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Completed

NCT Number: NCT03066674

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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Treatment and study plan

McKenzie group

Other

Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.

Control Group

Other

TENS,Exercises,Postural education ,Home exercises program.

Other names: without any Hand -on Technique.

Primary outcomes

  1. Pain Numerical Rating Scale (PNRS).

    Time frame: Two weeks

    For assessing the pain in the low back.

Secondary outcomes

  1. Spine mobility

    Time frame: Two weeks

    In the flexion/extension/rotation and side bending(Right -Left)

  2. Centralization or non-centralizer (Peripheralization) of patient symptoms.

    Time frame: Two weeks.

    Using the body chart.

  3. Postural alterations.

    Time frame: Two weeks

    It is measure by Postural Analysis Grid (PAG) and software

  4. Disability associated with LBP

    Time frame: Two weeks

    It is measure by The Oswestry Disability Index (ODI)

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

Effect of the Hands- on McKenzie Program on Derangement Syndrome in Sub-acute and Chronic Low Back Pain

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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