Clinical trial NCT06066944: Effect of Thai Foot Massage on Type 2 Diabetes Peripheral Neuropathy
Official title: Immediate and Prolonged Effects of Thai Foot Massage on Pain, Range of Motion and Somatosensory Reception Among Patients With Type 2 Diabetes Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peripheral Diabetic Neuropathy
Keywords: Peripheral neuropathy
Thai Foot Massage
Range of Motion
Ipswich Touch Test (IpTT)
Somatosensory Reception
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 78
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to the intervention and control group randomly.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Ipswich Touch Test Score (IpTT)
timeFrame: 1 Months
measure: Measure the Range of Motion
timeFrame: 1 Months
measure: Measure the intensity of neuropathy induced pain
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PG Nursing
name: Azra Khanum, 1
role: PRINCIPAL_INVESTIGATOR
References: