NCT05691907

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

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 Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

1.8 years

First QC Date

January 11, 2023

Last Update Submit

January 11, 2023

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (6)

  • Back Pain

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

    2 week

  • Disability

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

    2 week

  • Range of Motion

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

    2 week

  • Sleep Quality

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

    2 week

  • Postural Stability Index

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

    2 week

  • Real time Physical Activity

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

    2 week

Study Arms (2)

Directional Preference Exercises

EXPERIMENTAL

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

Device: THE therapyProcedure: Directional Preference Exercises

Motor Control Exercises

EXPERIMENTAL

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

Device: THE therapyProcedure: Motor Control Exercises

Interventions

THE therapyDEVICE

THE therapy consisting of: * Heating Pad * Interferential Therapy

Directional Preference ExercisesMotor Control Exercises
Directional Preference ExercisesPROCEDURE

Directional Preference Exercises consisting of Mckenzie's extension protocol

Directional Preference Exercises
Motor Control ExercisesPROCEDURE

Motor Control Exercises consisting of External limb loading extension protocol

Motor Control Exercises

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Both male \& Female patients
  • Age group 20-60 Years
  • Diagnosed with mechanical low back pain having pain aggravation in flexion bias

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foundation University

Islamabad, Pakistan

Location

Kulsum International Hospital

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammad Osama, PhD*

    FUI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

February 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)