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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain intensity (Numeric Rating Scale - NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: reformer Pilates exercises (Other)
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.
干预措施: conventional physiotherapy group (Other)
结局指标
主要结局
Pain intensity (Numeric Rating Scale - NRS)
时间窗: 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.
次要结局
- 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)
研究者
osman coban
Asst. Prof.
Uskudar University