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Clinical Trial Summary

The goal of this clinical trial is to examine the effect of Self-Thai Foot Massage in type 2 diabetes peripheral neuropathy. The main question is to answer the role of massage in the improvement of peripheral neuropathy. Participants will be taught to perform the Self-Thai Foot Massage at every alternate day for 15 days. Researchers will compare the intervention group with control group (without intervention) to see the improvement in Foot and Ankle Disability Index, Range of Motion and peripheral neuropathy induced Pain.


Clinical Trial Description

Type 2 diabetes is a chronic metabolic disorder associated with elevated blood sugar levels and various complications, including peripheral neuropathy. This condition damages the nerves controlling sensation, often leading to foot-related issues such as limited range of motion, pain, and functional disabilities. These foot problems pose a significant concern for individuals with diabetes, affecting their overall foot health. Engaging in physical activity programs has been shown to reduce hospitalizations and severe complications in diabetes patients. Foot massage is a specific physical activity aimed at preventing podiatry issues. The study's hypothesis questions whether Self-Thai Foot Massage has immediate and prolonged effects on foot pain, range of motion, and functional disabilities among patients with Type 2 Diabetes Peripheral Neuropathy. This research seeks to determine the impact of Self-Thai Foot Massage on these parameters. Type 2 diabetes and peripheral neuropathy are growing global health concerns and claim a significant social and financial burden. Diabetes Peripheral Neuropathy (DPN) has an impact on quality of life. This study aims to evaluate non-pharmacological interventions to prevent neuropathic complications, including diabetic foot problems and limb amputation. The research design chosen for this study is a Randomized Controlled Trial, recognized for establishing cause-and-effect relationships. The sample will be collected through a non-probability purposive sampling technique and will consist of individuals diagnosed with Type 2 diabetes experiencing peripheral neuropathy symptoms as calculated FADI score ≤ 80. The study will take place at the University of Health Sciences in collaboration with Diabetic Clinic Services Hospital Lahore. A sample size of 78 participants, with a 5% attrition rate, will be divided equally between intervention and control groups using randomization through a lottery method. Statistical analysis will be performed using SPSS version 26, describing categorical variables through frequency and percentage. The association of qualitative data will be assessed with Chi-square, while an independent t-test and repeated measures of ANOVA will compare the two groups and measure time effects for normal data. In summary, this study aims to enhance our understanding of how Self-Thai Foot Massage can impact pain, range of motion, and functional disabilities in patients with Type 2 diabetes and peripheral neuropathy. The findings may offer valuable insights into non-pharmacological interventions for improving foot health in this population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06066944
Study type Interventional
Source University of Health Sciences Lahore
Contact Azra Khanum, 1
Phone 03328600744
Email shanji755@gmail.com
Status Not yet recruiting
Phase N/A
Start date February 25, 2024
Completion date May 1, 2024

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