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

ConditionsPainful Diabetic Peripheral Neuropathy (PDPN)Acupressure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorNigde Omer Halisdemir University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • acupressure

    Other intervention

    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.

  • placebo acupressure

    Other intervention

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: AcupressureActive comparator 1 intervention
Group B: placebo controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nigde Omer Halisdemir University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator

Source ClinicalTrials.gov

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