Effect of comprehensive rehabilitation program on pain, function and disability in Type 2 Diabetes Mellitus individuals with chronic low back pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- • Pressure pain Threshold using algometer
研究概览
简要总结
This study is a randomized controlled trial. Aim of this study is to evaluate the effect of Comprehensive exercise based rehabilitation program on Pain, Function, and Disability in Type 2 Diabetes Mellitus Individuals with Chronic Low Back Pain. Objectives of this study are Phase 1: To profile characteristics of low back pain in Individuals with Type 2 Diabetes Mellitus; Phase 2: To evaluate the effect of comprehensive rehabilitation in Type 2 Diabetes Mellitus individuals suffering from chronic low back pain. There will be 2 groups, intervention group and control group. Intervention group will receive comprehensive exercise based rehabilitation program and control group will receive standard protocol. Comprehensive exercise based rehabilitation program will include pain management using photobiomodulation therapy; pain education and ergonomic advice; and exercise interventions targeting functional restoration and recovery which will include low back exercises, core exercises, lower limb exercises, and ambulation which will include postural exercises, functional strength restoration, flexibility training, lumbar stabilization exercises, neural mobilization, and functional exercises along with standard care. Exercises will be done for 12 weeks. These exercises will be progressed as per speed, resistance, repetition, and difficulty at 4th and 8th week. Control group will receive standard care, moist heat for pain relief and conventional exercises which will include core and low back exercises. Primary outcome measures are Pressure pain Threshold using algometer, Gait analysis using Win-track and Pain using Numeric pain rating scale. Secondary outcome measures are Disability using Oswestry disability index and Soft tissue changes using MRI of low back. Outcomes will be measured at baseline, at 12 weeks and at 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Phase I: Age 18 to 65 years, participants diagnosed with T2DM and on medication from past 1 year, T2DM with or without peripheral neuropathy, HbA1c > 6.4% Phase II: Age 18 to 65 years, history of low back pain LBP> 3 months, Participants diagnosed with Type 2 Diabetes Mellitus and on medication from past 1 year, HbA1c > 6.4%, Numeric pain rating scale >3, Oswestry disability index Score >20%.
排除标准
- •Phase I: Infections or tumors of the spine, systemic bone or joint disorders, neuromuscular pathology, presence of a diagnosed severe psychiatric disorder, confirmed pregnancy, acute disc prolapse, prolapsed Intervertebral disc of other causes, low back pain due to traumatic causes Phase II: Infections or tumors of the spine, systemic bone or joint disorders, unstable cardiovascular and pulmonary diseases, polyneuropathies and musculoskeletal system diseases, presence of a diagnosed severe psychiatric disorder, confirmed pregnancy, any systemic complications which prevents their participation in study.
结局指标
主要结局
• Pressure pain Threshold using algometer
时间窗: Before start of the intervention, at 12 weeks and at 24 weeks after that
• Gait analysis using Win-track
时间窗: Before start of the intervention, at 12 weeks and at 24 weeks after that
• Pain using Numeric pain rating scale
时间窗: Before start of the intervention, at 12 weeks and at 24 weeks after that
次要结局
- • Disability using Oswestry disability index(• Soft tissue changes using MRI of low back)