeks
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