Effect of Thai Foot Massage on Type 2 Diabetes Peripheral Neuropathy

NCT ID: NCT06066944

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2025-05-10

Brief Summary

The goal of this clinical trial is to examine the effect of Thai-Foot Massage on type 2 diabetes peripheral neuropathy. The main question is to answer the role of massage in improving peripheral neuropathy. Thai Foot Massage will be administered by the researcher every alternate day for 15 days. Researchers will compare the intervention group with the control group (without intervention) to see the improvement in Somatosensory Reception, Range of Motion, and peripheral neuropathy-induced Pain.

Detailed 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 Somatosensory Reception deficit. 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 Thai Foot Massage has immediate and prolonged effects on foot pain, range of motion, and Somatosensory Reception among patients with Type 2 Diabetes Peripheral Neuropathy. This research seeks to determine the impact of 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 by calculating IpTT score ≤ 4/6. The study will be done at the University of Health Sciences in collaboration with the Diabetic Clinic District Headquarters Shiekhupura. 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 27, 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 short, this study aims to enhance our understanding of how Thai Foot Massage can impact pain, range of motion, and somatosensory reception 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.

Conditions

Peripheral Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

The experimental group will receive a Thai Foot Massage every alternate day for 30 minutes for 15 days.

Group Type: EXPERIMENTAL

Thai Foot Massage

Intervention Type: OTHER

It is the application of Massage through specific techniques and pressure to the feet and lower legs to promote relaxation, improve circulation, and enhance overall well-being. It is a traditional therapeutic practice originating from Thailand and is often performed by trained practitioners. Thai foot massage is often based on traditional Thai massage techniques. The researcher is duly certified for the administration of Thai Foot Massage.

Group B

Participants in the control group will continue with the standard treatment regimen prescribed by the physician at the diabetic clinic. Baseline data will be collected as conducted for the experimental group. After the completion of the study, if the intervention will prove effective, the Thai foot massage will be applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thai Foot Massage

It is the application of Massage through specific techniques and pressure to the feet and lower legs to promote relaxation, improve circulation, and enhance overall well-being. It is a traditional therapeutic practice originating from Thailand and is often performed by trained practitioners. Thai foot massage is often based on traditional Thai massage techniques. The researcher is duly certified for the administration of Thai Foot Massage.

Intervention Type: OTHER

Other Intervention Names

Control group will continue with the standard care advised by the physician

Eligibility Criteria

Inclusion Criteria

• Age range, 40 to 65, to ensure a consistent demographic.
• Both genders will be part of the study.
• Participants must have a confirmed medical diagnosis of Type 2 Diabetes by the physician and do not have an ulcer or amputation in either foot.
• A score on the Ipswich touch test less than 4/6 will be included.
• Patients must have a level of glycated hemoglobin HbA1C more than 7.
• Individuals receiving treatment for diabetes mellitus, which may include oral hypoglycemic agents, insulin, or both."

Exclusion Criteria

• Individuals with pre-existing neurological conditions unrelated to diabetes or peripheral neuropathy.
• Participants having severe diabetic complications such as advanced nephropathy, retinopathy or vascular disease will not be included in the study.
• Individuals with foot ulcers, infections, or any medical conditions that prevent them from receiving foot massage safely

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Azra Khanum

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azra Khanum, 1

Role: PRINCIPAL_INVESTIGATOR

PG Nursing

Central Contacts

Azra Khanum, 1

Role: CONTACT

shanji755@gmail.com

03328600744

Mohammad Younis, 2

Role: CONTACT

azrakhanum265@gmail.com

03324712073

Other Identifiers

Foot Massage RCT 001

Identifier Type: -

Identifier Source: org_study_id