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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05442476
Other study ID # 5490522REH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 18, 2022
Est. completion date October 10, 2022

Study information

Verified date June 2022
Source Ziauddin University
Contact Sabrina Principal Investigator, MPhil
Phone 03013972147
Email sabrina10847@zu.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date October 10, 2022
Est. primary completion date September 24, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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
Muscle Energy Technique
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.
conventional physiotherapy
conventional physiotherapy

Locations

Country Name City State
Pakistan Ziauddin University Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline
Primary 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 After 4 weeks
Primary 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 Baseline
Primary 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 After 4 weeks
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