Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
Primary Purpose
Lumbar Pain Syndrome, Cervical Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Myofascial release
Muscle energy technique
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Pain Syndrome focused on measuring Cervical pain,lumbar pain,fibromyalgia
Eligibility Criteria
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
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Myofascial release
Muscle energy technique
Arm Description
The patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks
The patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks
Outcomes
Primary Outcome Measures
Fibromyalgia impact questionnaire
Used to assess health related quality of life before and after the treatment, maximum score means worse outcome
Visual analogue scale
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
Active range of motion of cervical and lumbar regions
Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05785104
Brief Title
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
Official Title
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain in Premenopausal Women With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Pain Syndrome, Cervical Pain
Keywords
Cervical pain,lumbar pain,fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups, one group will be treated by muscle energy technique and other will be treated by myofascial release
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double masking
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myofascial release
Arm Type
Experimental
Arm Description
The patients will receive myofascial release technique on cervical and lumbar regions three times per week for four weeks
Arm Title
Muscle energy technique
Arm Type
Experimental
Arm Description
The patients will receive muscle energy technique for cervical and lumbar regions three times per week for four weeks
Intervention Type
Other
Intervention Name(s)
Myofascial release
Intervention Description
Is Facilitation of mechanical and neurological adaptive capacity as integrated through the Myofascial system
Intervention Type
Other
Intervention Name(s)
Muscle energy technique
Intervention Description
Is manual therapy procedure that involves alternating periods of resisted muscle contraction and assisted stretching
Primary Outcome Measure Information:
Title
Fibromyalgia impact questionnaire
Description
Used to assess health related quality of life before and after the treatment, maximum score means worse outcome
Time Frame
Four weeks
Title
Visual analogue scale
Description
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
Time Frame
Four weeks
Title
Active range of motion of cervical and lumbar regions
Description
Measurement of active flexion, extension, lateral flexion in cervical and lumbar regions before and after the treatment
Time Frame
Four weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samar A Negm, Master
Phone
01061712522
Email
Samarahmednegm@gmail.com
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samar A Ahmed, Master
Phone
01061712622
Email
Samarahmednegm@gmail.com
First Name & Middle Initial & Last Name & Degree
Samar A Negm
Phone
01061712522
Email
Samarahmednegm@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Muscle Energy Technique Versus Myofascial Release on Cervical and Lumbar Pain
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