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

Overview

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.

Detailed 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.

Interventions

• Other Peppermint Oil
  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 allergi
• Other sweet almond oil
  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 ad
• Other Duloxetine
  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.

Primary outcome measures

• Visual Analog Scale [Time frame: 2 weeks]
• The short-form McGill Pain Questionnaire [Time frame: 2 weeks]
• The Revised Fibromyalgia Impact Questionnaire (FIQR) [Time frame: 2 weeks]
• Collection of Cost Data from the Perspective of the Reimbursement Agency (Social Security Institution) [Time frame: 2 weeks]
• Collection of Cost Data from the Direct Patient Cost Perspective [Time frame: 2 weeks]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Bilecik Training and Research Hospital — Bilecik

Identifiers

NCT: NCT07326163 · Fibromyalgia

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗