- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05442476
Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction
July 1, 2022 updated by: Ziauddin University
Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction Among Postpartum Females- A Randomized Controlled Trial
Pregnancy is the main occasion of every woman's life in which numerous episodes of physiological and anatomical adjustments takes place within woman's body to become a mother.
Anatomical changes often leads to poor biomechanics and may cause mechanical dysfunction of spine especially lower back.. Sacroiliac joint (SIJ) goes through most of mobility during the period of pregnancy due to hormone release causes ligamentous laxity that can cause SIJD.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Fifty two patients will be randomly divided into two groups i.e.
Group-A (n=26) and B (n=26) respectively through simple random sampling, sealed envelope method.
Informed consent will be taken from the participant prior to intervention.
Baseline assessment will be carried out before the first session of all the recruited participants on four outcome measures using, Patrick's FABER test for provocation of pain, NPRS for intensity of pain, RMDQ for physical disability and PALM Pelvic Inclinometer for pelvic asymmetry respectively.
Skin reaction test will be conducted before randomization after the baseline assessment for all participants.
A small patch of kinesio tape will be applied to the hip region and the participants will be asked to keep it for 24 hours.
If any of the participants will develop allergic reaction, it will be removed immediately and participants with positive results will be excluded from the study.
After this test, the allergy-free patients will be randomized into 2 groups for treatment.
Participants of Group-A will be applied KT with conventional physiotherapy while Group-B participants will perform MET with conventional physiotherapy.
Whereas, both the groups will be given 12 sessions of their respective protocol, comprising 20 minutes, 3 times/week for the duration of 4 weeks.
After the end of the intervention, subjects will be reassessed after the last session and data will be collected on the same outcome measures for further evaluation
Study Type
Interventional
Enrollment (Anticipated)
52
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 Contact
- Name: Sabrina Principal Investigator, MPhil
- Phone Number: 03013972147
- Email: sabrina10847@zu.edu.pk
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Recruiting
- Ziauddin University
-
Contact:
- Sabrina, MPhil
-
-
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 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postpartum with diagnosed cases of SIJD dysfunction (after 3 months of delivery) with age range between 20 to 35 years
- Postpartum with unilateral/bilateral both SIJD
- Postpartum with anterior innominate
Exclusion criteria:
- History of any fracture at lower limb in recent 6 months
- Pregnant females
- Spinal stenosis, spondylolisthesis
- Malignancy of spine or lower limb
- Radiculopathy
- Conditions like diastasis recti, prolapse pelvic organ
- History of recent infection
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: kinesiotaping
|
For the KT application, participants will be asked to stand with keeping their feet at shoulder level in a comfortable manner.
The patient will be in a standing position with lumbar spine flexion.
A 5 cm wide long I-shaped piece of tape will be applied with 80% tension transverse to the patient's painful area and the bilateral SIJ region, with no tension applied to the ends of the tape.
Another short piece of tape will be applied with 80% tension at an angle from the painful point to the hip, and no tension will be applied to the ends of the tape.
An identical application will be performed on the other side of the sacroiliac region
conventional physiotherapy
|
|
Other: Muscle Energy Technique
|
conventional physiotherapy
The subject will be asked for the sitting on the treatment table, back towards the therapist.
Then the subject will be taken into flexion, rotation and side bending.
When the subject will reach the tolerated limit of flexion, the therapist will ask him to perform extension, sidebending and rotation to the opposite side while holding the breath for 7-10 seconds and rest for 2-3 seconds, then the patient will be asked to release the breath.
The therapist will wait for the participant's full exhalation and then will take her further in all the directions of restriction, towards the new barrier.
MET will be performed for 10 repetitions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disability
Time Frame: Baseline
|
It will be used for the participants to assess the disability with low back pain, comprised of 24 items regarding functional status that are likely to be affected by LBP.
The scoring of RMQD will show '0' as no disability and '24' as maximum disability
|
Baseline
|
|
Disability
Time Frame: After 4 weeks
|
It will be used for the participants to assess the disability with low back pain, comprised of 24 items regarding functional status that are likely to be affected by LBP.
The scoring of RMQD will show '0' as no disability and '24' as maximum disability
|
After 4 weeks
|
|
Pelvic tilting
Time Frame: Baseline
|
PALM device is portable, convenient to use that combines the features of a caliper and inclinometer.
It is reliable tool used for measuring pelvic tilting angle/inclination by marking a point just inferior to ASIS; another mark inferior to PSIS.
Keeping the calipers of the PALM on these two points to determine the distance in centimeter between two points
|
Baseline
|
|
Pelvic tilting
Time Frame: After 4 weeks
|
PALM device is portable, convenient to use that combines the features of a caliper and inclinometer.
It is reliable tool used for measuring pelvic tilting angle/inclination by marking a point just inferior to ASIS; another mark inferior to PSIS.
Keeping the calipers of the PALM on these two points to determine the distance in centimeter between two points
|
After 4 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)
June 18, 2022
Primary Completion (Anticipated)
September 24, 2022
Study Completion (Anticipated)
October 10, 2022
Study Registration Dates
First Submitted
June 22, 2022
First Submitted That Met QC Criteria
July 1, 2022
First Posted (Actual)
July 5, 2022
Study Record Updates
Last Update Posted (Actual)
July 5, 2022
Last Update Submitted That Met QC Criteria
July 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5490522REH
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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