Diabetes Mellitus, Type 2NCT06436066
Effect of Self-Acupressure on Peripheral Neuropathic Pain and HbA1c
A study testing Self-Acupressure in people with Diabetes Mellitus, Type 2, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Self-Acupressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jul 2024to 22 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Self-Acupressure Application on Peripheral Neuropathic Pain and HbA1c in Patients With Type 2 Diabetes
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.
Read more
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Self-Acupressure
- Keywords
- Self-acupressure, HbA1c, Peripheral Neuropathic Pain
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-AcupressureOther
Applications include the following parameters;
- Patient Information Form (before and after application)
- Neuropathic Pain Questionnaire - DN4 (before and after application)
- Neuropathic Pain Questionnaire - Short Form (before and after application)
- Providing self-acupressure training (before application)
- Delivery of the self-acupressure training booklet (before application)
- Sending weekly reminder messages (during implementation)
- Calling the patient for a check-up after 3 months and re-evaluating with the same scales (After the application)
- Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale (After application)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | A self-acupressure training booklet was created in line with the relevant literature. For the training booklet, expert opinions were received from 5 clinician nurses and 5 academic nurses who are experts in their fields. The training booklet includes the definition of self-acupressure, the areas in which it is used, its benefits, the purpose of the study, the points where acupressure will be applied and the application procedure. After 30 minutes of self-acupressure training was given to the patients in the intervention group, the relevant training booklet was delivered. Reminder messages will be sent to patients every week. They will be asked to do it 3 days a week and for 3 months. They were informed to come for a check-up after 3 months. Receives: Other: Self-Acupressure |
| Control Group | No intervention | Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters; 1. Patient Information Form 2. Neuropathic Pain Questionnaire - DN4 3. Neuropathic Pain Questionnaire - Short Form 4. Providing acupressure training to diabetic patients who wish to do so at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
Measured: First day and 3th months
Neuropathic Pain Questionnaire - DN4
In the survey, neuropathic pain is evaluated with questions based on interview with the individual and clinical examination. The highest score that can be obtained is 10. The cutoff value for neuropathic pain is accepted as 4/10.
Measured: First day and 3th months
Neuropathic Pain Questionnaire - Short Form
Tingling, numbness and pain that increases with touch are evaluated. If the obtained scores are analyzed according to the calculation instructions, the result will reveal whether the pain in the individual is neuropathic or not.
Measured: First day and 3th months
Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale
Visual Analogue Scale (VAS) will be used to evaluate patients' satisfaction with acupressure self-administration. In the scale, a score of "1" indicates that they are not satisfied with self-acupressure, a score of "5" indicates that satisfaction is at a medium level, a score of "10" indicates that satisfaction is very high, and as the score increases, it will be stated that satisfaction increases. Patients will be asked to self-rate their acupressure satisfaction level.
Measured: 3th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start25 Jul 2024
- Primary completion25 Nov 2024
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Selda Çelik, PhD, Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436066
- Sponsor's protocol ID
- EAVSAR
- Status last verified
- May 2025
- First submitted
- 14 May 2024
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Self-Acupressure Application on Peripheral Neuropathic Pain and HbA1c in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06436066
- Acronym / sponsor ID
- EAVSAR
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Self-acupressure, HbA1c, Peripheral Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Self-AcupressureA self-acupressure training booklet was created in line with the relevant literature. For the training booklet, expert opinions were received from 5 clinician nurses and 5 academic nurses who are experts in their fields. The training booklet includes the definition of self-acupressure, the areas in which it is used, its benefits, the purpose of the study, the points where acupressure will be applied and the application procedure. After 30 minutes of self-acupressure training was given to the patients in the intervention group, the relevant training booklet was delivered. Reminder messages will be sent to patients every week. They will be asked to do it 3 days a week and for 3 months. They were informed to come for a check-up after 3 months. |
| Control Group | No intervention | –Routine clinical care continued to be provided to the patients in the control group. Routine maintenance applications include the following parameters; 1. Patient Information Form 2. Neuropathic Pain Questionnaire - DN4 3. Neuropathic Pain Questionnaire - Short Form 4. Providing acupressure training to diabetic patients who wish to do so at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years and over,
- Diagnosed with type-2 diabetes,
- Diagnosed with peripheral neuropathy,
- DN4 score ≥ 4,
- Not diagnosed with a psychiatric disease,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-AcupressureApplications include the following parameters; 1. Patient Information Form (before and after application) 2. Neuropathic Pain Questionnaire - DN4 (before and after application) 3. Neuropathic Pain Questionnaire - Short Form (before and after application) 4. Providing self-acupressure training (before application) 5. Delivery of the self-acupressure training booklet (before application) 6. Sending weekly reminder messages (during implementation) 7. Calling the patient for a check-up after 3 months and re-evaluating with the same scales (After the application) 8. Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale (After application) | Other | Intervention Group |
Primary outcome
Patient Information Form
Time frame: First day and 3th months
The form prepared by the researcher includes questions inquiring about the sociodemographic and background information of the patients, clinical characteristics and laboratory results.
Neuropathic Pain Questionnaire - DN4
Time frame: First day and 3th months
In the survey, neuropathic pain is evaluated with questions based on interview with the individual and clinical examination. The highest score that can be obtained is 10. The cutoff value for neuropathic pain is accepted as 4/10.
Neuropathic Pain Questionnaire - Short Form
Time frame: First day and 3th months
Tingling, numbness and pain that increases with touch are evaluated. If the obtained scores are analyzed according to the calculation instructions, the result will reveal whether the pain in the individual is neuropathic or not.
Self-Acupressure - Satisfaction Evaluation Form with Visual Analogue Scale
Time frame: 3th months
Visual Analogue Scale (VAS) will be used to evaluate patients' satisfaction with acupressure self-administration. In the scale, a score of "1" indicates that they are not satisfied with self-acupressure, a score of "5" indicates that satisfaction is at a medium level, a score of "10" indicates that satisfaction is very high, and as the score increases, it will be stated that satisfaction increases. Patients will be asked to self-rate their acupressure satisfaction level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Çelik, PhD study director
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Acupressure in people with Diabetes Mellitus, Type 2, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: First day and 3th months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.