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NCT Number: NCT07543952

Reformer Pilates vs Conventional Physiotherapy in Chronic Low Back Pain

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

üsküdar University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reformer pilates exercises

Other

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

Other names: Reformer Pilates exercises targeting core stabilization, trunk control, and flexibility.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional disability (Oswestry Disability Index - ODI)

    Time frame: Change from baseline to 6 weeks

    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.

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

    Time frame: Baseline and after 6 weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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