Chronic Low Back PainNCT06875921
McKenzie vs Pilates Exercises in People With Chronic Low Back Pain
A study testing McKenzie Exercise Group and Pilates Exercise Group in people with Chronic Low Back Pain, run by International Hellenic University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- McKenzie Exercise Group and Pilates Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGreece
- Study dates
- 10 Mar 2025to 20 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
Thessaloniki
About this study
Official title: Home-Based, Video-Supported McKenzie vs. Pilates Exercise Programs for Individuals 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.
Read the 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
- Being tested
- McKenzie Exercise Group, Pilates Exercise Group
- Keywords
- Chronic low back pain, Pilates, McKenzie, Physiotherapy, Home-based exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie Exercise GroupOther
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 GroupOther
The intervention will last 20 minutes and will include Pilates exercises focused on mobility and strengthening.
| Study group | Role | What they receive |
|---|---|---|
| McKenzie Exercises | Experimental | Participants allocated to this group will perform exercises based on the McKenzie Method at home, once a day for three weeks. Receives: 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. Receives: Other: Pilates Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, Post-treatment (Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start10 Mar 2025
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875921
- Sponsor's protocol ID
- EC-7 2025
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41316625
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based, Video-Supported McKenzie vs. Pilates Exercise Programs for Individuals With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06875921
- Acronym / sponsor ID
- EC-7 2025
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Pilates, McKenzie, Physiotherapy, Home-based exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McKenzie Exercises | Experimental | Other: McKenzie Exercise GroupParticipants allocated to this group will perform exercises based on the McKenzie Method at home, once a day for three weeks. |
| Pilates Exercises | Experimental | Other: Pilates Exercise GroupParticipants allocated to this group will perform exercises based on the Pilates Method at home, twice a week for three weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Neuropathic pain extending along the lower limb due to nerve root compression
- Previous spine surgery
- History of spine trauma or fracture
- Implanted pacemakers
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McKenzie Exercise GroupThe 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. | Other | McKenzie Exercises |
| Pilates Exercise GroupThe intervention will last 20 minutes and will include Pilates exercises focused on mobility and strengthening. | Other | Pilates Exercises |
Primary outcome
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
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.
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. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Derived from this study: PubMed 41316625Zygouna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McKenzie Exercise Group and Pilates Exercise Group in people with Chronic Low Back Pain, run by International Hellenic University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Low Back Pain (LBP) Intensity Using the Visual Analog Scale (VAS) (time frame: Pre-treatment, Post-treatment (Week 3)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875921, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.