An interventional study of acupressure and placebo acupressure in Painful Diabetic Peripheral Neuropathy (PDPN) and Acupressure, sponsored by Nigde Omer Halisdemir University. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Supportive care
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.
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.
Nigde Omer Halisdemir University is the lead sponsor of 93 studies on the registry; 31 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Not providing
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The acupressure group will receive a total of 10 sessions of acupressure over one month.
Other: acupressure
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
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
Individuals in the placebo (sham) acupressure group will receive placebo (sham) acupressure distant from the designated acupoint.
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.
Time frame: 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.
Time frame: 0-4 weeks
BALANCE CONFIDENCE SCALE
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.
Time frame: 0-4 weeks
European General Quality of Life Scale (EQ-5D).
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.
Time frame: 0-4 weeks
No study locations are listed for this record.
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Nigde Omer Halisdemir University