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

NCT07392619 | Not Yet Recruiting DMC

• 1 other identifier: Nigde Omer Halisdemir Univ.
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acupressure; Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

diabetic neuropathic symptoms; balance confidence; fear of falling; quality of life; olderly individuals; acupressure

Outcome Measures

Primary Outcomes (2)

• DIABETIC NEUROPATHY SYMPTOM SCORE

  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

  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 Outcomes (2)

• BALANCE CONFIDENCE SCALE

  0-4 weeks

• European General Quality of Life Scale (EQ-5D).

  0-4 weeks

Study Arms (2)

Acupressure

ACTIVE COMPARATOR

The acupressure group will receive a total of 10 sessions of acupressure over one month.

Other: acupressure

placebo control

PLACEBO COMPARATOR

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

Interventions

acupressure OTHER

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.

Also known as: placebo acupressure

Acupressure

placebo acupressure OTHER

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

placebo control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sultan TAŞCI, Prof. Dr.

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Tugba Aydemir, Phd

CONTACT

+903882112835; tugbaozhan50@gmail.com

Şerife ÇETİN, Phd

CONTACT

srfcngz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.The study will employ a double-blind design. Participants will be randomly assigned to either the acupressure or placebo acupressure groups upon volunteering, with an equal chance of being assigned to either group. A standardized administration procedure/protocol will be used to prevent differences in administration between groups.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: February 6, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): September 5, 2027
• Study Completion (Estimated): September 5, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share