McKenzie vs Pilates Exercises in People With Chronic Low Back Pain

NCT06875921 | Completed

• 1 other identifier: EC-7 2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain; Pilates; McKenzie; Physiotherapy; Home-based exercise

Outcome Measures

Primary Outcomes (4)

• 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.

  Pre-treatment, Post-treatment (Week 3)

Study Arms (2)

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

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.

McKenzie Exercises

Pilates Exercise Group OTHER

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

Pilates Exercises

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Thessaloniki, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A masked assessor will conduct the measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: March 10, 2025
• Primary Completion: April 20, 2025
• Study Completion: April 20, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)