- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747119
Effect of MET on Meralgia Paraesthesia Postpartum "Muscle Energy Technique" (MET)
The Effect of Muscle Energy Technique on Femoral Meralgia Paraesthesia in Postpartum: A Randomized Controlled Trial
To investigate the effect of muscle energy technique on Femoral meralgia paraesthesia in a postpartum female. BACKGROUND: meralgia paraesthesia is one of the serious disorders in the postpartum female which results in pain and less physical activities.
………HYPOTHESES:
This study hypothesized that:
muscle energy technique will have a significant effect on Femoral meralgia paraesthesia in postpartum female
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Thirty meralgia paraesthesia postpartum females will participate in this study.
The patients will randomly be divided into two equal groups; the control group received the conventional selected exercise program and the study group received the same exercise training program in addition to muscle energy technique, three times per week for four weeks.
The evaluation methods by Femoral nerve conduction velocity will be measured via the Neuropack S1 MEB9004 EMG device before the exercise program and after finishing the exercise program, and also the Pelvic compression test and Pain numeric rating scale
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Select State
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Al Jīzah, Select State, Egypt
- Lama S Mahmoud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Thirty meralgia paraesthesia postpartum female Patients
- with positive Pelvic compression test
- age ranging from 25:40 years
- post vaginal delivery or post-operative (postpartum) persistent dysthesia in anterolateral thigh (one side or both)
- body mass index (20:29.9) Kg/m2
Exclusion Criteria:
- difficulty to communicate or to understand program instructions
- other conditions that caused pain (for example fibromyalgia and arthritis)
- any psychiatric or cognitive symptoms any other musculoskeletal disorders or neurologic diseases of the lower extremities and spine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
received the conventional selected exercise program in addition to muscle energy technique
|
the patient was supine and the therapist fix the lower limb of the affected side then ask the patient to perform isometric contraction for abductors maintained for 3-5 seconds, then the patient was instructed to stop, exhale and relax then the therapist perform further adducted the patient's knee of the affected side as a stretching exercise for Three to five repetitions of these directions were performed.
|
|
Experimental: control group
received the conventional selected exercise program
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Femoral nerve conduction latency
Time Frame: 4 weeks
|
Femoral nerve conduction latency measured via the Neuropack S1 MEB9004 EMG device
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pelvic compression test
Time Frame: four weeks
|
the therapist applied a downward compression force to the pelvis and maintained a pressure for 45 seconds.
If the patients reported an alleviation of symptoms the test is considered positive
|
four weeks
|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: four weeks
|
it includes 11-point numeric scale ranges from no pain with score of "0" to worst pain imaginable with score of "10"
|
four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lama Saad Mahmoud, PHD, October 6 University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T. REC/012/002864
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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