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

February 4, 2026 updated by: Nigde Omer Halisdemir University

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:

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupressure
The acupressure group will receive a total of 10 sessions of acupressure over one month.
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 Names:
  • placebo acupressure
Placebo Comparator: placebo control
For individuals in the placebo (sham) acupressure group, placebo (sham) acupressure will be applied away from the designated acupoint. The number, duration, frequency and application protocol of sessions in the placebo acupressure group will be the same as in the acupressure group.
Other: placebo acupressure
Individuals in the placebo (sham) acupressure group will receive placebo (sham) acupressure distant from the designated acupoint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DIABETIC NEUROPATHY SYMPTOM SCORE
Time Frame: 0-4 weeks
Diabetic neuropathy symptoms will be assessed using the Diabetic Neuropathy Symptom Score (DNS) and reported as a total score (points).The Diabetic Neuropathy Symptom Score will be used to assess participants' diabetic neuropathy symptoms. It consists of four questions related to gait imbalance, neuropathic pain, paresthesia, and numbness. Each question is scored from 0 (none) to 1 (yes), and a total score is calculated. The maximum score is 4 points, and a score of 1 or higher is defined as positive for DPN.
0-4 weeks
Neuropathic Pain Scale
Time Frame: 0-4 weeks
Neuropathic pain level will be measured using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) questionnaire and reported as a score (points). In this study, the Self-Administered-Leeds Assessment of Neuropathic Symptoms and Signs Pain Score (S-LANSS) will be used to evaluate neuropathic pain. Participants will respond "yes" if the pain symptom is consistent with the description, and "no" if the pain symptom is inconsistent. The total score is scored between 0 and 24. The cutoff value is 12, and if the total score is ≥12, neuropathic mechanisms may be responsible for the pain experienced by the patient.
0-4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BALANCE CONFIDENCE SCALE
Time Frame: 0-4 weeks
Balance confidence in elderly participants will be evaluated using the Activities-specific Balance Confidence (ABC) Scale and reported as a total score (points).One of the tools frequently used to assess fear of falling is the 16-item Activity-Specific Balance Confidence Scale. It is rated from 0 (unsafe) to 100 (completely confident), with a score ranging from 0 to 1600. The total score is divided by 16 to determine the scale score. Higher scores indicate increased balance confidence. A score of <50 out of 100 indicates low physical function, 50-80 indicates moderate physical function, and 80 or above indicates high physical function.
0-4 weeks
European General Quality of Life Scale (EQ-5D).
Time Frame: 0-4 weeks
Quality of life will be measured using the EuroQol 5-Dimension (EQ-5D) questionnaire and reported as a total score (points).Individuals' quality of life will be assessed using the European General Quality of Life Scale (EQ-5D). This is a reporting tool that uses six questions to assess individuals' overall quality of life, independent of their current medical condition. The scale has five dimensions, and each dimension has five levels. The EQ-5D descriptive system measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels corresponding to "no problem", "mild problem", "moderate problem", "severe problem", and "extreme problem". In the EQ-VAS, quality of life scores range from 0 to 100, with 0 representing the worst health condition and 100 representing the best health condition. As the scale score increases, the perception of health increases positively.
0-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Study Director: Sultan TAŞCI, Prof. Dr., TC Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2026

Primary Completion (Estimated)

September 5, 2027

Study Completion (Estimated)

September 5, 2028

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nigde Omer Halisdemir Univ.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect personal data, individual participant data will not be shared. However, study results will be published as an article based on the individuals' voluntary consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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