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NCT Number: NCT05823077

Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bergamot

Other

The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.

Placebo

Other

The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.

Primary outcomes

  1. Change from baseline in pain at 4 weeks

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change from baseline in function at 4 weeks

    Time frame: Baseline and 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.

  2. Change from baseline in sleep quality at 4 weeks

    Time frame: Baseline and 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.

  3. Change from baseline in menopause symphtoms at 4 weeks

    Time frame: Baseline and 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.

  4. Patients satisfaction after the interventions

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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