Effectiveness of McKenzie and Trochanteric Belt With CT T... | NCT05863390

Studies
Effectiveness of McKenzie and Trochanteric Belt With CT Therapy to Reduce Pain and Dysfunction of SI Joint

NCT05863390

Sponsor

Superior University

Status

Unknown status

Last Update Posted

May 18, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Sacroiliac Joint Dysfunction

Interventions

McKenzie exercise
Trochanteric belt

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Mar 18, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2023

Last Update Posted Date

May 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

to findout the effectiveness of exercises in pregnant women

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
McKenzie exercise	Experimental		Behavioral: McKenzie exercise
Trochanteric belt	Other		Diagnostic Test: Trochanteric belt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
McKenzie exercise	Behavioral	routine simple McKenzie exercise	McKenzie exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nargiza Saleem, DPT	Contact	+923484080406		dptm-s19-045@superior.edu.pk

Overall Officials

Name	Affiliation	Role
Abdul Wahab	Superior Uni	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
• General Hospital. • Chaudhary Muhammad Akram Teaching and Research Hospital, University of Lahore Teaching Hospital, Shadman Medical Center, Services Hospital, Bahria International Hospital	Recruiting	Lahore			Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided