McKenzie vs Pilates Exercises in People With Chronic Low Back Pain

NCT ID: NCT06875921

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2025-04-20

Brief Summary

Brief Summary: Chronic low back pain (CLBP) is a persistent condition lasting more than 12 weeks, often leading to pain, disability, and reduced quality of life. This clinical study aims to compare the effectiveness of McKenzie and Pilates exercise programs in managing CLBP symptoms. A total of 32 participants will be randomly assigned to two equal groups: one performing McKenzie exercises and the other engaging in Pilates routines. The intervention will span three weeks. Outcomes will be assessed using the Visual Analogue Scale (VAS) for pain intensity, the Roland-Morris Disability Questionnaire (RMDQ) for functional impairment, a pressure algometer for pain sensitivity (PPT), and the Fingertip-to-Floor test (FTF) for range of motion (ROM). A two-way repeated-measures ANOVA will be used for statistical analysis, with significance set at p < .05.

Detailed Description

Background Chronic low back pain (CLBP) is characterized by persistent pain in the lumbar region lasting for more than 12 weeks, often leading to functional limitations and a decline in quality of life. Exercise-based interventions, such as the McKenzie method and Pilates, are widely implemented in managing CLBP symptoms, but direct comparisons of their effectiveness remain limited.

Aim This study aims to evaluate and compare the effects of the McKenzie method and Pilates exercises on pain relief, functional disability, and range of motion in individuals with CLBP. The objective is to determine whether one approach is more beneficial than the other in alleviating symptoms and enhancing physical function.

Method Thirty-two participants diagnosed with CLBP will be randomly assigned into two equal groups. One group will follow a McKenzie-based exercise program, while the other will engage in a Pilates regimen. Both interventions will last three weeks. Pain intensity will be assessed using the Visual Analogue Scale (VAS), functional disability will be measured with the Roland-Morris Disability Questionnaire (RMDQ), pain sensitivity will be evaluated through the pressure pain threshold (PPT) using an algometer, and range of motion will be determined by the Fingertip-to-Floor (FTF) test. Measurements will be taken before and after the intervention. Statistical analysis will be conducted using a two-way repeated-measures ANOVA to examine within- and between-group differences, with the significance level set at p < .05.

Expected Results This study aims to compare the effectiveness of McKenzie and Pilates exercises in managing CLBP symptoms. Both methods are expected to provide significant improvements in pain reduction, disability, and pain sensitivity. However, since Pilates exercises emphasize flexibility, it is anticipated that they will result in a greater improvement in range of motion compared to the McKenzie method. Consequently, while similar outcomes are expected in most measured parameters, a superior increase in ROM is anticipated in the Pilates group.

Conditions

Chronic Low Back Pain

Study Design

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

Study Groups

McKenzie Exercises

Participants allocated to this group will perform exercises based on the McKenzie Method at home, once a day for three weeks.

Group Type: EXPERIMENTAL

McKenzie Exercise Group

Intervention Type: OTHER

The intervention will last 7 minutes and will consist of the following exercises:

• Four Extension Exercises: Lying Face Down, Lying Face Down in Extension, Repeated Lumbar Extension in Lying, Repeated Lumbar Extension in Standing.
• Two Flexion Exercises: Repeated Lumbar Flexion in Lying, Repeated Lumbar Flexion in Sitting.

Pilates Exercises

Participants allocated to this group will perform exercises based on the Pilates Method at home, twice a week for three weeks.

Group Type: EXPERIMENTAL

Pilates Exercise Group

Intervention Type: OTHER

The intervention will last 20 minutes and will include Pilates exercises focused on mobility and strengthening.

Interventions

McKenzie Exercise Group

The intervention will last 7 minutes and will consist of the following exercises:

• Four Extension Exercises: Lying Face Down, Lying Face Down in Extension, Repeated Lumbar Extension in Lying, Repeated Lumbar Extension in Standing.
• Two Flexion Exercises: Repeated Lumbar Flexion in Lying, Repeated Lumbar Flexion in Sitting.

Intervention Type: OTHER

Pilates Exercise Group

The intervention will last 20 minutes and will include Pilates exercises focused on mobility and strengthening.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Duration of symptoms 12 weeks
• Age range between 18 and 60 years
• Pain score ≥ 2cm in VAS scale
• Written consent to participate in the study

Exclusion Criteria

• Neuropathic pain extending along the lower limb due to nerve root compression
• Previous spine surgery
• History of spine trauma or fracture
• Implanted pacemakers
• Pregnancy
• Cancer
• Systemic musculoskeletal diseases, diagnosed neurodegenerative diseases (e.g., Parkinson's), epilepsy, and history of psychiatric disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Hellenic University

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Lytras

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

EC-7 2025

Identifier Type: -

Identifier Source: org_study_id