Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05823077
• Other study ID #: KaratayUH8
• Status: Completed
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: August 13, 2023

Study information

• Verified date: April 2023
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 13, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Bergamot
The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.
• Placebo
The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.

Locations

Country	Name	City	State
Turkey	KTO Karatay University	Konya	Karatay

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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