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

• Sponsor: Foundation University Islamabad (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05691907
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site: 20
• Patients Per Site Per Month: 0.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain, Mechanical	Device: THE therapy; Procedure: Directional Preference Exercises; Procedure: Motor Control Exercises	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects Of Directional Preference Exercises in Comparison to Motor Control Exercises in Patients With Mechanical Low Back Pain
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Directional Preference Exercises Directional Preference Exercises will be provided, also known as Mckenzie's extension exercises	Device: THE therapy; THE therapy consisting of: Heating Pad Interferential Therapy; Procedure: Directional Preference Exercises; Directional Preference Exercises consisting of Mckenzie's extension protocol
Experimental: Motor Control Exercises Motor Control Exercises consisting of extension bias external limb loading protocol.	Device: THE therapy; THE therapy consisting of: Heating Pad Interferential Therapy; Procedure: Motor Control Exercises; Motor Control Exercises consisting of External limb loading extension protocol

Outcome Measures

Primary Outcome Measures

1. Back Pain [2 week]

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

2. Disability [2 week]

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

3. Range of Motion [2 week]

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

4. Sleep Quality [2 week]

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

5. Postural Stability Index [2 week]

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

6. Real time Physical Activity [2 week]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foundation University	Islamabad		Pakistan
2	Kulsum International Hospital	Islamabad		Pakistan

Sponsors and Collaborators

• Foundation University Islamabad

Investigators

• Principal Investigator: Muhammad Osama, PhD*, FUI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Foundation University Islamabad
• ClinicalTrials.gov Identifier: NCT05691907
• Other Study ID Numbers: FUI/CTR/2023/2
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 20, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Jan 20, 2023