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Directional Preference Exercises in Comparison to Motor Control Exercises in Mechanical Low Back Pain

Primary Purpose

Low Back Pain, Mechanical

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

THE therapy

Directional Preference Exercises

Motor Control Exercises

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both male & Female patients Age group 20-60 Years Diagnosed with mechanical low back pain having pain aggravation in flexion bias Exclusion Criteria: Lumbar stenosis Cauda Equina Spondylolisthesis Ankylosing Spondylitis Scoliosis Leg Length Discrepancy Muscular Dystrophy Low back pain from non-musculoskeletal causes Fracture or traumatic low back pain Any infection, tumor, spinal surgery, cognitive impairments, or any other rheumatologic disease would be excluded

Sites / Locations

Foundation University
Kulsum International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Directional Preference Exercises

Motor Control Exercises

Arm Description

Directional Preference Exercises will be provided, also known as Mckenzie's extension exercises

Motor Control Exercises consisting of extension bias external limb loading protocol.

Outcomes

Primary Outcome Measures

Back Pain

Pain will be measured using Numeric Pain Rating Scale, on a scale of 1 to 10. higher scores represent poorer outcome.

Disability

Disability will be measured using Roland Morris Disability Questionnaire. Higher scores represent poorer outcome.

Range of Motion

Range of Motion will be measured using inclinometer. Higher scores represent better outcome.

Sleep Quality

Sleep Quality will be measured using Pittsburg Sleep Quality Index. Higher scores represent poorer outcome.

Postural Stability Index

Postural Stability Index will be measured using Biodex Balance System. Higher scores represent poorer outcome.

Real time Physical Activity

Real time Physical Activity will be measured using wearable sensor technology. Higher scores represent better outcome.

Secondary Outcome Measures

Full Information

NCT ID

NCT05691907

First Posted

January 11, 2023

Last Updated

January 11, 2023

Sponsor

Foundation University Islamabad

1. Study Identification

Unique Protocol Identification Number

NCT05691907

Brief Title

Directional Preference Exercises in Comparison to Motor Control Exercises in Mechanical Low Back Pain

Official Title

Effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Mechanical

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Directional Preference Exercises

Arm Type

Experimental

Arm Description

Directional Preference Exercises will be provided, also known as Mckenzie's extension exercises

Arm Title

Motor Control Exercises

Arm Type

Experimental

Arm Description

Motor Control Exercises consisting of extension bias external limb loading protocol.

Intervention Type

Device

Intervention Name(s)

THE therapy

Intervention Description

THE therapy consisting of: Heating Pad Interferential Therapy

Intervention Type

Procedure

Intervention Name(s)

Directional Preference Exercises

Intervention Description

Directional Preference Exercises consisting of Mckenzie's extension protocol

Intervention Type

Procedure

Intervention Name(s)

Motor Control Exercises

Intervention Description

Motor Control Exercises consisting of External limb loading extension protocol

Primary Outcome Measure Information:

Title

Back Pain

Description

Pain will be measured using Numeric Pain Rating Scale, on a scale of 1 to 10. higher scores represent poorer outcome.

Time Frame

2 week

Title

Disability

Description

Disability will be measured using Roland Morris Disability Questionnaire. Higher scores represent poorer outcome.

Time Frame

2 week

Title

Range of Motion

Description

Range of Motion will be measured using inclinometer. Higher scores represent better outcome.

Time Frame

2 week

Title

Sleep Quality

Description

Sleep Quality will be measured using Pittsburg Sleep Quality Index. Higher scores represent poorer outcome.

Time Frame

2 week

Title

Postural Stability Index

Description

Postural Stability Index will be measured using Biodex Balance System. Higher scores represent poorer outcome.

Time Frame

2 week

Title

Real time Physical Activity

Description

Real time Physical Activity will be measured using wearable sensor technology. Higher scores represent better outcome.

Time Frame

2 week

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Osama, PhD*

Organizational Affiliation

FUI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Foundation University

City

Islamabad

Country

Pakistan

Facility Name

Kulsum International Hospital

City

Islamabad

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Directional Preference Exercises in Comparison to Motor Control Exercises in Mechanical Low Back Pain

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