The Effect of Hot Compress in Patients With Knee Osteoarthritis

NCT07571772 | Completed

• 1 other identifier: ercanzencefil
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine the effect of hot compress applied with Nigella sativa (black cumin) and Zingiber officinale (ginger) essential oils on pain, morning stiffness, physical function, and patient satisfaction in individuals with knee osteoarthritis. The study is planned as a randomized controlled experimental study with 120 participants. Inclusion criteria: aged 18 and over, diagnosed with knee OA, Kellgren-Lawrence stage 3, VAS pain score ≥4, no known allergy to the essential oils, no open wound on the knee/foot, no knee surgery, not receiving any other alternative treatment during the study period, and not pregnant. Participants will be randomly assigned to four groups (30 each): 1) ginger oil + hot compress, 2) black cumin oil + hot compress, 3) sham (hot compress only), 4) control (routine treatment only). Data collection tools: Patient Information Form, WOMAC, VAS-pain, VAS-satisfaction. Applications will be performed once daily for 7 days (30 minutes per session). Assessments will be conducted at baseline and on day 7.

Conditions

Osteoarthritis, Knee; Pain

Keywords

Osteoarthritis; Black Seed Oil; Ginger Oil; Hot Compress; Pain; Satisfaction; Nursing

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) - Pain

  10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants mark their current pain intensity.

  Baseline and day 7

• WOMAC Osteoarthritis Index

  Validated 24-item questionnaire assessing pain, stiffness, and physical function in knee osteoarthritis. Each item scored 1-5 (none to extreme). Higher scores indicate worse symptoms.

  Baseline and day 7

Secondary Outcomes (1)

• Visual Analog Scale (VAS) - Satisfaction

  Baseline and day 7

Study Arms (4)

Hot Compress Application Group with Black Cumin Oil

EXPERIMENTAL

Experimental group. Topical application of 15 drops of Nigella sativa (black cumin) essential oil to each knee with gentle massage, followed by hot compress (thermophore at 40-50°C wrapped in a towel) for 30 minutes. Applied once daily for 7 days. Patch test performed before first application to rule out allergy. Assessments at baseline and day 7: WOMAC, VAS-pain, VAS-satisfaction.

Other: Hot Compress Application Group with Black Cumin Oil

Hot Compress with Ginger Oil Application Group

EXPERIMENTAL

Experimental group. Topical application of 15 drops of Zingiber officinale (ginger) essential oil to each knee with gentle massage, followed by hot compress (thermophore at 40-50°C wrapped in a towel) for 30 minutes. Applied once daily for 7 days. Patch test performed before first application to rule out allergy. Assessments at baseline and day 7: WOMAC, VAS-pain, VAS-satisfaction.

Other: Hot Compress Application Group with Black Cumin Oil

Control Group

NO INTERVENTION

Control group. Participants receive routine medical treatment only. No hot compress and no essential oil application will be performed. Data collection (patient information form, Kellgren-Lawrence staging, WOMAC, VAS-pain, VAS-satisfaction) will be done at baseline and on day 7.

Sham Group

SHAM COMPARATOR

Participants in this group receive only hot compress application (thermophore at 40-50°C for 30 minutes once daily for 7 days). No essential oil is applied.

Other: Hot Compress Application Group with Black Cumin Oil

Interventions

Hot Compress Application Group with Black Cumin Oil OTHER

Black Cumin Oil was applied to both knees. This practice continued for 7 days. The final test was administered at the end of the 7th day. Ginger Oil was applied to both strings. This practice continued for 7 days. The final test was administered at the end of the 7th day. No intervention was made to the Control Group. He was provided with routine treatment.

Also known as: Hot Compress with Ginger Oil Application Group, Control Group

Hot Compress Application Group with Black Cumin Oil; Hot Compress with Ginger Oil Application Group; Sham Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Physician-diagnosed knee osteoarthritis according to American College of Rheumatology (ACR) criteria
• Kellgren-Lawrence grade 3 (moderate) osteoarthritis
• Pain score of 4 or higher on Visual Analog Scale (VAS 0-10)
• No known allergy to Nigella sativa (black cumin) or Zingiber officinale (ginger) essential oils
• No open wounds on the knee or foot
• No previous knee surgery
• Not receiving any other alternative treatment (e.g., acupuncture, herbal therapy) during the study period
• Females must not be pregnant

You may not qualify if:

• Age under 18 years
• Kellgren-Lawrence grade 1, 2, or 4
• VAS pain score below 4
• Known allergy to the essential oils used
• Open wound on knee or foot
• Previous knee surgery
• Receiving other alternative treatment during the study period
• Pregnancy or breastfeeding
• Unwillingness to participate or inability to provide informed consent

Sponsors & Collaborators

• Ercan Bakır: lead

Study Sites (1)

Ercan Bakır

Erzurum, Yakutiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis; Personal Satisfaction

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ercan Bakır, PhD

  erzurum tecnical university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: May 6, 2026
• Study Start: May 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: September 15, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)