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Completed

NCT Number: NCT07571772

The Effect of Hot Compress in Patients With Knee Osteoarthritis

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ercan Bakır

Erzurum, Yakutiye, Turkey (Türkiye)

About this study

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:

  • Ginger oil + hot compress group
  • Black cumin oil + hot compress group
  • Sham group (hot compress only)
  • 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Hot Compress with Ginger Oil Application Group, Control Group

Primary outcomes

  1. Visual Analog Scale (VAS) - Pain

    Time frame: Baseline and day 7

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

  2. WOMAC Osteoarthritis Index

    Time frame: Baseline and day 7

    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.

Secondary outcomes

  1. Visual Analog Scale (VAS) - Satisfaction

    Time frame: Baseline and day 7

    10 cm horizontal line ranging from 0 (not satisfied at all) to 10 (completely satisfied). Participants rate their satisfaction with the treatment.

Sponsors and collaborators

Lead sponsor

Ercan Bakır

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2026
Registry last updated
May 6, 2026

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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