Diabetes Mellitus, Type 2NCT05647083
The Effect of Massage on Diabetic Parameters
A study testing Massage therapy in people with Diabetes Mellitus, Type 2 and Peripheral Neuropathy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This research aims to investigate the effect of massage on diabetic foot risk, HbA1c and physiological parameters in individuals with type 2 diabetes. This randomized controlled experimental design will be carried out in Bolu Izzet Baysal State Hospital Köroğlu Unit Internal Medicine Polyclinic and Internal Medicine… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Peripheral Neuropathy
- What is being tested?
- Massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2022to 9 Feb 2024
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between 30-75 years old,
- Diagnosed with diabetes at least 6 months ago,
- Absence of irritation, ulceration in the areas where the massage will be applied (hands, feet and legs),
- No problem in verbal communication,
- Being able to speak Turkish,
- No diagnosis of psychiatric disease,
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- Absence of amputation in the upper and lower extremities,
- Having HbA1c test results in the last 1 week,
- Not having had Covid-19 in the last 6 months
- No experience of massage application in the last 1 month
- Willingness to participate in the research
Who cannot join
- Presence of diabetic ulcer and foot wound,
- Irritation and ulceration in the areas where the massage will be applied (hands, feet and legs),
- Having problems in verbal communication,
- Not being able to speak Turkish,
- Having a diagnosis of psychiatric illness.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Provincial Health Directorate Bolu Izzet Baysal State Hospital
Bolu
About this study
Official title: The Effect of Massage on Diabetic Foot Risk, HbA1c and Physiological Parameters in People With Type 2 Diabetes
This research aims to investigate the effect of massage on diabetic foot risk, HbA1c and physiological parameters in individuals with type 2 diabetes. This randomized controlled experimental design will be carried out in Bolu Izzet Baysal State Hospital Köroğlu Unit Internal Medicine Polyclinic and Internal Medicine Service. According to power analysis, the minimum sample size was determined as 60 people, 30 of which were in the intervention group and 30 in the control group. Data collection tools include "Peripheral Neuropathy Sign and Symptom Score", "Ankle-Brachial Index (ABI)", "Glycemic Control Assessment (HbA1c)", "Physiological Parameters (blood pressure, heart rate and oxygen saturation)", "Inlow's 60-second Diabetic Food Screen". A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Participants in the control group will continue their medical treatment protocols and massage will not be applied.
- Conditions
- Diabetes Mellitus, Type 2, Peripheral Neuropathy
- Being tested
- Massage therapy
- Keywords
- massage, glycemic control, diabetic foot risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyOther
Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Sesame oil will be used as the main oil in the massage application. Massage times are recommended as 10-15 minutes for upper extremity massage and 15-20 minutes for lower extremity massage. Receives: Other: Massage therapy |
| Control group | No intervention | Participants in the control group will continue their medical treatment protocols and massage will not be applied. Measurement tools and physiological measurements will be evaluated at the frequency specified in the intervention group, using the same measurement tools and the same measurement methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Means of Peripheral Neuropathy Sign and Symptom Score
Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score;
- Discomfort they feel in their feet,
- Location of complaints,
- The presence of complaints increases at night,
- Time of occurrence of complaints and
- 5 questions will be asked about how the complaints decreased. Peripheral neuropathy symptom score obtained from 5 questions was 0-2 points, "normal"; 3-4 points, "mild neuropathy"; 5-6 points, "moderate neuropathy"; A score of 7-9 will be considered "severe neuropathy".
For peripheral neuropathy finding score; It will be determined based on four parameters including 1. Vibration sense, 2. Pimpiric test, 3. Achille tendon reflex, 4. Protective sensory examination
Measured: Change from baseline Neuropathy score at 3 months
Means of Ankle-Brachial Index Score
It is calculated by dividing the tibialis posterior pressure by the brachial arterial pressure. The highest of the four measurements at the ankles and feet is divided by the two higher brachial measurements. The normal value is close to 1.
Measured: Change from baseline Ankle-Brachial Index score at 3 months
Means of HbA1c (%)
HbA1c values of the participants will be monitored as a glycemic control parameter. The HbA1c value will be evaluated at baseline and 3 months later, as it represents the three-month average blood glucose value. For the measurement of HbA1c, the test results within the last week will be taken from the participants at the beginning and a blood sample will be taken into ethylenediaminetetraacetic acid (EDTA) coated tubes (2 mL whole) by a nurse three months later.
Measured: Change from baseline HbA1c score at 3 months
Means of systolic blood pressure (mmHg)
It will be measured by the researcher with a manual measurement tool.
Measured: Change from baseline systolic blood pressure at 3 months
Means of diastolic blood pressure (mmHg)
It will be measured by the researcher with a manual measurement tool.
Measured: Change from baseline diastolic blood pressure at 3 months
Means of heart rate (/minutes)
It will be measured by the researcher with a pulse oximeter.
Measured: Change from baseline heart rate at 3 months
Means of oxygen saturation (%)
It will be measured by the researcher with a pulse oximeter.
Measured: Change from baseline oxygen saturation at 3 months
Means of diabetic foot risk score
"Inlow's 60-second Diabetic Food Screen" form will be used in diabetes foot risk assessment. Diabetic foot examination consists of 12 parameters. Skin Assessment, Evaluation of Nail Structure, deformity, Evaluation of the Shoe, Heat Evaluation - Being Cold, Heat Evaluation - Being Hot, Range of Motion Evaluation, Sensory Evaluation, Sensory Evaluation (Assessment with questions directed to individuals), Evaluation of Pedal Pulses, Dependent Rubor Evaluation, Evaluation of Erythema (Redness). The minimum score to be taken from the foot examination form is evaluated as 0 and the maximum score as 23 points. The higher the score, the higher the risk of diabetic foot.
Measured: Change from baseline diabetic foot risk score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start9 Sep 2022
- Primary completion9 Feb 2024
- Study completion9 Feb 2024
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.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gencer Sendur, Abant Izzet Baysal University
- Investigators
- Elif Gençer Şendur, MSC, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647083
- Sponsor's protocol ID
- BAIBU-SBF-EGS-2
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage on Diabetic Foot Risk, HbA1c and Physiological Parameters in People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05647083
- Acronym / sponsor ID
- BAIBU-SBF-EGS-2
- Conditions
- Diabetes Mellitus, Type 2, Peripheral Neuropathy
- Keywords
- massage, glycemic control, diabetic foot risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 12 Dec 2022 (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.
This research aims to investigate the effect of massage on diabetic foot risk, HbA1c and physiological parameters in individuals with type 2 diabetes. This randomized controlled experimental design will be carried out in Bolu Izzet Baysal State Hospital Köroğlu Unit Internal Medicine Polyclinic and Internal Medicine Service. According to power analysis, the minimum sample size was determined as 60 people, 30 of which were in the intervention group and 30 in the control group. Data collection tools include "Peripheral Neuropathy Sign and Symptom Score", "Ankle-Brachial Index (ABI)", "Glycemic Control Assessment (HbA1c)", "Physiological Parameters (blood pressure, heart rate and oxygen saturation)", "Inlow's 60-second Diabetic Food Screen". A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Participants in the control group will continue their medical treatment protocols and massage will not be applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Massage therapyA total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Sesame oil will be used as the main oil in the massage application. Massage times are recommended as 10-15 minutes for upper extremity massage and 15-20 minutes for lower extremity massage. |
| Control group | No intervention | –Participants in the control group will continue their medical treatment protocols and massage will not be applied. Measurement tools and physiological measurements will be evaluated at the frequency specified in the intervention group, using the same measurement tools and the same measurement methods. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Being between 30-75 years old,
- Diagnosed with diabetes at least 6 months ago,
- Absence of irritation, ulceration in the areas where the massage will be applied (hands, feet and legs),
- No problem in verbal communication,
- Being able to speak Turkish,
Key exclusion criteria (5 listed)
- Presence of diabetic ulcer and foot wound,
- Irritation and ulceration in the areas where the massage will be applied (hands, feet and legs),
- Having problems in verbal communication,
- Not being able to speak Turkish,
- Having a diagnosis of psychiatric illness.
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 |
|---|---|---|
| Massage therapyClassical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes. | Other | Intervention group |
Primary outcome
Means of Peripheral Neuropathy Sign and Symptom Score
Time frame: Change from baseline Neuropathy score at 3 months
Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score; * Discomfort they feel in their feet, * Location of complaints, * The presence of complaints increases at night, * Time of occurrence of complaints and * 5 questions will be asked about how the complaints decreased. Peripheral neuropathy symptom score obtained from 5 questions was 0-2 points, "normal"; 3-4 points, "mild neuropathy"; 5-6 points, "moderate neuropathy"; A score of 7-9 will be considered "severe neuropathy". For peripheral neuropathy finding score; It will be determined based on four parameters including 1. Vibration sense, 2. Pimpiric test, 3. Achille tendon reflex, 4. Protective sensory examination
Means of Ankle-Brachial Index Score
Time frame: Change from baseline Ankle-Brachial Index score at 3 months
It is calculated by dividing the tibialis posterior pressure by the brachial arterial pressure. The highest of the four measurements at the ankles and feet is divided by the two higher brachial measurements. The normal value is close to 1.
Means of HbA1c (%)
Time frame: Change from baseline HbA1c score at 3 months
HbA1c values of the participants will be monitored as a glycemic control parameter. The HbA1c value will be evaluated at baseline and 3 months later, as it represents the three-month average blood glucose value. For the measurement of HbA1c, the test results within the last week will be taken from the participants at the beginning and a blood sample will be taken into ethylenediaminetetraacetic acid (EDTA) coated tubes (2 mL whole) by a nurse three months later.
Means of systolic blood pressure (mmHg)
Time frame: Change from baseline systolic blood pressure at 3 months
It will be measured by the researcher with a manual measurement tool.
Means of diastolic blood pressure (mmHg)
Time frame: Change from baseline diastolic blood pressure at 3 months
It will be measured by the researcher with a manual measurement tool.
Means of heart rate (/minutes)
Time frame: Change from baseline heart rate at 3 months
It will be measured by the researcher with a pulse oximeter.
Means of oxygen saturation (%)
Time frame: Change from baseline oxygen saturation at 3 months
It will be measured by the researcher with a pulse oximeter.
Means of diabetic foot risk score
Time frame: Change from baseline diabetic foot risk score at 3 months
"Inlow's 60-second Diabetic Food Screen" form will be used in diabetes foot risk assessment. Diabetic foot examination consists of 12 parameters. Skin Assessment, Evaluation of Nail Structure, deformity, Evaluation of the Shoe, Heat Evaluation - Being Cold, Heat Evaluation - Being Hot, Range of Motion Evaluation, Sensory Evaluation, Sensory Evaluation (Assessment with questions directed to individuals), Evaluation of Pedal Pulses, Dependent Rubor Evaluation, Evaluation of Erythema (Redness). The minimum score to be taken from the foot examination form is evaluated as 0 and the maximum score as 23 points. The higher the score, the higher the risk of diabetic foot.
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 19 Apr 2024.
- 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.
Elif Gençer Şendur, MSC principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Diabetes Mellitus, Type 2 and Peripheral Neuropathy, run by Abant Izzet Baysal 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 11 inclusion and 5 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 19 Apr 2024. 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?
Means of Peripheral Neuropathy Sign and Symptom Score (time frame: Change from baseline Neuropathy score at 3 months). The study lists 8 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 19 Apr 2024.