Effect of the Hands- on McKenzie Program on Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: McKenzie group; Other: Control group

• Registration Number: NCT03066674
• Lead Sponsor: Imam Abdulrahman Bin Faisal University

Brief Summary

Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP.

The objectives of this study are to determine the effect of the hands-on McKenzie program on pain, disability, spine mobility, and posture deviations in subjects with derangement low back pain.

Detailed Description

Thirty eight patients with sub-acute and chronic LBP will be randomly assigned to the McKenzie group (MG) or the control group (CG). The MG will perform exercises with the hands-on procedure (three sessions per week) for two weeks, while the CG will perform only exercises for two weeks. Both groups will do a home exercise program. The outcome assessments will measure pain by the Pain Numerical Rating Scale (NPRS), the level of disability through the Oswestry Disability Index (ODI), spine mobility by range of motion (ROM) for the lumbar spine, and the centralization of symptoms and the postural alternation by postural analysis grid (PAG). By using SPSS version 20, a paired t-test will be use to study the effect of the McKenzie program before and after treatment. An independent t-test will be used to study the significance between the two groups.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-01-01
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-02-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible.

Exclusion Criteria

Participants who are underweight (BMI < 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McKenzie group	McKenzie group	This group will receive Hand-on technique on the lumbar spine.
Control group	Control group	The Group will not receive Hand-on technique on the lumbar spine.

Primary Outcome Measures

Name	Time	Method
Pain Numerical Rating Scale (PNRS).	Two weeks	For assessing the pain in the low back.

Secondary Outcome Measures

Name	Time	Method
Centralization or non-centralizer (Peripheralization) of patient symptoms.	Two weeks.	Using the body chart.
Spine mobility	Two weeks	In the flexion/extension/rotation and side bending(Right -Left)
Postural alterations.	Two weeks	It is measure by Postural Analysis Grid (PAG) and software
Disability associated with LBP	Two weeks	It is measure by The Oswestry Disability Index (ODI)