The Effect of Peppermint Oil Aromatherapy on Pain, Functional Capacity and Cost in Fibromyalgia Patients

Bilecik Seyh Edebali Universitesi

Status: Not yet enrolling

Conditions: Fibromyalgia; Aromatherapy; Cost

Treatments: Other: Peppermint Oil; Other: Duloxetine; Other: sweet almond oil

Study type: Interventional

Funder types: Other

Identifiers

NCT07326163

Fibromyalgia

Details and patient eligibility

About

This study was designed to evaluate the effect of topically applied peppermint oil (Mentha × piperita) on chronic pain and functional capacity experienced by fibromyalgia patients, as well as its cost-effectiveness.

Full description

Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, hyperalgesia, and allodynia, often associated with other symptoms such as fatigue, poor sleep quality, anxiety, and depression. The main symptoms of fibromyalgia include widespread body pain, tender points, muscle stiffness, and joint stiffness, but it is also accompanied by insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, and difficulty in maintaining daily activities. Fibromyalgia is the third most common musculoskeletal disorder in terms of prevalence after low back pain and osteoarthritis, with prevalence rates ranging from 1.3% to 8.8% depending on the country. Pain can occur at 18 different points on the head, neck, trunk, and extremities, and can increase throughout the day. The presence of chronic and widespread pain leads to fatigue, sleep disorders, depression, anxiety, helplessness, and mental stress, reducing the quality of life for patients. Additionally, these widespread complaints complicate treatment and increase healthcare costs for patients seeking medical help for fibromyalgia. It is estimated that the total healthcare costs for fibromyalgia patients are three times higher than for other individuals. Both pharmacological and non-pharmacological methods are used in the treatment of fibromyalgia, and aromatherapy is among these methods. Considering the analgesic effects and safe usage profile of peppermint oil, its effectiveness in pain management for fibromyalgia patients is being evaluated. This study aims to assess the impact of topically applied peppermint oil on chronic pain and functional capacity experienced by fibromyalgia patients, as well as its cost-effectiveness.

Enrollment: 175 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria for the study:

• Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria,
• Experiencing chronic pain,
• Volunteers to participate in the study,
• Aged 18 years or older,

Exclusion criteria for the study:

• Those with painful medical conditions other than fibromyalgia (e.g., migraine, diabetic neuropathy, etc.),
• Those with a chronic respiratory system disease (history of asthma or another reactive airway disease),
• Individuals with compromised skin integrity in the application areas,
• Pregnant and/or breastfeeding women,
• Individuals with neurocognitive impairment who are unable to answer the questionnaire,
• Individuals with a known history of allergies,
• Individuals using any topical products during the application period,
• Individuals receiving other complementary treatments for chronic pain management.

Criteria for discontinuing the study:

• Patients who continue their treatment at a different centre after being included in the study,
• Patients who undergo any medication or treatment changes during the study period,
• Patients who are bothered by the scent of the essential oils used (peppermint oil (Mentha × piperita) and sweet almond oil (Prunus amygdalus var. dulcis), or who develop an allergic reaction to essential oils.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

175 participants in 3 patient groups

peppermint oil

Experimental group

Description:

This group of patients will be introduced to the tender points where chronic pain is detected in fibromyalgia patients, and the areas where these tender points are located will be divided into six regions, which will be identified with the patient. Subsequently, one drop of peppermint oil will be applied transdermally to the inner surface of the patient's forearm, and the application site will be monitored for allergic reactions such as redness or swelling. Patients who do not report any allergic reactions will apply 2 drops of peppermint oil to each area transdermally with their fingertip at 8:00 a.m. and 8:00 p.m. This application will be performed twice daily by the patient for 2 weeks. For areas inaccessible to the patient, a relative/caregiver will apply 2 drops of peppermint oil. The first dose will be administered by the researcher, who will demonstrate the application to the patient. The patient's opinions will be sought and questions answered during the first dose application

Treatment:

Other: Peppermint Oil

sweet almond oil

Active Comparator group

Description:

Patients in this group will be introduced to the six sensitive areas where pain is felt, and the locations will be identified with the patient. The patient will apply 2 drops of sweet almond oil to each sensitive area twice daily, at 8:00 a.m. and 8:00 p.m., using their fingertip. This application will be performed twice daily by the patient for 2 weeks. For sensitive areas that the patient cannot access, a family member/caregiver will apply 2 drops of sweet almond oil. The first dose will be administered by the researcher, who will demonstrate the application to the patient. The patient's opinions will be sought and their questions answered during the first dose administration. Sweet almond oil will be provided to patients in dark-coloured glass bottles with droppers and secure caps that open with firm pressure. Patients will be advised to store sweet almond oil at room temperature.

Treatment:

Other: sweet almond oil

Duloxetine

Other group

Description:

Patients in this group will receive treatment planned by a rheumatologist. The pharmacological treatment plan will involve administering duloxetine 60 mg once daily for two weeks, a serotonin-noradrenaline reuptake inhibitor effective on descending pain inhibition pathways in fibromyalgia.

Treatment:

Other: Duloxetine