Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis: a Randomized Placebo-controlled Trial

In this study, the effects of 4-week aromatherapy massage on pain, functionality, sleep quality and menopausal symptoms will be examined in individuals diagnosed with knee osteoarthritis during menopause.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Bergamot; Other: Placebo

Detailed Description

The aim of this study is to investigate the effect of aromatherapy massage performed with bergamot oil for 4 weeks on pain, function, sleep and menopausal symptoms in menopausal women with knee osteoarthritis. Participants will be randomly divided into 3 groups as Bergamot, placebo and control. In addition to the conventional treatment, the Bergamot group will receive 2 sessions of Bergamot oil per week for 4 weeks, and the placebo group will be massaged with 2 sessions of sweet almond oil for 4 weeks. the control group will continue conventional treatment for 4 weeks. All assessments will be performed before starting treatment and at the end of 4 weeks of treatment. Participants' pain will be evaluated by VAS, Functions by WOMAC, Sleep quality by PSQI, menopausal symptoms by Menopause Symptoms Evaluation scale. At the end of the study, the satisfaction of the participants will be evaluated with VAS.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey
      • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being between the ages of 40-65,
• having entered the menopause,
• being diagnosed with knee OA,
• being at the level of OA 2-3,
• having pain at rest in the knee VAS ≥ 4.

Exclusion Criteria:

• Any knee surgery
• known allergies to the oils to be used

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bergamot; In addition to 4 weeks of conventional treatment, Bergamot oil diluted with 1.5% sweet almond oil (4 drops of aromatic oil to 10 cc of sweet almond oil) will be used on the participants. After the oil is diluted, it will be heated up to 36oC. The participant will sit on the stretcher directly opposite the therapist, with the affected knee semi-flexed. The therapist will massage the affected knee for 15 minutes. After the massage, the knees will be wrapped with a towel for 5 minutes.	Other: Bergamot; The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.
Placebo Comparator: Placebo; In addition to 4 weeks of conventional treatment, Pure sweet almond oil will be used for the participants. Sweet almond oil will be heated to 36oC. The participant will sit on the stretcher directly opposite the therapist, with the affected knee semi-flexed. The therapist will massage the affected knee for 15 minutes. After the massage, the knees will be wrapped with a towel for 5 minutes.	Other: Placebo; The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.
No Intervention: Control; 4 weeks of conventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pain at 4 weeks	The rest, activity and night pains of the participants will be evaluated with a 10 cm Visuak Analog Scale before the treatment and at the end of the 4-week application. "0" means no pain, "10" means excruciating pain. Results will be recorded in cm.	Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in function at 4 weeks	Participants' functions will be evaluated with Western Ontario and McMaster Universities Osteoarthritis Index. A minimum of "0" points and a maximum of "96" points can be obtained on the scale. High scores indicate high impairment and limitation of functional status and poor quality of daily life. Evaluations will be made before the study and after 4 weeks of practice.	Baseline and 4 weeks
Change from baseline in sleep quality at 4 weeks	The sleep quality of the participants will be evaluated with Pittsburgh Sleep Quality Index . The total score is between 0-21. High scores indicate poor sleep quality. Evaluations will be made before the study and after 4 weeks of practice.	Baseline and 4 weeks
Change from baseline in menopause symphtoms at 4 weeks	Participants' menopausal symptoms will be evaluated with the Menopause Symptoms Evaluation Scale. Higher scores indicate more menopausal symptoms. Evaluations will be made before the study and after 4 weeks of practice.	Baseline and 4 weeks
Patients satisfaction after the interventions	Participants' satisfaction with the treatment over pain and function will be evaluated with Visual Analog Scale. Higher score indicate more satisfaction. Evaluation will take place after 4 weeks of study.	4 weeks

Collaborators and Investigators

• Sponsor: KTO Karatay University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 13, 2023

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: KaratayUH8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No