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Набор скоро начнётся NCT06066944

Effect of Thai Foot Massage on Type 2 Diabetes Peripheral Neuropathy

Без фазы С лечением Peripheral Diabetic Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Thai Foot Massage.
Кому может быть актуально
Состояния в реестре: Peripheral Diabetic Neuropathy. Базовые параметры: 40 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Ipswich Touch Test Score (IpTT) [Срок оценки: 1 Months]
  • Measure the Range of Motion [Срок оценки: 1 Months]
  • Measure the intensity of neuropathy induced pain [Срок оценки: 1 Month]

Критерии участия

Критерии включения

  • 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."

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06066944 · Foot Massage RCT 001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗