Skip to main content
OpenTrials
Completed

NCT Number: NCT06875921

McKenzie vs Pilates Exercises in People With Chronic Low Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

McKenzie Exercise Group

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 exercise group

Other

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

Primary outcomes

  1. Changes in Low Back Pain (LBP) Intensity Using the Visual Analog Scale (VAS)

    Time frame: Pre-treatment, Post-treatment (Week 3)

    The VAS is a 10 cm pain scale with no numerical markings. The left end represents "No pain," while the right end corresponds to "Worst possible pain." A higher score indicates greater pain intensity. Participants will complete the scale twice-before and after the intervention-marking the level of pain experienced over the past 24 hours. Pain intensity will be quantified by measuring the distance from the zero point ("No pain") to the indicated score

  2. Changes in Pressure Pain Threshold (PPT) Using Pressure Algometry

    Time frame: Pre-treatment, Post-treatment (Week 3)

    Pressure pain threshold (PPT) refers to the minimum amount of pressure required to elicit pain. A digital algometer will be used to measure PPT bilaterally at the L4-L5 intervertebral space. The device's metal rod will be placed perpendicularly on the site, and pressure will be gradually increased at a rate of 1 kg/s until the participant reports pain. PPT will be recorded in N/cm².

  3. Changes in Functional Capacity Using the Greek Version of the Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Pre-treatment, Post-treatment (Week 3)

    Functional capacity will be assessed using the validated Greek version of the Roland-Morris Disability Questionnaire (RMDQ), which consists of 24 items addressing daily activities impacted by low back pain. Each selected statement adds one point to the total score, with higher values indicating greater disability.

  4. 4. Changes in Lumbar Spine Flexion Range of Motion Using the Fingertip-to-Floor (FTF) Test

    Time frame: Pre-treatment, Post-treatment (Week 3)

    Spinal mobility will be evaluated using the Fingertip-to-Floor Test, a widely used clinical tool for assessing trunk flexion. Participants will be asked to bend forward and reach toward the ground while keeping their knees and hips extended. The examiner will measure the vertical distance between the participant's fingertips and the floor using a tape measure.

Sponsors and collaborators

Lead sponsor

International Hellenic University

Other

Registry information

Official study title

Home-Based, Video-Supported McKenzie vs. Pilates Exercise Programs for Individuals With Chronic Low Back Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.