Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

NCT05823077 | Completed

• 1 other identifier: KaratayUH8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in function at 4 weeks

  Baseline and 4 weeks

• Change from baseline in sleep quality at 4 weeks

  Baseline and 4 weeks

• Change from baseline in menopause symphtoms at 4 weeks

  Baseline and 4 weeks

• Patients satisfaction after the interventions

  4 weeks

Study Arms (3)

Bergamot

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Control

NO INTERVENTION

4 weeks of conventional treatment.

Interventions

Bergamot OTHER

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

Bergamot

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

bergamot oil

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: April 21, 2023
• Study Start: May 24, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 13, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-04

Locations

TU (1)