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Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bergamot
Placebo
Sponsored by
KTO Karatay University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • KTO Karatay University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Bergamot

Placebo

Control

Arm Description

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.

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.

4 weeks of conventional treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 8, 2023
Last Updated
August 17, 2023
Sponsor
KTO Karatay University
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1. Study Identification

Unique Protocol Identification Number
NCT05823077
Brief Title
Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis
Official Title
Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis: a Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KTO Karatay University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bergamot
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
4 weeks of conventional treatment.
Intervention Type
Other
Intervention Name(s)
Bergamot
Intervention Description
The affected knee will be massaged with Bergamot oil for 4 weeks, 2 sessions per week.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The affected knee will be massaged with sweet almond oil for 4 weeks, 2 sessions per week.
Primary Outcome Measure Information:
Title
Change from baseline in pain at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in function at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in sleep quality at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change from baseline in menopause symphtoms at 4 weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Patients satisfaction after the interventions
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
KTO Karatay University
City
Konya
State/Province
Karatay
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

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