Effect of Thai Foot Massage on Type 2 Diabetes Peripheral Neuropathy

NCT06066944 | Not Yet Recruiting

• 1 other identifier: Foot Massage RCT 001
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Diabetic Neuropathy

Keywords

Peripheral neuropathy; Thai Foot Massage; Range of Motion; Ipswich Touch Test (IpTT); Somatosensory Reception

Outcome Measures

Primary Outcomes (3)

• Ipswich Touch Test Score (IpTT)

  To measure the somatosensory level, Ipswich Touch Test (IpTT) is a reliable and valid test to assess the sensory deficit in diabetic-related neuropathy patients. The highest score is 6. 6/6 means no neuropathy and 0/6 means worse possible neuropathy.

  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

Study Arms (2)

Group A

EXPERIMENTAL

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

Other: Thai Foot Massage

Group B

NO INTERVENTION

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.

Interventions

Thai Foot Massage 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.

Also known as: Control group will continue with the standard care advised by the physician

Group A

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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."

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Azra Khanum, 1

  PG Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azra Khanum, 1

CONTACT

03328600744; shanji755@gmail.com

Mohammad Younis, 2

CONTACT

03324712073; azrakhanum265@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Participants will be assigned to the intervention and control group randomly.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: January 25, 2025
• Primary Completion: April 25, 2025
• Study Completion: May 10, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share