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

Peripheral Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06066944
• Other study ID #: Foot Massage RCT 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 25, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Health Sciences Lahore
• Contact: Azra Khanum, 1
• Phone: 03328600744
• Email: shanji755[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to examine the effect of Self-Thai Foot Massage on 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 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.

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. 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 Somatosensory Reception 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: December 1, 2024
• Est. primary completion date: September 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Diabetic Neuropathy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Health Sciences Lahore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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