Modified Sims Versus Lumbar Roll Manipulation in Patients... | NCT07258537

Studies
Modified Sims Versus Lumbar Roll Manipulation in Patients With Sacroiliac Joint Dysfunction

NCT07258537

Sponsor

University of Lahore

Status

Enrolling by invitation

Last Update Posted

Dec 2, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sacroiliac Joint Dysfunction

Interventions

modified SIM manipulation

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2024Actual

Primary Completion Date

Dec 22, 2025Estimated

Completion Date

Dec 22, 2025Estimated

First Submitted Date

Jul 22, 2025

First Submission Date that Met QC Criteria

Nov 28, 2025

First Posted Date

Dec 2, 2025Actual

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

Nov 28, 2025

Last Update Posted Date

Dec 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This randomized controlled trial aims to compare the efficacy of two manual therapy techniques. Modified Sims Manipulation and Lumbar Roll Manipulation in treating Sacroiliac Joint Dysfunction (SIJD). The study will examine their effects on pain, quality of life, and well-being.

Detailed Description

The study investigates the short- and long-term therapeutic benefits of two different high-velocity low-amplitude thrust techniques, specifically Modified Sims and Lumbar Roll Manipulation, administered along with conventional therapy. Outcomes will be measured using NPRS, SF-36, WHO-5, and gait analysis (MaxTRAQ). Patients will be randomly assigned and blinded to the treatment group. Data collection will be conducted at Rasool Medical Complex, Gujrat.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	modified SIM	Other: modified SIM manipulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified SIM manipulation	Other	manipulation	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
numeric pain rating scale	Numeric pain rating scale: ranging from 0 ("no pain") to 10 ("worst possible pain")	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 19-50

Either gender

Chronic LBP >1 month

3 or more positive SIJ provocation/motion tests

NPRS ≥3 at baseline

Exclusion Criteria:

Pelvic fracture

MRI-confirmed nerve root compression

Psoriatic/Reactive Arthritis

Elevated ESR/CRP

Neurological signs

Severe pain (NPRS >8)

Other red flags (malignancy, fever, etc.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof. Dr. Ashfaq Ahmed, PHD PT	University of Lahore	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rasool Medical Complex		Gujrat	Punjab Province	52000	Pakistan