The Effect of Acupressure on Symptoms in Elderly Adults With Painful Diabetic Neuropathy

Официальное название

Evaluation of the Effect of Acupressure Applied to Older Adults With Painful Diabetic Peripheral Neuropathy on Neuropathic Symptoms, Balance Confidence, Fear of Falling, and Quality of Life:

Обзор

This project aims to evaluate the effects of acupressure applied to elderly individuals with painful diabetic peripheral neuropathy (DPN) on neuropathic symptoms, balance confidence, fear of falling, and quality of life. This project will be conducted using a mixed methodology integrating quantitative and qualitative methods. Elderly individuals will be randomly assigned to an acupressure or placebo control group. The acupressure group will receive a total of 10 sessions of acupressure over one month. Outcome measures include assessments of neuropathic pain and symptoms, balance confidence, fear of falling, and quality of life. Appropriate statistical tests will be used to analyze the quantitative data obtained from the study, while content analysis will be used for the qualitative data.

Подробное описание

To avoid ignoring the increasing disease burden, decreased productivity, and other problems of elderly individuals, it is important to carefully consider GETAT (Traditional and Complementary Medicine) approaches that may be beneficial in controlling their multiple symptoms in this specific group.

This study aims to evaluate the effect of acupressure on neuropathic symptoms, balance confidence, fear of falls, and quality of life in elderly individuals with Painful Diabetic Peripheral Neuropathy (PDN).

This research will be conducted at Niğde Training and Research Hospital. The research population consists of individuals who participate in planned visits to the Internal Medicine outpatient clinics of Niğde Training and Research Hospital, have a prior diagnosis of DM, and have been diagnosed with DPN by a specialist physician.

Individuals in the acupressure group will participate in a program consisting of a total of 10 sessions over one month. Each session will consist of preparation, application, and termination steps.

The acupuncture points to be applied in this research were determined by an experienced acupuncture specialist and the researcher, according to GETAT methods and in line with the literature.

The number, duration, frequency, and application protocol of sessions in the placebo-acupressure group will be the same as in the acupressure group. The only difference between the two groups is the location of the points.

The study will be conducted in accordance with the 1964 Helsinki Declaration. Research will commence after the purpose and methodology of the study are explained to the participants, anonymity and confidentiality are guaranteed, their willingness to participate is confirmed, and participants provide their BOGs (Brain Stability Questionnaire).

Outcome measures include assessment of neuropathic pain and symptoms, balance confidence, fear of falling, and quality of life. Appropriate statistical tests will be used to analyze quantitative data, and content analysis will be used for qualitative data.

Вмешательства

• Другое acupressure
  Acupressure is a method based on the correction of yang and yin imbalances in the body by manipulating points located on meridians close to the skin. The primary goal of acupressure is to restore the flow of Qi (Chi/Chi/Chi), the energy that constantly flows throughout the body. From a practical perspective, acupressure requires no special equipment and is non-invasive compared to other treatment techniques.
• Другое placebo acupressure
  Individuals in the placebo (sham) acupressure group will receive placebo (sham) acupressure distant from the designated acupoint.

Первичные конечные точки

• DIABETIC NEUROPATHY SYMPTOM SCORE [Срок оценки: 0-4 weeks]
• Neuropathic Pain Scale [Срок оценки: 0-4 weeks]

Вторичные конечные точки (2)

• BALANCE CONFIDENCE SCALE [Срок оценки: 0-4 weeks]
• European General Quality of Life Scale (EQ-5D). [Срок оценки: 0-4 weeks]

Критерии участия

Критерии включения

Elderly individuals aged 65 years and older

No sensory impairment that would hinder communication

Cognitively capable of answering questions

Able to walk independently or with an assistive device

Have not previously received acupressure therapy for DPN

Diagnosed with diabetic peripheral neuropathy (DPN) by a physician

No orthopedic problems

Provide informed consent

Критерии исключения

Not providing informed consent

History of non-diabetic neuropathy

Physician-diagnosed advanced cardiovascular, kidney, or liver disease

Bleeding tendency

Cerebrovascular disease

History of medical conditions such as retinopathy or nephropathy

Presence of open wounds, ulcers, or orthopedic problems on the feet

Inability to walk independently

Not voluntarily agreeing to participate in the study

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

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07392619 · Nigde Omer Halisdemir Univ.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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