CompletedNot Applicable

McKenzie vs Pilates Exercises in People With Chronic Low Back Pain

Greece32 participantsStarted 2025-03-10

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Pre-treatment, Post-treatment (Week 3)

Changes in Pressure Pain Threshold (PPT) Using Pressure Algometry

Timeframe: Pre-treatment, Post-treatment (Week 3)

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

Timeframe: Pre-treatment, Post-treatment (Week 3)

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

Timeframe: Pre-treatment, Post-treatment (Week 3)

Trial details

NCT IDNCT06875921

SponsorInternational Hellenic University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-20

View on ClinicalTrials.gov More Chronic Low Back Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Pre-treatment, Post-treatment (Week 3)

Changes in Pressure Pain Threshold (PPT) Using Pressure Algometry

Timeframe: Pre-treatment, Post-treatment (Week 3)

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

Timeframe: Pre-treatment, Post-treatment (Week 3)

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

Timeframe: Pre-treatment, Post-treatment (Week 3)