Effects of Self-Thai Foot Massage on Pain, Range of Motion and Functional Disability in Type 2 DM

Immediate and Prolonged Effects of Self-Thai Foot Massage on Pain, Range of Motion and Functional Disability Among Patients With Type 2 Diabetes Peripheral Neuropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Diabetic Neuropathy
• Intervention / Treatment: Other: Self-Thai Foot Massage

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 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 Type: Interventional
• Enrollment (Estimated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azra Khanum, 1; Phone Number: 03328600744; Email: shanji755@gmail.com
• Study Contact Backup: Name: Mohammad Younis, 2; Phone Number: 03324712073; Email: azrakhanum265@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have a confirmed medical diagnosis of Type 2 Diabetes by the physician.
• Patients with (Foot and ankle Disability Index) FADI score of less than 80 will be included.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group B; The experimental group will receive a Self-Thai Foot Massage on every alternate day for 15 days for 30 minutes.	Other: Self-Thai Foot Massage; It is a specific technique 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. Self-Thai foot massage is often based on traditional Thai massage techniques but adapted for self-application.; Other Names: Control group will continue with the standard care advised by the physician
No Intervention: Group A; 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 Self-Thai foot massage will be taught to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure the level of Foot and Ankle Disability Index	Functional disability refers to the limitations or difficulties experienced by patients with type 2 diabetes and peripheral neuropathy in performing daily activities. It will be evaluated using standardized assessment tools The Foot & Ankle Disability Index (FADI) Score This tool consists of a series of questions related to various functional activities, and patients will provide responses indicating the extent to which their condition affects their ability to perform each activity, ranging from no difficulty to extreme difficulty. The FADI is scored out of 104, with a score of 0 indicating maximum disability and a score of 104 indicating no disability.; A FADI score ranging from 80% to 104% of the maximum possible score is considered indicative of mild disability; A FADI score between 50% and 79% of the maximum possible score is often categorized as an irate disability; FADI score below 50% of the maximum possible score is generally indicative of severe disability.	1 Months
Measure the Range of Motion	Range of motion refers to the extent of movement that can be achieved at a specific joint. In this study, the range of motion of the foot and ankle joints will be measured using goniometry, a technique that involves using a universal goniometer to measure the angles of joint movement. ROM will be assessed for the ankle joint, in degrees of dorsiflexion and plantarflexion.	1 Months
Measure the intensity of neuropathy induced pain	Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, reported by patients. In this study pain refers to the unpleasant sensations caused by type 2 diabetes peripheral neuropathy. Pain will be measured through numeric rating pain scale, which ranges from 0 to 10, where "0" represent No Pain and 10 represent worse possible pain. Pain can categorize according to pain score. Mild pain: A score of 1 to 3 Moderate Pain: A score of 4 to 6. Severe Pain: A score of 7 to 10.	1 Month

Collaborators and Investigators

• Sponsor: University of Health Sciences Lahore
• Investigators: Principal Investigator: Azra Khanum, 1, PG Nursing

Study record dates

Study Major Dates

• Study Start (Estimated): February 25, 2024
• Primary Completion (Estimated): April 25, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 4, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Range of Motion; Peripheral neuropathy; Foot and Ankle Disability Index; Selt-Thai Foot Massage
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: Foot Massage RCT 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No