The Effect of Hot Compress in Patients With Knee Osteoarthritis

The Effect of Topical Hot Compress Applications With Black Seed (Nigella Sativa) and Ginger (Zingiber Officinale) Essential Oil on Pain and Patient Satisfaction in Patients With Knee Osteoarthritis: A Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Osteoarthritis, Knee
• Intervention / Treatment: Other: Hot Compress Application Group with Black Cumin Oil

Detailed Description

Knee oteoarthritis (OA) is one of the most common joint diseases worldwide. The prevalence of OA in people aged 20 and over is 203 per 100,000 per year, with 86.7 million people diagnosed with knee OA. In Turkey, the frequency of OA has reached 15%, and it is twice as common in females as in males.

No treatment currently reverses structural deformities caused by OA. Non-pharmacological treatments such as thermotherapy (heat/cold), Tai Chi, yoga, and acupuncture are recommended. Topical applications of herbal extracts and essential oils have also been studied.

Nigella sativa (black cumin) contains thymoquinone, which reduces joint inflammation and rheumatic pain. Zingiber officinale (ginger) has anti-inflammatory and antioxidant effects. Heat application increases blood flow and reduces stiffness and pain.

This randomized controlled experimental study aims to evaluate the effect of hot compress applied with Nigella sativa and Zingiber officinale essential oils on pain, morning stiffness, physical function, and patient satisfaction in knee OA patients.

The study will be conducted at Van Eğitim ve Araştırma Hastanesi, Physical Therapy Unit. Sample size was calculated using G*Power 3.1.7 (α = 0.05, effect size 0.10, power 95%), resulting in 120 participants (30 per group).

Inclusion criteria: aged ≥18 years, physician-diagnosed knee OA, Kellgren-Lawrence stage 3, VAS pain ≥4, no known allergy to the essential oils, no open wound on knee/foot, no knee surgery, not receiving other alternative treatments during the study, and not pregnant.

Exclusion criteria: unwillingness to participate, development of a wound, operation, bruising, or edema in the knee area during the study.

Participants will be randomly assigned to four groups using www.randomization.org:

1. Ginger oil + hot compress group
2. Black cumin oil + hot compress group
3. Sham group (hot compress only)
4. Control group (routine treatment only, no additional intervention) A patch test will be performed on the inner forearm with 3 drops of essential oil for participants in groups 1 and 2. If no allergic reaction (dyspnea, itching, redness, rash) occurs within 20 minutes, the participant will be included.

A hot compress will be applied using a thermophore at 40-50°C, wrapped in a thin towel, placed on both knees for 30 minutes, and covered with another towel. This will be performed once daily for 7 days.

Data collection tools:

• Patient Information Form (sociodemographic and clinical characteristics)
• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) for pain, stiffness, and physical function
• Visual Analog Scale (VAS) for pain (0-10)
• Visual Analog Scale (VAS) for satisfaction (0-10) Assessments will be conducted at baseline (day 1) and at the end of day 7. Statistical analysis will be performed using IBM SPSS 27.0. Descriptive statistics, ANOVA, Kruskal-Wallis, paired t-test, Wilcoxon, and Friedman tests will be used. Post-hoc tests (Tukey for ANOVA, Dunn for Kruskal-Wallis) will be applied. Significance level will be p < 0.05.

Ethical approval was obtained from Osmaniye Korkut Ata University Scientific Ethics Committee (decision no: 4/12, date: 07.04.2026). Institutional permission from Van Eğitim ve Araştırma Hastanesi will be obtained. Written informed consent will be obtained from all participants.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yakutiye
    • Erzurum, Yakutiye, Turkey (Türkiye)
      • Ercan Bakır

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hot Compress Application Group with Black Cumin Oil; 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; 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.; Other Names: Control Group; Hot Compress with Ginger Oil Application Group
Experimental: Hot Compress with Ginger Oil Application Group; 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; 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.; Other Names: Control Group; Hot Compress with Ginger Oil Application Group
No Intervention: Control Group; 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 Comparator: Sham Group; 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; 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.; Other Names: Control Group; Hot Compress with Ginger Oil Application Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) - Satisfaction	10 cm horizontal line ranging from 0 (not satisfied at all) to 10 (completely satisfied). Participants rate their satisfaction with the treatment.	Baseline and day 7

Collaborators and Investigators

• Sponsor: Ercan Bakır
• Investigators: Study Director: Ercan Bakır, PhD, erzurum tecnical university

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Satisfaction; Nursing; Black Seed Oil; Hot Compress; Ginger Oil
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Osteoarthritis; Osteoarthritis, Knee; Personal Satisfaction; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: ercanzencefil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No