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Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction

Primary Purpose

Musculoskeletal Injury

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kinesiotaping
Muscle Energy Technique
conventional physiotherapy
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Injury focused on measuring Sacroiliac joint, Exercise, Muscle energy technique

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ziauddin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

kinesiotaping

Muscle Energy Technique

Arm Description

Outcomes

Primary Outcome Measures

Disability
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
Disability
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
Pelvic tilting
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
Pelvic tilting
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

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
July 1, 2022
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05442476
Brief Title
Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction
Official Title
Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction Among Postpartum Females- A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2022 (Actual)
Primary Completion Date
September 24, 2022 (Anticipated)
Study Completion Date
October 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Injury
Keywords
Sacroiliac joint, Exercise, Muscle energy technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kinesiotaping
Arm Type
Experimental
Arm Title
Muscle Energy Technique
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Kinesiotaping
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Muscle Energy Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
conventional physiotherapy
Primary Outcome Measure Information:
Title
Disability
Description
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
Time Frame
Baseline
Title
Disability
Description
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
Time Frame
After 4 weeks
Title
Pelvic tilting
Description
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
Time Frame
Baseline
Title
Pelvic tilting
Description
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
Time Frame
After 4 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Principal Investigator, MPhil
Phone
03013972147
Email
sabrina10847@zu.edu.pk
Facility Information:
Facility Name
Ziauddin University
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina, MPhil

12. IPD Sharing Statement

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Effects of Kinesio-Taping and Muscle Energy Technique on Chronic Sacroiliac Joint Dysfunction

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