The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes

December 7, 2025 updated by: Özlem Ceyhan, TC Erciyes University

The aim of this clinical trial is to learn about the effect of aromatherapy foot massage on neuropathic pain in patients with Type 2 diabetes. In addition, while determining the effect of aromatherapy foot massage on neuropathic pain; it was also aimed to find the source of the reduction in pain.

The main questions he aimed to answer are as follows:

Does aromatherapy foot massage have an effect on neuropathic pain in patients with type 2 diabetes? Does foot massage have an effect on neuropathic pain in patients with type 2 diabetes? The researchers will compare an oil without aromatherapy oil with a placebo group to see if aromatherapy foot massage reduces neuropathic pain.

Participants:

Participants will perform the massage treatment three times a week for 4 weeks. Participants will perform foot massage for 10 minutes, 5 minutes on each foot. Participants will be evaluated by calling once a week for 4 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Up to half of diabetic patients suffer from a complication known as diabetic neuropathy, which affects both the autonomic and peripheral nervous systems, with particular damage to the lower extremities. Diabetic neuropathy affects the peripheral sensory nerve endings of the hands and lower extremities, causing pain, numbness, burning and tingling sensations. Symptoms such as pain and burning experienced by diabetics cause a decrease in quality of life. In addition, the risk of ulceration in the feet is more than 15% and the risk of amputation is 15 times higher than non-diabetic individuals. Although diabetic neuropathy is one of the most serious complications of diabetes, its treatment is symptomatic.

In the presence of pain, complementary and integrative therapies such as opioid and non-opioid drugs, surgical methods, manual therapies and various mind-body practices are applied. Massage, one of these methods, is performed by manipulation of the soft tissues of the body. However, massage has the advantages of being applicable to almost every part of the body, not requiring any special equipment and not causing any serious complications. Another method, aromatherapy, uses natural plant extracts known as essential oils to improve physical, mental and emotional health. These essential oils are extracted from various parts of plants, including flowers, leaves, stems, roots and fruits. Aromatherapy oils can be inhaled as inhalers or applied to the skin through massage, baths or compresses. Physiological and pathophysiological benefits of aromatherapy oils on the nervous system have also been supported by studies.

Diabetic neuropathic pain has been associated with mental comorbidity, sleep disorders, more diabetes complications and lower quality of life. Therefore, it is essential to effectively manage pain in diabetic neuropathy and improve the quality of life of the individual. In a study examining the effects of aromatherapy massage on neuropathic pain severity and quality of life; it was found that neuropathic pain scores and quality of life scores improved significantly in the intervention group compared to the control group. In this study, it was not specified whether the reduction in neuropathic pain was the result of massage therapy or a specific essential oil in the aromatherapy mixture, since no intervention was performed in the control group. In our study; while determining the effect of aromatherapy foot massage on neuropathic pain; it was aimed to find the source of the reduction in pain.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Nevşehir Province
      • Nevşehir, Nevşehir Province, Turkey (Türkiye), 50100
        • Nevsehir State Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fatma Buruntekin, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a Douleur neuropathic pain questionnaire score of 4 and above,
  • 18 years and over,
  • No psychiatric illness,
  • Patients who are able to answer all the questions,
  • Turkish-speaking patients.

Exclusion Criteria:

  • Patients who cannot be contacted,
  • Any limb, vascular problem or wound that prevents the application of foot massage,
  • Thrombophlebitis, occlusive arterial disease, fever, etc. Those who are inconvenient to massage due to illness,
  • Patients who refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aromatherapy foot massage

'Patient Introduction Form', "DN4 neuropathic pain questionnaire", "Mcgill pain questionnaire short form" and "Pain-Activity Patterns scale" will be applied through face-to-face interview and the first aromatherapy foot massage will be applied when the patients in the intervention I group first arrive. Patients will be asked to massage the right foot for five minutes and the left foot for five minutes for a total of ten minutes before going to bed three days a week (Monday-Wednesday-Friday) in accordance with the foot massage application protocol.

The 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied again by telephone or face-to-face interview.
Other: intervention I group
'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be applied through face-to-face interview and the first aromatherapy foot massage will be applied when the patients in the intervention I group first arrive. Patients will be asked to massage their right foot for five minutes and their left foot for five minutes before going to bed three days a week (Monday-Wednesday-Friday) for a total of ten minutes in accordance with the foot massage application protocol. 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be administered again by telephone or face-to-face interview.
Other Names:
  • intervention II group
Experimental: foot massage

When the patients in the Intervention II group first arrive, the 'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied through face-to-face interview and the first foot massage with sesame oil will be applied. Patients will be asked to massage the right foot for five minutes and the left foot for five minutes for a total of ten minutes before going to bed three days a week (Monday-Wednesday-Friday) in accordance with the foot massage application protocol.

The 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied again by telephone or face-to-face interview.
Other: Intervention II group
When the patients in the Intervention II group first arrive, the 'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be applied through face-to-face interview and the first foot massage with sesame oil will be applied. Patients will be asked to massage their right foot for five minutes and their left foot for five minutes before going to bed three days a week (Monday-Wednesday-Friday) for a total of ten minutes in accordance with the foot massage application protocol. 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be administered again by telephone or face-to-face interview.
Other Names:
  • intervention II
No Intervention: Control Group

No application will be made to the control group, 'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be collected by face-to-face interview.

'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied again by telephone or face-to-face interview.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
McGILL PAIN SURVEY SHORT FORM (SF-MPQ)
Time Frame: 4 weeks
The scale, which was first developed by Melzack (1987) and validated in Turkish by Yakut et al. (2006), includes 15 descriptive word groups including the characteristics of pain. Eleven of them evaluate the sensory dimension of pain and four of them evaluate the perceptual dimension of pain. These descriptive words are graded on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). In the first part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. Sensory pain score is between 0-33, perceptual pain score is between 0-12 and total pain score is between 0-45. An increase in the score indicates an increase in pain.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DOULEUR NEUROPATHIC PAIN QUESTIONNAIRE (DN4)
Time Frame: The scale will be applied at the first match and at the end of the 4th week.
The scale, which was developed by a French expert group (2005) and validated by Ünal Çevik et al. (2010) in Turkish, consists of 10 items. The first 7 items are related to pain characteristics and sensations and the remaining 3 items are related to examination. A score of '1' is given if the answer is 'yes' and '0' if the answer is 'no'. If the sum of all 10 items is calculated as 4 or more, the patient is defined as having neuropathic pain.
The scale will be applied at the first match and at the end of the 4th week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAIN-ACTIVITY PATTERNS SCALE (POAM-P/ AAPÖ)
Time Frame: The scale will be applied at the first match and at the end of the 4th week.
The scale, which was first developed by Cane et al. (2013) and the Turkish validity and reliability of which was performed by Emine Tunç Süygün (2019), consists of 3 subgroups, namely avoidance, overdoing, and regularisation, and a total of 30 questions, 10 for each subgroup. In the scale, 'Individuals with chronic pain use different ways to do their daily activities. Think about how you usually do your daily activities. For each of the following statements, circle the numbers between 0 and 4 that best describe how you usually do your daily activities'. In answering the scale, a 5-point Likert scoring system is used, 0-never 2-sometimes 4-always. For the sub-groups of avoidance, overdoing and regularisation, the answers given to the questions belonging to the groups are summed separately and the participant's 3 separate sub-group scores are obtained. The total scores calculated for the subgroups vary between 0-40 points separately.
The scale will be applied at the first match and at the end of the 4th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Director: Özlem Ceyhan, Associate Professor, TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

December 9, 2025

Last Update Submitted That Met QC Criteria

December 7, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • aromatherapy foot massage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

individual patient data will only be used within the scope of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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