Clinical trial NCT06796465: McKenzie Protocol With/Without Postural Control Exercises on Pain, ROM, and Disability in Low Back Pain
Official title: Effects of Mckenzie Protocol With and Without Progressive Postural Control Exercise on Pain, Range of Motion and Disability in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
McKenzie exercise
Progressive postural control exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: NPRS
timeFrame: Baseline, 3 and 6 weeks
measure: The Roland-Morris Disability Questionnaire
timeFrame: Baseline, 3 and 6 weeks
Secondary outcomes:
measure: Inclinometer
timeFrame: Baseline, 3 and 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Humera Mubashar, MS OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang H, Fan Z, Liu X, Zheng J, Zhang S, Zhang S, Yu Q, Lo WLA, Chen X, Wang C. Effect of Progressive Postural Control Exercise Versus Core Stability Exercise in Young Adults with Chronic Low Back Pain: A Randomized Controlled Trial. Pain Ther. 2023 Feb;12(1):293-308. doi: 10.1007/s40122-022-00458-x. Epub 2022 Dec 1.