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Completed

NCT Number: NCT05807009

Role of Core Exercise in Treatment of 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

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

21 year–43 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Engy Ashraf Gamal Mohamed

Giza, 11251, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • surgical history for previous 6 months.

Treatment and study plan

Core Exercise

Other

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

Other

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

Primary outcomes

  1. pressure pain thresholds

    Time frame: up to 8 weeks

    pressure algometer will be used for assessment of pressure pain threshold

Secondary outcomes

  1. pain intensity

    Time frame: up to 8 weeks

    visual analogue scale will be used for assessment of pain intensity

  2. health status

    Time frame: up to 8 weeks

    Fibromyalgia Impact Questionnaire (FIQ) will be used for assessment of health status

  3. function state

    Time frame: up to 8 weeks

    The six-minute walk test (6 MWT) will be used for assessment of function state

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 10, 2023
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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