NCT05442476

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

June 22, 2022

Last Update Submit

July 1, 2022

Conditions

Keywords

Sacroiliac jointExerciseMuscle energy technique

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

kinesiotaping

EXPERIMENTAL
Other: KinesiotapingOther: conventional physiotherapy

Muscle Energy Technique

OTHER
Other: Muscle Energy TechniqueOther: conventional physiotherapy

Interventions

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

kinesiotaping

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.

Muscle Energy Technique

conventional physiotherapy

Muscle Energy Techniquekinesiotaping

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziauddin University

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Sabrina Principal Investigator, MPhil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 5, 2022

Study Start

June 18, 2022

Primary Completion

September 24, 2022

Study Completion

October 10, 2022

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations