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

NCT ID: NCT06796465

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-11
• Study Completion Date: 2025-01-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

McKenzie with Progressive Postural Control Exercises

Intervention Type: 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.

Hot Pack

Intervention Type: DEVICE

for 10 to 15 minutes

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.

Group Type: EXPERIMENTAL

McKenzie without Progressive Postural Control Exercises

Intervention Type: 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.

Hot Pack

Intervention Type: DEVICE

for 10 to 15 minutes

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Hot Pack

for 10 to 15 minutes

Intervention Type: DEVICE

Other Intervention Names

McKenzie; Progressive Postural Control

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Humera Mubashar, MS OMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Shaikh Zayed Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 36454387 (View on PubMed)

Other Identifiers

REC/RCR & AHS/24/0122

Identifier Type: -

Identifier Source: org_study_id