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Role of Core Exercise in Treatment of Fibromyalgia Patients

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
core exercise
traditional therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia syndrome, core exercise, aerobic exercise, pressure pain threshold

Eligibility Criteria

21 Years - 43 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Engy Ashraf Gamal Mohamed

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

core exercise

Arm Description

the patients will receive seven core exercises two times a week for eight weeks

Outcomes

Primary Outcome Measures

pressure pain thresholds
pressure algometer will be used for assessment of pressure pain threshold

Secondary Outcome Measures

pain intensity
visual analogue scale will be used for assessment of pain intensity
health status
Fibromyalgia Impact Questionnaire (FIQ) will be used for assessment of health status
function state
The six-minute walk test (6 MWT) will be used for assessment of function state

Full Information

First Posted
March 28, 2023
Last Updated
March 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05807009
Brief Title
Role of Core Exercise in Treatment of Fibromyalgia Patients
Official Title
Effect of Core Exercise on Health Status, Pain in Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia syndrome, core exercise, aerobic exercise, pressure pain threshold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
core exerscie
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
core exercise
Arm Type
Experimental
Arm Description
the patients will receive seven core exercises two times a week for eight weeks
Intervention Type
Other
Intervention Name(s)
core exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional therapy
Other Intervention Name(s)
aerobic exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
pressure pain thresholds
Description
pressure algometer will be used for assessment of pressure pain threshold
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
pain intensity
Description
visual analogue scale will be used for assessment of pain intensity
Time Frame
up to 8 weeks
Title
health status
Description
Fibromyalgia Impact Questionnaire (FIQ) will be used for assessment of health status
Time Frame
up to 8 weeks
Title
function state
Description
The six-minute walk test (6 MWT) will be used for assessment of function state
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Engy Ashraf Gamal Mohamed
City
Giza
ZIP/Postal Code
11251
Country
Egypt

12. IPD Sharing Statement

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Role of Core Exercise in Treatment of Fibromyalgia Patients

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