McKenzie Protocol With/Without Postural Control Exercises on Pain, ROM, and Disability in Low Back Pain

January 22, 2025 updated by: Riphah International University

Effects of Mckenzie Protocol With and Without Progressive Postural Control Exercise on Pain, Range of Motion and Disability in Patients With Low Back Pain

Chronic Low Back Pain (CLBP) is a prevalent global musculoskeletal disorder associated with significant physical, psychosocial, and economic burdens. The McKenzie method focuses on the use of sustained postures or repeated movements tailored to alleviate pain and restore function. Progressive Postural Control Exercise (PPCE) is an innovative approach for managing CLBP. It combines elements of motor control exercises and resistance training, emphasizing challenges to postural control through phased progression to improve stability and function.

The aim of this study is to compare the effects of the McKenzie protocol, both with and without the integration of Progressive Postural Control Exercises (PPCE), on pain, range of motion, and disability in patients with low back pain.

This study utilized a randomized controlled design with two groups. Participants were recruited from Shaikh Zaid Hospital using non-probability convenience sampling. The intervention lasted six weeks, with assessments conducted at baseline, three weeks, and six weeks.

Group A received McKenzie exercises combined with Progressive Postural Control Exercises (PPCE), while Group B was treated with McKenzie exercises alone, without PPCE. Assessment tools included the Numeric Pain Rating Scale (NPRS) for pain, the Roland-Morris Disability Questionnaire (RMDQ) for disability, the Oswestry Disability Index (ODI) for disability, and an inclinometer for measuring range of motion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Shaikh Zayed Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-65 years
  • Diagnosed with non-specific low back pain, with symptoms and pain persisting for over 3 months
  • Individuals reporting a pain intensity of at least 4 out of 7 on the 11-point Numeric Pain Rating Scale (11-NPRS)
  • Individuals scoring 4 or above on the Roland-Morris Questionnaire (RMQ) for low back pain

Exclusion Criteria:

  • Pregnancy
  • Chronic low back pain (LBP) due to trauma, structural issues, neurological symptoms, or radiating pain to the lower legs
  • History of back surgery, spinal tumors, or infections
  • Diagnosed neurological or musculoskeletal disorders unrelated to LBP, including, Stroke, Parkinson's disease, Demyelination disorders, Multiple sclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A received a combination of McKenzie exercises and Progressive Postural Control Exercises. Each session began with the application of hot packs for 10-15 minutes to prepare the patients for the exercises. Patients then performed three sets of three exercises, with 10 repetitions per set, lasting approximately 10-15 minutes in total.
Device: Hot Pack
for 10 to 15 minutes
Other: McKenzie with Progressive Postural Control Exercises

The McKenzie Exercises focus on progressive spinal extension to alleviate back pain. Key steps include Extension in Standing, where patients lean backward and return to a neutral stance; Extension in Lying (Partial Range), involving partial pushups in a prone position; and Extension in Lying (Full Range), where patients fully extend their arms to achieve maximum spinal extension. Each movement is held for 1-2 seconds.

The PPCE program enhances core strength and stability through three stages. In the First Stage (2 weeks), core muscles are trained against gravity using movements like pelvic retroversion, crunches, and glute bridges. The Second Stage (3 weeks) incorporates a Swiss ball to challenge trunk muscles with instability. In the Third Stage (3 weeks), a Swiss ball, stretch bands, and a 5 kg sandbag are used to increase complexity on unstable surfaces. Each stage includes six movements, lasting 5 minutes each, for a total session duration of 30 minutes.

Other Names:
  • McKenzie
  • Progressive Postural Control
Experimental: Group B
Group B was treated with McKenzie exercises without the integration of Progressive Postural Control Exercises. Each session began with the application of hot packs for 10-15 minutes to prepare the patients for the technique. Patients then performed three sets of three exercises, with 10 repetitions per set, lasting approximately 10-15 minutes in total.
Device: Hot Pack
for 10 to 15 minutes
Other: McKenzie without Progressive Postural Control Exercises

Subject were treated with McKenzie exercises without the addition of Progressive Postural Control Exercises (PPCE).The exercises included the following:

Standing Extension Exercises: Patients leaned backward from a balanced standing position, arching their back before returning to a neutral stance.

Extension in Lying (Partial Range): Performed in a prone position with hands placed under the shoulders, patients lifted their upper torso in a motion similar to a push-up.

Extension in Lying (Full Range): Similar to the partial range extension, but with fully extended arms, aiming for the maximum tolerated extension. Each movement was sustained for 1-2 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPRS
Time Frame: Baseline, 3 and 6 weeks
The Numeric Pain Rating Scale (NPRS) will be used to assess patients' pain levels for chronic low back pain both before and after the exercises. This 11-point numeric scale ranges from 0, representing no pain (e.g., "no pain at all"), to 10, representing the worst pain imaginable (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS demonstrates strong validity, with values ranging from 0.86 to 0.96
Baseline, 3 and 6 weeks
The Roland-Morris Disability Questionnaire
Time Frame: Baseline, 3 and 6 weeks
The Roland-Morris Disability Questionnaire (RMDQ) is a reliable and widely used tool for assessing disability in patients with low back pain. Its updated applications and adaptations have reinforced its validity across diverse patient populations and healthcare settings. The RMDQ consists of 24 items, with the total score calculated by summing the responses. A "yes" response is scored as 1, and a "no" response is scored as 0, resulting in a total score range of 0 to 24. This range reflects the level of disability, with higher scores indicating greater disability in individuals with low back pain.
Baseline, 3 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inclinometer
Time Frame: Baseline, 3 and 6 weeks
The inclinometer is a widely used tool in clinical and research settings for measuring the range of motion (ROM) in spinal, cervical, and limb assessments. It is particularly valuable in managing conditions such as thoracic kyphosis and general musculoskeletal dysfunction. The device demonstrates excellent reliability, with inter-rater correlation coefficients (ICC) around 0.96, indicating high agreement and consistency between different raters.
Baseline, 3 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Humera Mubashar, MS OMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2024

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

January 10, 2025

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/24/0122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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