- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05785104
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
March 5, 2024 updated by: Samar Ahmed Abd EL Salam Negm, Cairo University
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain in Premenopausal Women With Fibromyalgia
The aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points.
It is multisystem disease characterized by sleep disturbance and fatigue.
It affect 5% of the world population.
The incidence is higher in women than in men.
And the age is between 30 and 35 years old.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Premenopausal women with fibromyalgia
- Ages ranges between 30 - 45 years old
- Body mass index < 35 kg/m2
- All are medically stable
Exclusion Criteria:
- specific cervical and lumbar pain
- Smokers
- Pregnant women
- Medically unstable
- Postmenopausal women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Myofascial release
The patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks
|
Is Facilitation of mechanical and neurological adaptive capacity as integrated through the Myofascial system
|
|
Experimental: Muscle energy technique
The patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks
|
Is manual therapy procedure that involves alternating periods of resisted muscle contraction and assisted stretching
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Active range of motion of cervical and lumbar regions
Time Frame: Four weeks
|
Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment
|
Four weeks
|
|
Fibromyalgia impact questionnaire
Time Frame: Four weeks
|
Used to assess health related quality of life before and after the treatment, maximum score means worse outcome
|
Four weeks
|
|
Visual analogue scale
Time Frame: Four weeks
|
Used to assess the severity of cervical and lumbar pain of each premenopausal women in both groups before and after the treatment, maximum score means worse outcome
|
Four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
March 14, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/004046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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