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CompletedNCT03066674Updated Aug 22, 2017

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

An interventional study of McKenzie group and Control group in Low Back Pain, sponsored by Imam Abdulrahman Bin Faisal University. Completed. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2016, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Back Pain
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 38 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Imam Abdulrahman Bin Faisal University is the lead sponsor of 88 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    McKenzie group

    This group will receive Hand-on technique on the lumbar spine.

    Other: McKenzie group

  • Experimental
    Control group

    The Group will not receive Hand-on technique on the lumbar spine.

    Other: Control group

Interventions

  • OtherMcKenzie group

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

  • OtherControl group

    TENS,Exercises,Postural education ,Home exercises program.

    Also known as: without any Hand -on Technique.

06

What researchers measure

Primary outcomes

  1. Pain Numerical Rating Scale (PNRS).

    For assessing the pain in the low back.

    Time frame: Two weeks

Secondary outcomes

  1. Spine mobility

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

    Time frame: Two weeks

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

    Using the body chart.

    Time frame: Two weeks.

  3. Postural alterations.

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

    Time frame: Two weeks

  4. Disability associated with LBP

    It is measure by The Oswestry Disability Index (ODI)

    Time frame: Two weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03066674
Lead sponsor
Imam Abdulrahman Bin Faisal University
Responsible party
Lina Abdullah AL-Banawi (Physical Therapist, Imam Abdulrahman Bin Faisal University) — Principal investigator
First posted
Feb 28, 2017
Start date
Jan 1, 2016
Primary completion
Jan 1, 2017
Completion
Jan 1, 2017
Last update
Aug 22, 2017

Study contacts

LINA A ALBANAWI, MASTER
study chair · Imam Abdulrahman Bin Faisal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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