McKenzie vs Pilates Exercises in People With Chronic Low... | NCT06875921

NCT06875921

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
McKenzie Exercises	Experimental	Participants allocated to this group will perform exercises based on the McKenzie Method at home, once a day for three weeks.	Other: McKenzie Exercise Group
Pilates Exercises	Experimental	Participants allocated to this group will perform exercises based on the Pilates Method at home, twice a week for three weeks.	Other: Pilates Exercise Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in Low Back Pain (LBP) Intensity Using the Visual Analog Scale (VAS)	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	Pre-treatment, Post-treatment (Week 3)
Changes in Pressure Pain Threshold (PPT) Using Pressure Algometry	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.	Pre-treatment, Post-treatment (Week 3)
Changes in Functional Capacity Using the Greek Version of the Roland-Morris Disability Questionnaire (RMDQ)	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.	Pre-treatment, Post-treatment (Week 3)
4. Changes in Lumbar Spine Flexion Range of Motion Using the Fingertip-to-Floor (FTF) Test	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.

Eligibility Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41316625	Derived	Zygouna L, Lytras D, Kasimis K, Chatziprodromidou IP, Apostolou T, Iakovidis P. Comparison of the effectiveness of home-based video-supported McKenzie versus Pilates exercise programs in patients with chronic non-specific low back pain: a randomized controlled trial. J Bodyw Mov Ther. 2025 Dec;45:598-605. doi: 10.1016/j.jbmt.2025.09.044. Epub 2025 Sep 29.