Comparing the Effects of Foot Exercise v/s Electrical stimulation on Pain, Quality of Sleep and Community participation in Individuals with Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- 1) VAS score
研究概览
简要总结
The study titled Comparing the Effects of Foot Exercise vs Electrical Stimulation on Pain, Quality of Sleep, and Community Participation in Individuals with Diabetic Peripheral Neuropathy is a randomized controlled trial conducted by Ashmita Ashok Vernekar at SDM College of Physiotherapy, Dharwad, under the guidance of Dr. Salima Mulla Bijapuri. Diabetic Peripheral Neuropathy (DPN) is a common and debilitating complication of type 2 diabetes, leading to pain, sleep disturbances, and reduced functional mobility. The study aims to assess the effectiveness of foot exercises and transcutaneous electrical nerve stimulation (TENS) in reducing pain and improving sleep quality compared to standard diabetic care. Sixty-three participants aged 40 and above, diagnosed with painful DPN, will be randomly assigned to three groups: foot exercises, TENS therapy, and control. Each intervention will be administered three times per week for four weeks. Outcomes will be measured using standardized tools such as the Visual Analogue Scale (VAS), DN4, Pittsburgh Sleep Quality Index (PSQI), Single Leg Stance (SLS) test, and Michigan Neuropathy Screening Instrument (MNSI). The novelty of the study lies in its shorter intervention duration aimed at better adherence and its holistic approach addressing both pain and sleep—two critical yet often neglected aspects of DPN management. The findings are expected to support the use of non-pharmacological interventions like TENS and foot exercises as effective, affordable, and accessible treatment strategies for DPN, potentially improving patient quality of life and setting the foundation for future research in physiotherapy-based diabetic care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Medically stable type 2 diabetes mellitus RBS greater than 200 mg per dl
- •Sharp Pain like tingling or burning sensation in the feet or legs especially at night
- •Pain intensity is more than 3 on VAS and more than 4 on DN
- •Participants diagnosed with peripheral polyneuropathy by the physician
- •Participants willing to sign the informed consent.
排除标准
- •Severe musculoskeletal disorders that impair their participation in exercise.
- •Complete loss of sensation in the feet, especially in the TENS group.
- •Any other neurological disease other than PDN
- •Ulcers, amputation, vascular insufficiency.
- •Presence of severe cardiovascular and respiratory diseases
- •Participants with cognitive disorders.
结局指标
主要结局
1) VAS score
时间窗: The outcome measures will be assessed at two timepoints: initially at baseline before the start of the intervention and then re-evaluated after four weeks of intervention.
2) The DN4 (Douleur Neuropathique 4) scale
时间窗: The outcome measures will be assessed at two timepoints: initially at baseline before the start of the intervention and then re-evaluated after four weeks of intervention.
3) PSQI (Pittsburgh Sleep Quality Index)
时间窗: The outcome measures will be assessed at two timepoints: initially at baseline before the start of the intervention and then re-evaluated after four weeks of intervention.
4) SLS (single leg stance) test
时间窗: The outcome measures will be assessed at two timepoints: initially at baseline before the start of the intervention and then re-evaluated after four weeks of intervention.
次要结局
未报告次要终点
研究者
Ashmita Ashok Vernekar
SDM College of physiotherapy