A Comparative study to find the effectiveness of myofascial release over conventional exercise on calif muscle pain and functional activities in diabetic neuropathy patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Calf Muscle Pain
研究概览
简要总结
Aim
To evaluate and compare the effectiveness of myofascial release therapy and conventional exercise in improving calf muscle function, reducing pain intensity, and enhancing functional mobility in individuals with diabetic neuropathy.
Primary Objective
• To compare the effectiveness of myofascial release and conventional exercise in improving calf muscle function (strength, flexibility, and range of motion) in individuals with diabetic neuropathy.
Secondary Objectives
To evaluate the impact of myofascial release versus conventional exercise on pain intensity in the calf muscles, as measured by the Visual Analog Scale (VAS).
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To assess the changes in functional mobility using the Timed Up and Go (TUG) test in both intervention groups.
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To determine the effects of the interventions on muscle stiffness and tension in the calf muscles.
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To analyze participant-reported satisfaction and perceived benefits of each intervention.
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To investigate the potential role of myofascial release and conventional exercise in reducing the risk of falls and improving balance in individuals with diabetic neuropathy.
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To compare the long-term sustainability of the functional and pain-relief benefits provided by the two interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 30-70 years diagnosed with type 2 diabetes mellitus.
- •Confirmed diagnosis of diabetic neuropathy (based on clinical tests like Michigan Neuropathy Screening Instrument or nerve conduction studies).
- •Presence of calf muscle dysfunction, including symptoms such as pain, stiffness, reduced strength, or limited range of motion.
- •Pain intensity in the calf region rated as greater than 4 on the Numeric Pain Rating Scale(NRS).
- •Ability to walk independently or with minimal assistance.
- •Willingness to participate and provide written informed consent.
排除标准
- •1 Diagnosis of type 1 diabetes or other non-diabetic neuropathies 2 Presence of severe peripheral arterial disease ankle-branchial index is lesser than 0.7 3 History of lower limb fractures surgeries or conditions like Achilles tendonitis or plantar fasciitis in the past 6 months 4 Severe musculoskeletal disorders affecting the lower limbs arthritis or joint deformities 5 Any coexisting neurological conditions eg stroke multiple sclerosis) that may interfere with functional assessment 6 Active foot ulcers, infections, or other diabetic foot complications 7 Use of opioids or other strong analgesics that may alter pain perception during the study period.
- •Participation in another clinical trial or physical therapy program in the last 3 months.
- •Pregnancy or lactation.
结局指标
主要结局
Calf Muscle Pain
时间窗: Calf Muscle Function | Improvement in muscle strength, as measured by a handheld dynamometer. | Increased range of motion (ROM) in the ankle joint, assessed using a | goniometer. | Enhanced flexibility of the calf muscles, as determined by standard flexibility | Tests.
次要结局
- 1 To evaluate the impact of myofascial release versus conventional exercise on pain intensity in the calf muscles, as measured by the Numeric Pain Rating Scale NRS(2 To assess the changes in functional activity using the Lower Extremity Functional Scale LEFS in both intervention groups)
- Improvement in muscle strength, as measured by a handheld dynamometer.(Increased range of motion (ROM) in the ankle joint, assessed using a)
研究者
SARAVANAN
Dr MGR Educational and Research Institute