Reformer Pilates vs Conventional Physiotherapy in Chronic Low Back Pain

NCT07543952 | Recruiting

• 1 other identifier: uskudarulumbarpilates
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Low Back Pain

Keywords

low back pain; Exercise Therapy; Pain Measurement; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to 6 weeks

Secondary Outcomes (2)

• Functional disability (Oswestry Disability Index - ODI)

  Change from baseline to 6 weeks

• Health-related quality of life (Short Form-12 Health Survey - SF-12)

  Baseline and after 6 weeks of intervention

Study Arms (2)

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.

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.

Other: conventional physiotherapy group

Interventions

reformer Pilates exercises OTHER

focusing on core stabilization, flexibility, posture, and muscle strength

Also known as: Reformer Pilates exercises targeting core stabilization, trunk control, and flexibility.

Pilates Group (PG)

conventional physiotherapy group OTHER

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.

Conventional Physiotherapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

üsküdar University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 29651872 RESULT

• 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.

  PMID: 24346291 RESULT

• 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.

  PMID: 24984069 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Pliability

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• osman çoban, phd

  üsküdar university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

osman çoban, phd

CONTACT

00905337242919; oscoban28@gmail.com

kübra uslu, msc

CONTACT

fzt.kubrauslu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded to group allocation. However, outcome assessments will be performed by an independent physiotherapist who is blinded to group assignment. Participants will be instructed not to disclose their group allocation to the assessor. Data analysis will be performed using coded group labels to maintain assessor blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: February 28, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)