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临床试验/CTRI/2025/07/090996
CTRI/2025/07/090996尚未招募不适用

Effectiveness of Intraneural Facilitation and Buerger-Allen exercises on Pain and Quality of Life Among Patients with Diabetic Peripheral Neuropathy

Hebsiba P1 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
256
试验地点
1
主要终点
Pain and quality of life

研究概览

简要总结

Diabetic peripheral neuropathy (DPN), a major diabetes complication, is now a leading cause of global disability. DPN causes damage to the nerves in the hands, arms, legs and feet, and it can eventually lead to ulcers, amputation and other long-term disability. "More than 50% of individuals with type 2 diabetes develop DPN symptoms". DPN complications can negatively affect the patient’s quality of life (QOL), with impaired balance, altered gait, and increased pain. Therefore, this study study is to compare the effectiveness of Intraneural Facilitation and Buerger-Allen exercise on Pain and Quality of Life Among Patients with Diabetic Peripheral Neuropathy. A True Experimental design will be used for the study. The study will be carried out in selected OPDs and Physiotherapy unit of Sree Gokulam Medical College & Research Foundation in Thiruvananthapuram district of Kerala. Concealed block sampling will be used to assign the sample in both groups. Study will be conducted by; Step 1: all patients diagnosed with Diabetic Peripheral Neuropathy (DPN) who meets inclusion criteria will be screened for intensity of diabetic peripheral neuropathy by using QOL-DN questionnaire. Those fall under moderate to severe diabetic peripheral neuropathy will be allotted in each block and further randomly assigned in both groups. Step 2: all study participants will be assessed for level of pain, quality of life and clinical parameters at pre-test. Followed by, group 1 will be given 5 weeks intraneural facilitation therapy and group 2 will be given Buerger-Allen exercise. Following therapy, assess the level of pain and quality of life at end of 3rd week of intervention (post-test 1) and level of pain, quality of life,at the end of 5th week of intervention (post-test 2). The collected data will be entered and analysed by using SPSSV.22.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Type 2 Diabetes mellitus patients with below-ankle diabetic peripheral neuropathy symptoms Patients with moderate to severe diabetic peripheral neuropathy.

排除标准

  • Patients with other chronic illness like cancer, renal failure, CLD, COPD Patients with diabetic foot Patients with active inflammation Patients with other neuropathies not associated with DM.

结局指标

主要结局

Pain and quality of life

时间窗: post-test at the end of 3rd week and 5th week. That is, primary outcome will be assessed at baseline (pretest), end of 3rd week (posttest 1) and end of 5th week (posttest 2).

次要结局

未报告次要终点

研究者

发起方
Hebsiba P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Hebsiba P

NITTE Usha Institute of Nursing Sciences

研究点 (1)

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