Low Back Pain
Conditions
Keywords
low back pain, Exercise Therapy, Pain Measurement, Quality of Life
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.
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.
Interventions
focusing on core stabilization, flexibility, posture, and muscle strength
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.
Sponsors
Uskudar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (Numeric Rating Scale - NRS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional disability (Oswestry Disability Index - ODI) | 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. |
| Health-related quality of life (Short Form-12 Health Survey - SF-12) | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORosman çoban, phd
üsküdar university
Outcome results
None listed