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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066674
• Other study ID #: 2015-03-178
• Status: Completed
• Phase: N/A
• First received: February 23, 2017
• Last updated: August 18, 2017
• Start date: January 1, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: August 2017
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• McKenzie group
Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.
• Control group
TENS,Exercises,Postural education ,Home exercises program.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Numerical Rating Scale (PNRS).	For assessing the pain in the low back.	Two weeks
Secondary	Spine mobility	In the flexion/extension/rotation and side bending(Right -Left)	Two weeks
Secondary	Centralization or non-centralizer (Peripheralization) of patient symptoms.	Using the body chart.	Two weeks.
Secondary	Postural alterations.	It is measure by Postural Analysis Grid (PAG) and software	Two weeks
Secondary	Disability associated with LBP	It is measure by The Oswestry Disability Index (ODI)	Two weeks