- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088837
Muscle Energy Technique on Sacroiliac Dysfunction
October 19, 2021 updated by: Ghada Ebrahim El Refaye, Cairo University
Effect of Muscle Energy Technique on Postpartum Sacroiliac Joint Dysfunction
Sacroiliac pain is a huge problem in women during pregnancy and postpartum period.
Muscle energy technique has potential effect in decreasing the pain and disability
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A sample of forty women diagnosed with postpartum sacroiliac dysfunction, their ages ranged from 20 to 40 years and their BMI was ranged from 25-30 kg / m2 participated in this study, they were selected and divided randomly into 2 equal groups (A&B).
Group (A) (Control group): consisted of 20 patients, they received muscle energy technique for 12 sessions, 3 sessions / week.
Group (B) (Study group): consisted of 20 patients, they received alternative heat and ice for another 20 minutes /session (10 minutes for each).
All patients in both group were evaluated at the beginning of the study and after 12 sessions through measuring pain intensity using visual analog scale and disability using oswestry disability index (ODI)
Study Type
Interventional
Enrollment (Actual)
40
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
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Giza, Egypt, 12613
- Ghada Ebrahim Elrefaye
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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
20 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Their ages ranged from 20 to 40 years .
- Their BMI was ranged from 25-30 kg / m2
Exclusion Criteria:
- hip fracture,
- SIJ infection.
- scoliosis
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: muscle energy technique
muscle energy technique was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles, it was done 3 times per session for 12 sessions.
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MET was performed in the form of post-isometric relaxation technique for iliopsoas, hamstrings, and erector spinae and quadratus lumborum muscles.
the limb was taken very slightly beyond the restriction barrier and was held there for 10-30 seconds, it was done 3 times per session for 12 sessions.
|
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EXPERIMENTAL: ice and heat packs
Alternating ice and heat (20 min , 10 heat,10 cold),3times per week for 12sessions.
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Applying 20 minutes: 10 minutes hot,10 minutes cold on sacroiliac area, 3 times per week for 12 sessions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale Visual anlage scale
Time Frame: 4 weeks
|
It was used for determining pain intensity before and after the treatment course for each patients in both groups (A&B).
Visual analogue scale is a-10 centimeters line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry disability index
Time Frame: 4 weeks
|
The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.
The scores for all questions answered are summed, were used to measure the level of disability before and after treatment
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4 weeks
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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)
February 1, 2020
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
July 30, 2020
Study Registration Dates
First Submitted
October 8, 2021
First Submitted That Met QC Criteria
October 19, 2021
First Posted (ACTUAL)
October 22, 2021
Study Record Updates
Last Update Posted (ACTUAL)
October 22, 2021
Last Update Submitted That Met QC Criteria
October 19, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Cairo Un113
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.