Clinical trial NCT06436066: Effect of Self-Acupressure on Peripheral Neuropathic Pain and HbA1c
Official title: Effect of Self-Acupressure Application on Peripheral Neuropathic Pain and HbA1c in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Self-acupressure
HbA1c
Peripheral Neuropathic Pain
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study was conducted to examine the effect of self-applied acupressure on HbA1c and peripheral neuropathic pain in patients diagnosed with type 2 diabetes.

Background: Acupressure is an effective method for relieving pain, and this effectiveness is explained by the gate control theory and endorphin theory. There is only one study in the literature showing that acupressure reduces diabetic neuropathic pain. However, in this study, acupressure was performed by a trained health professional, not by the patient himself. Measurement of glycosylated hemoglobin (HbA1c) level is one of the standard methods for long-term management of diabetes and indicates the average blood glucose concentration over a three-month period. As a result of a meta-analysis study conducted in 2023, it was reported that acupressure significantly reduced the HbA1c level.

Design: This study was designed as a randomized controlled and experimental type study.

Methods: The study is conducted with patients with type 2 diabetes who are followed in the diabetes outpatient clinic of a training and research hospital between May-November 2024. There are 2 arms in the study. The study is conducted with a total of 60 patients, 30 in the control group and 30 in the intervention group. Data collection tools are "Patient Information Form", "Neuropathic Pain Questionnaire - DN4", "Neuropathic Pain Questionnaire - Short Form" and "Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale". While patients in the control group continue to receive routine care, patients in the intervention group are given self-acupressure training. Patients who receive training perform acupressure on their own 3 days a week for 3 months and record it on the follow-up form.

Detailed description: Patients with diabetes need to maintain many factors such as appropriate lifestyle changes, nutrition regulation, exercise, regular use of medications and insulin in order to prevent the emergence of peripheral neuropathy and various symptoms that develop accordingly or to control the current problem. Patients with diabetes are increasingly turning to complementary medicine methods to support such a complex process. One of these methods is acupressure, which does not involve any invasive procedures. Acupressure regulates blood flow by providing vasodilation and reduces the release of epinephrine and norepinephrine. Acupressure is a safe technique because it is a non-invasive practice. There is only one study in the literature examining the effect of acupressure on diabetic peripheral neuropathic pain, but the method used in this study is not self-acupressure, but acupressure applied by a healthcare professional. There are also studies showing that acupressure reduces plasma blood glucose levels. Self-acupressure is a method that has no side effects, is simple, convenient, does not require special equipment, and can be applied cost-effectively by trained individuals. Nurses can easily learn acupressure, apply it in clinics to increase patients' comfort and reduce symptoms, and teach patients to apply it on their own. When a person learns how to apply acupressure on his own, he needs less help to complete his treatment.This study, which was conducted to determine whether self-applied acupressure by patients diagnosed with type 2 diabetes has an effect on HbA1c and peripheral neuropathic pain, will add innovation to the literature, will guide new research in this context, and can alleviate diabetic peripheral neuropathic pain thanks to self-acupressure training given to the patient. It is thought that it will provide blood glucose level regulation and sustainability, reduce the frequency of admission to healthcare institutions and be a cost-effective application.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* Diagnosed with type-2 diabetes,
* Diagnosed with peripheral neuropathy,
* DN4 score ≥ 4,
* Not diagnosed with a psychiatric disease,
* No hearing, visual or physical disabilities
* Knowing how to read and write,
* Able to communicate, no language problems,
* Having the equipment (smartphone, computer, tablet, etc.) to watch self-acupressure videos and receive reminder text messages,
* Patients who volunteer to participate in the study and give verbal and written consent will be included in the study.

Exclusion Criteria:

* Presence of lesion/scar/mass/open wound at the point where acupressure will be applied,
* Having a non-diabetic disease that causes neuropathy,
* Starting to use new medication to control neuropathic symptoms,
* Changing the dose of the current drug used to control neuropathic symptoms (if it is used routinely and the dose will not be changed, it can be included in the study),
* Adding a new oral antidiabetic drug to your current treatment,
* Not using insulin normally and starting a new insulin treatment,
* The need for a new insulin dose adjustment in insulin users (individuals who currently use insulin and whose dose will not be changed can be included in the study),
* Failure to comply with planned initiatives,
* Using psychiatric medication,
* Having a visual or hearing impairment,
* Having a mental disability or perception problem,
* Already doing self-acupressure,
* Not being willing to participate in the study is a criterion that will exclude individuals from the study.

Primary outcomes:
measure: Patient Information Form
timeFrame: First day and 3th months
measure: Neuropathic Pain Questionnaire - DN4
timeFrame: First day and 3th months
measure: Neuropathic Pain Questionnaire - Short Form
timeFrame: First day and 3th months
measure: Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale
timeFrame: 3th months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
state: Ataşehir
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Selda Çelik, PhD
role: STUDY_DIRECTOR
References: