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

NCT06796465 | Completed

• 1 other identifier: REC/RCR & AHS/24/0122
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Low back pain; McKenzie exercise; Progressive postural control exercise

Outcome Measures

Primary Outcomes (2)

• NPRS

  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

  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 Outcomes (1)

• Inclinometer

  Baseline, 3 and 6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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.

Other: McKenzie with Progressive Postural Control Exercises; Device: Hot Pack

Group B

EXPERIMENTAL

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.

Other: McKenzie without Progressive Postural Control Exercises; Device: Hot Pack

Interventions

McKenzie with Progressive Postural Control Exercises OTHER

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.

Also known as: McKenzie, Progressive Postural Control

Group A

McKenzie without Progressive Postural Control Exercises OTHER

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.

Group B

Hot Pack DEVICE

for 10 to 15 minutes

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Shaikh Zayed Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36454387 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Humera Mubashar, MS OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 11, 2024
• Primary Completion: December 2, 2024
• Study Completion: January 10, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)