Low Back PainNCT07543952
Reformer Pilates vs Conventional Physiotherapy in Chronic Low Back Pain
A study testing reformer Pilates exercises and conventional physiotherapy group in people with Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- reformer Pilates exercises and conventional physiotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 30 Apr 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- reformer Pilates exercises, conventional physiotherapy group
- Keywords
- low back pain, Exercise Therapy, Pain Measurement, Quality of Life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reformer Pilates exercisesOther
Also called Reformer Pilates exercises targeting core stabilization, trunk control, and flexibility.
focusing on core stabilization, flexibility, posture, and muscle strength
conventional physiotherapy groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group (PG) | Experimental | 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. Receives: Other: reformer Pilates exercises |
| Conventional Physiotherapy Group | Active comparator | 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. Receives: Other: conventional physiotherapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (Numeric Rating Scale - NRS)
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.
Measured: Change from baseline to 6 weeks
Secondary outcomes (2)
Functional disability (Oswestry Disability Index - ODI)
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.
Measured: Change from baseline to 6 weeks
Health-related quality of life (Short Form-12 Health Survey - SF-12)
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.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start28 Feb 2026
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Uskudar University
- Investigators
- osman çoban, phd, Principal investigator, üsküdar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543952
- Sponsor's protocol ID
- uskudarulumbarpilates
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29651872Miyamoto 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.
PubMed 24346291Wells 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.
PubMed 24984069
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07543952
- Acronym / sponsor ID
- uskudarulumbarpilates
- Conditions
- Low Back Pain
- Keywords
- low back pain, Exercise Therapy, Pain Measurement, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 22 Apr 2026 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pilates Group (PG) | Experimental | Other: reformer Pilates exercisesParticipants 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. |
| Conventional Physiotherapy Group | Active comparator | Other: conventional physiotherapy groupParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| reformer Pilates exercisesAlso: Reformer Pilates exercises targeting core stabilization, trunk control, and flexibility.focusing on core stabilization, flexibility, posture, and muscle strength | Other | Pilates Group (PG) |
| conventional physiotherapy groupParticipants 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. | Other | Conventional Physiotherapy Group |
Primary outcome
Pain intensity (Numeric Rating Scale - NRS)
Time frame: Change from baseline to 6 weeks
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.
2 secondary outcomes
Functional disability (Oswestry Disability Index - ODI)
Time frame: Change from baseline to 6 weeks
Health-related quality of life (Short Form-12 Health Survey - SF-12)
Time frame: Baseline and after 6 weeks of intervention
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 26 Jun 2026.
- Results publication: PubMed 29651872Cruz-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.
- Results publication: PubMed 24346291Miyamoto 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.
- Results publication: PubMed 24984069Wells 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.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
osman çoban, phd principal investigator
üsküdar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reformer Pilates exercises and conventional physiotherapy group in people with Low Back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 26 Jun 2026. 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 Turkey (Türkiye). 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?
Pain intensity (Numeric Rating Scale - NRS) (time frame: Change from baseline to 6 weeks). 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 NCT07543952, which also lists 3 linked publications.
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 26 Jun 2026.