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

Not Applicable

Completed

• Conditions: Low Back Pain

• Registration Number: NCT06796465
• Lead Sponsor: Riphah International University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-11
• Primary Completion: 2024-12-02
• Status Verified: 2025-01
• Study Completion: 2025-01-10
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NPRS	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
The Roland-Morris Disability Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Inclinometer	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.

Trial Locations

Locations (1)

Shaikh Zayed Hospital; 🇵🇰 Lahore, Punjab, Pakistan