NCT05863390

Brief Summary

To determine the effectiveness of McKenzie exercises and trochanteric belt with conventional physical therapy to reduce pain and dysfunction of Sacroiliac joint (SIJ) in pregnant women

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

March 18, 2023

Last Update Submit

May 16, 2023

Conditions

Sacroiliac Joint Dysfunction

Outcome Measures

Primary Outcomes (1)

  • feature of Visual analogue scale to check pain and feature PSFS to check Movement of joints

    Pre and Post interventions using VAS, PDFS

    6 Months

Study Arms (2)

McKenzie exercise

EXPERIMENTAL
Behavioral: McKenzie exercise

Trochanteric belt

OTHER
Diagnostic Test: Trochanteric belt

Interventions

McKenzie exerciseBEHAVIORAL

routine simple McKenzie exercise

McKenzie exercise
Trochanteric beltDIAGNOSTIC_TEST

Trochanteric belt with conventional physical therapy

Trochanteric belt

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant patients with sacroiliac joint pain are included and participant patients with age group 18- to 35
  • low back pain due to sacroiliac joint who suffer from sever pain during sitting and during positioning change when stand from sitting position are included

You may not qualify if:

  • Patients with age group of below 18 years and above 35 years
  • Patients with disease of coagulopathy
  • systemic infection
  • skin infection over sacroiliac joint patients with history of allergies to injected medications.
  • Patients with psoriasis
  • inflammatory bowel disease
  • peripheral arthritis
  • Women with UTI complications are excluded.
  • Women with respiratory issues are also excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

• General Hospital. • Chaudhary Muhammad Akram Teaching and Research Hospital, University of Lahore Teaching Hospital, Shadman Medical Center, Services Hospital, Bahria International Hospital

Lahore, Pakistan

RECRUITING

Study Officials

  • Abdul Wahab

    Superior Uni

    STUDY CHAIR

Central Study Contacts

Nargiza Saleem, DPT

CONTACT

+923484080406dptm-s19-045@superior.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DEAN

Study Record Dates

First Submitted

March 18, 2023

First Posted

May 18, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

August 31, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)