- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543952
Reformer Pilates vs Conventional Physiotherapy in Chronic Low Back Pain
Comparison of Reformer Pilates Exercises and Conventional Physiotherapy on Pain, Disability and Quality of Life in Individuals With Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial
Non-specific chronic low back pain is one of the most prevalent musculoskeletal disorders worldwide and is associated with functional limitations and reduced quality of life. Exercise-based physiotherapy approaches are strongly recommended in clinical guidelines. Pilates exercises are frequently used due to their potential effects on core stability and movement control, while conventional physiotherapy remains a commonly applied treatment method. However, randomized controlled trials directly comparing these interventions are limited.
This study aims to compare the short-term effects of reformer Pilates exercises and conventional physiotherapy on pain intensity, functional disability and health-related quality of life in individuals with non-specific chronic low back pain.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a prospective randomized controlled trial with two parallel groups. Participants meeting eligibility criteria will be randomly allocated to reformer Pilates or conventional physiotherapy groups using computer-generated randomization.
Both groups will receive treatment three times per week for six weeks. The reformer Pilates program will focus on trunk stabilization, coordination and flexibility. The conventional physiotherapy program will include electrotherapy modalities and therapeutic exercises.
Participants will be evaluated before and after the intervention. Primary outcome will be pain severity measured by NRS. Secondary outcomes will include functional disability measured by ODI and quality of life assessed by SF-12.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: osman çoban, phd
- Phone Number: 00905337242919
- Email: oscoban28@gmail.com
Study Contact Backup
- Name: kübra uslu, msc
- Email: fzt.kubrauslu@gmail.com
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Uskudar University
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Principal Investigator:
- osman çoban, phd
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Contact:
- kübra uslu, msc
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Sub-Investigator:
- kübra uslu, msc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Individuals aged between 18 and 65 years
- Diagnosis of non-specific chronic low back pain lasting at least 12 weeks
- Average low back pain intensity ≥3 on the Numeric Rating Scale (NRS) during the last week
- Ability to participate in exercise sessions three times per week
- Providing written informed consent
Exclusion Criteria:
- Specific causes of low back pain (tumor, infection, inflammatory rheumatic disease, vertebral fracture)
- Radiculopathy or significant neurological deficits (progressive motor loss, severe sensory deficit, cauda equina syndrome)
- History of lumbar spine surgery within the past 6 months or current surgical indication
- Participation in regular Pilates or structured exercise programs within the last 3 months
- Severe cardiopulmonary disease or uncontrolled hypertension contraindicating exercise
- Pregnancy or early postpartum period
- Severe psychiatric or cognitive disorders affecting study compliance
- Participation in another physiotherapy or rehabilitation program during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Pilates Group (PG)
Participants in the Pilates group received a structured reformer Pilates exercise program aimed at improving trunk stabilization, neuromuscular control, flexibility, and postural alignment, based on previously published protocols for chronic low back pain.
The intervention was performed three times per week for six weeks (18 sessions), with each session lasting approximately 60 minutes under the supervision of a physiotherapist certified in clinical Pilates.
Each session consisted of a 10-minute warm-up, 40-minute reformer-based core stabilization and motor control exercises, and a 10-minute cool-down phase.
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focusing on core stabilization, flexibility, posture, and muscle strength
Other Names:
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Active Comparator: Conventional Physiotherapy Group
Participants in the conventional physiotherapy group received a standardized program including electrotherapy (hot pack, TENS, ultrasound) and supervised therapeutic exercises (stretching, strengthening, and lumbar stabilization).
The intervention was applied three times weekly for six weeks (18 sessions, 60 minutes/session) with progression based on patient tolerance.
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Participants in the conventional physiotherapy group will receive a structured physiotherapy program consisting of electrotherapy modalities and therapeutic exercises.
The treatment program will include superficial heat therapy, transcutaneous electrical nerve stimulation (TENS), and therapeutic ultrasound based on individual clinical needs.
This will be followed by supervised stretching, strengthening, and lumbar stabilization exercises designed to improve trunk control and functional performance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity (Numeric Rating Scale - NRS)
Time Frame: Change from baseline to 6 weeks
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The primary outcome of the study is pain intensity measured using the Numeric Rating Scale (0-10).
Higher scores indicate greater pain severity.
Change in pain intensity from baseline to post-intervention will be analyzed.
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Change from baseline to 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional disability (Oswestry Disability Index - ODI)
Time Frame: Change from baseline to 6 weeks
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Functional disability will be assessed using the Oswestry Disability Index (ODI), a validated questionnaire consisting of 10 sections evaluating limitations in daily activities due to low back pain.
Scores range from 0 to 100, with higher scores indicating greater disability.
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Change from baseline to 6 weeks
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Health-related quality of life (Short Form-12 Health Survey - SF-12)
Time Frame: Baseline and after 6 weeks of intervention
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Health-related quality of life measured by the Short Form-12 (SF-12) The Short Form-12 assesses physical and mental health domains and provides two summary scores: the Physical Component Summary (PCS) and Mental Component Summary (MCS).
Scores typically range from 0 to 100, with higher scores indicating better health-related quality of life.
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Baseline and after 6 weeks of intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: osman çoban, phd, Uskudar University
Publications and helpful links
General Publications
- Cruz-Diaz D, Romeu M, Velasco-Gonzalez C, Martinez-Amat A, Hita-Contreras F. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil. 2018 Sep;32(9):1249-1257. doi: 10.1177/0269215518768393. Epub 2018 Apr 13.
- Miyamoto GC, Costa LO, Cabral CM. Efficacy of the Pilates method for pain and disability in patients with chronic nonspecific low back pain: a systematic review with meta-analysis. Braz J Phys Ther. 2013 Nov-Dec;17(6):517-32. doi: 10.1590/S1413-35552012005000127.
- Wells C, Kolt GS, Marshall P, Hill B, Bialocerkowski A. The effectiveness of Pilates exercise in people with chronic low back pain: a systematic review. PLoS One. 2014 Jul 1;9(7):e100402. doi: 10.1371/journal.pone.0100402. eCollection 2014.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- uskudarulumbarpilates
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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