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Not yet recruiting NCT07392619

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

No phase Interventional Painful Diabetic Peripheral Neuropathy (PDPN) Acupressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: acupressure, placebo acupressure.
Who it may be relevant to
Registry conditions: Painful Diabetic Peripheral Neuropathy (PDPN), Acupressure. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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:

Overview

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.

Detailed description

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.

Interventions

  • Other 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.
  • Other placebo acupressure
    Individuals in the placebo (sham) acupressure group will receive placebo (sham) acupressure distant from the designated acupoint.

Primary outcome measures

  • DIABETIC NEUROPATHY SYMPTOM SCORE [Time frame: 0-4 weeks]
  • Neuropathic Pain Scale [Time frame: 0-4 weeks]
Secondary outcome measures (2)
  • BALANCE CONFIDENCE SCALE [Time frame: 0-4 weeks]
  • European General Quality of Life Scale (EQ-5D). [Time frame: 0-4 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07392619 · Nigde Omer Halisdemir Univ.

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗