Type 2 DiabetesNCT06951412
The Effect of Foot Reflexology Massage on Neuropathic Pain
A study testing Foot Reflexology Massage in people with Type 2 Diabetes, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
This study is conducted to measure the effect of foot reflexology massage on neuropathic pain in diabetic patients.Is reflexology foot massage applied to type 2 diabetic patients effective on neuropathic pain? Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Foot Reflexology Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 15 Mar 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those diagnosed with type 2 diabetes,
- Being 18 years or older
- Individuals who do not have any fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcer and infection.
- Those who volunteer to participate in the study,
- Those who do not have problems with verbal communication,
- Those who have not been diagnosed with any psychiatric disease.
Show all 10Show fewer
- Those with neuropathic pain of 12 points and above according to the LANS score
- Patients receiving duloxetine drug therapy
- Those who are not pregnant
- Patients without peripheral artery disease, deep vein thrombosis and gonatosis will be included in the study. -
Who cannot join
- Those who did not agree to participate in the study
- Those under 18 years of age
- Individuals with no fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcers and infections.
- Those who have problems with verbal communication
- Those with neuropathic pain below 12 points according to the LANS score
- Patients receiving treatment other than duloxetine drug therapy
Show all 9Show fewer
- Those who are pregnant
- Those with any psychiatric disorder
- Patients with peripheral artery disease, deep vein thrombosis and gonatosis will not be included in the study.-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Gaziantep, 27000
About this study
Official title: The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain
This study is conducted to measure the effect of foot reflexology massage on neuropathic pain in diabetic patients.Is reflexology foot massage applied to type 2 diabetic patients effective on neuropathic pain?
Read the detailed description
Controlling pain in individuals with diabetes; It is important for the individual to relax, increase the quality of life, reduce complications and shorten the duration of hospital stay. For this reason, the importance of neuropathic pain and its treatment is increasing in terms of public health. In this study, the effect of foot reflexology massage applied to women with type 2 diabetes on neuropathic pain was measured.
- Conditions
- Type 2 Diabetes
- Being tested
- Foot Reflexology Massage
- Keywords
- Foot massage, Reflexology, Neuropatic pain, Nursing, neuropathy
- 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.
Foot Reflexology MassageOther
Also called complementary therapy
Reflexology Massage
| Study group | Role | What they receive |
|---|---|---|
| The effect of reflexology massage on the average pain score | Experimental | The effect of reflexology massage on neuropathy-related pain score Receives: Other: Foot Reflexology Massage |
| The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain | Experimental | The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain Receives: Other: Foot Reflexology Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
visual analog scale:VAS: It is a scale scored between 0 and 10 points. A score of 0 indicates that the patient has no pain, and a score of 10 indicates that the patient has unbearable pain. The patient gives a score between 0 and 10 depending on the pain condition.
Measured: 6 Weeks
Secondary outcomes (1)
Four Question Neuropathic Pain Questionnaire
This questionnaire consists of a total of 10 items; 7 items are related to the quality of pain (burning, painful cold, electric shocks) and its relationship with abnormal sensations (tingling, pins and needles, numbness, itching), and 3 items are related to the clinical examination of the painful area (touch hypoesthesia, pricking hypoesthesia, tactile allodynia). Each item is scored 1 if the answer is yes and zero if no, with a minimum of zero and a maximum of 10 points. In this assessment, a score of ≥4 out of 10 is considered neuropathic pain
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Model description
- At this stage, the patients in the intervention group received a foot reflexology massage by the researcher in the podiatry room of the Endocrinology and Metabolic Diseases polyclinic in a quiet and calm environment for 6 weeks, two sessions per week, for a total of 12 sessions and 30-40 minutes (15-20 minutes for each foot). Data collection forms were filled out for the patients in the control group, but no application was made.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adile Nese, University of Gaziantep
- Investigators
- Ersin Akarsu, Study director, Gaziantep University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951412
- Sponsor's protocol ID
- Foot Reflexology
- Status last verified
- Apr 2025
- First submitted
- 22 Jun 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paju, W., Yusuf, R., Nurhidayah, J., Fauzi, A., Bata, V. A., & Agustine, U. (2022). The effect of foot massage on peripheral neuropathy in patients with diabetic mellitus: a systematic review. Malaysian Journal of Medicine and Health Sciences, 18(17), 354-362.
de Fátima Megda, L., Terra, A. M. S. V., de Matos, J. B., de Melo Taveira, L., Martínez, B. B., de Cássia Pereira, R., ... & Santos, A. T. S. (2020). Immediate effect of foot reflexology in patients with diabetic neuropathy-Randomized Clinical Trial. Revista Neurociências, 28, 1-22.
Ibrahim MM, Rizk SMA, The efficacy of foot reflexology on the reduction of peripheral diabetic neuropathic pain. J Nurs Health Sci. 2018; 7(5): 44-55.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain
- ClinicalTrials.gov ID
- NCT06951412
- Acronym / sponsor ID
- Foot Reflexology
- Conditions
- Type 2 Diabetes
- Keywords
- Foot massage, Reflexology, Neuropatic pain, Nursing, neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 30 Apr 2025 (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 study is conducted to measure the effect of foot reflexology massage on neuropathic pain in diabetic patients.Is reflexology foot massage applied to type 2 diabetic patients effective on neuropathic pain?
Detailed description
Controlling pain in individuals with diabetes; It is important for the individual to relax, increase the quality of life, reduce complications and shorten the duration of hospital stay. For this reason, the importance of neuropathic pain and its treatment is increasing in terms of public health. In this study, the effect of foot reflexology massage applied to women with type 2 diabetes on neuropathic pain was measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At this stage, the patients in the intervention group received a foot reflexology massage by the researcher in the podiatry room of the Endocrinology and Metabolic Diseases polyclinic in a quiet and calm environment for 6 weeks, two sessions per week, for a total of 12 sessions and 30-40 minutes (15-20 minutes for each foot). Data collection forms were filled out for the patients in the control group, but no application was made.
| Arm | Type | Receives |
|---|---|---|
| The effect of reflexology massage on the average pain score | Experimental | Other: Foot Reflexology MassageThe effect of reflexology massage on neuropathy-related pain score |
| The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain | Experimental | Other: Foot Reflexology MassageThe Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Those diagnosed with type 2 diabetes,
- Being 18 years or older
- Individuals who do not have any fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcer and infection.
- Those who volunteer to participate in the study,
- Those who do not have problems with verbal communication,
Key exclusion criteria (9 listed)
- Those who did not agree to participate in the study
- Those under 18 years of age
- Individuals with no fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcers and infections.
- Those who have problems with verbal communication
- Those with neuropathic pain below 12 points according to the LANS score
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 |
|---|---|---|
| Foot Reflexology MassageAlso: complementary therapyReflexology Massage | Other | The Effect of Foot Reflexology Massage Applied to Women With Type 2 Diabetes on Neuropathic Pain, The effect of reflexology massage on the average pain score |
Primary outcome
pain score
Time frame: 6 Weeks
visual analog scale:VAS: It is a scale scored between 0 and 10 points. A score of 0 indicates that the patient has no pain, and a score of 10 indicates that the patient has unbearable pain. The patient gives a score between 0 and 10 depending on the pain condition.
1 secondary outcome
Four Question Neuropathic Pain Questionnaire
Time frame: 6 weeks
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 30 Apr 2025.
- BackgroundPaju, W., Yusuf, R., Nurhidayah, J., Fauzi, A., Bata, V. A., & Agustine, U. (2022). The effect of foot massage on peripheral neuropathy in patients with diabetic mellitus: a systematic review. Malaysian Journal of Medicine and Health Sciences, 18(17), 354-362.
- Backgroundde Fátima Megda, L., Terra, A. M. S. V., de Matos, J. B., de Melo Taveira, L., Martínez, B. B., de Cássia Pereira, R., ... & Santos, A. T. S. (2020). Immediate effect of foot reflexology in patients with diabetic neuropathy-Randomized Clinical Trial. Revista Neurociências, 28, 1-22.
- BackgroundIbrahim MM, Rizk SMA, The efficacy of foot reflexology on the reduction of peripheral diabetic neuropathic pain. J Nurs Health Sci. 2018; 7(5): 44-55.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Ersin Akarsu study director
Gaziantep University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Reflexology Massage in people with Type 2 Diabetes, run by University of Gaziantep 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 9 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 30 Apr 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?
pain score (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951412, which also lists 3 linked publications.
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 30 Apr 2025.