- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04790500
Effects Of Muscle Energy Technique Versus Mobilization
September 17, 2021 updated by: Riphah International University
Effects Of Muscle Energy Technique Versus Mobilization On Pain And Disability In Post-Partum Females With Sacroiliac Joint Dysfunction.
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim is to describe the severity of pain in postpartum female and management of sacroiliac joint pain and disability and define the effects of manual therapy on sacroiliac joint dysfunction and pain in postpartum females and to check whether the amount of gaining range of movement is similar among postpartum female undergoing with mobilization therapy and with muscle energy technique.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Pakistan Railway Hospital
-
-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20-40 year having unilateral back pain around or on sacral sulcus,
- Positive posterior pain provocation test for Sacroiliac joint dysfunction,
- Low back pain within six weeks of delivery
- Pain while sitting down, lying on the ipsilateral side of pain, or climbing stairs.
- Local tenderness of the posterior aspect of the sacroiliac joint
- Pain is usually localized over the buttock.
- Sharp, stabbing, and/or shooting pain which extends down the posterior thigh usually not past the knee.
- C-section
Exclusion Criteria:
- Neurological deficit
- Spinal tumors
- Scoliosis,
- Underwent spinal surgery and prolapsed
- Intervertebral disc with or without radiculopathy
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A
mobilization technique
|
Mobilization of sacroiliac joint which will increase the range of motion and reduction in pain and improvement in functional limitation.
|
|
Experimental: Group B
muscle energy technique
|
Muscle energy technique it is known as active muscular relaxation technique.
It helps in lengthening the shorten muscle and increasing range of restricted muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric pain rating scale
Time Frame: 4th week
|
o The 11-point (numeric pain rating scale) NPRS will use to capture the patient's level of pain.
The scale is anchored on the left with the phrase ''no pain'' and on the right with the phrase ''worst imaginable pain.''
Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours.
The average of the 3 ratings or any single rating may be used to represent the patient's level of pain.
Numeric pain scales have been shown to be reliable and valid.
The reliability of numeric pain rating scale is 0.74
|
4th week
|
|
Modified Oswestry disability index
Time Frame: 4th week
|
It is a self-report questionnaire of a patient's perceived disability based on 10 areas of pain and daily activities (pain intensity, personal hygiene, lifting, walking, sitting, standing, sleeping, sexual activity, social activity and travelling).
Each section is scored on a6-point scale (0-5), with 0 representing no limitation and 5 representing maximal limitation.
The subscales combined add up to a total maximal score of 50.
The score is then doubled and interpreted as a percentage of the patient-perceived disability (the higher the score, the greater the disability).
In cases where patients did not answer all the 10 sections, the sum score of the answered sections were divided by the number of completed sections.
The reliability of modified oswestry disability index is 0.88.
|
4th week
|
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)
October 14, 2020
Primary Completion (Actual)
August 20, 2021
Study Completion (Actual)
August 20, 2021
Study Registration Dates
First Submitted
March 7, 2021
First Submitted That Met QC Criteria
March 7, 2021
First Posted (Actual)
March 10, 2021
Study Record Updates
Last Update Posted (Actual)
September 23, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00846 Nusrat Javed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.