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The Effect of Hot Compress in Patients With Knee Osteoarthritis

30 aprile 2026 aggiornato da: Ercan Bakır

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

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.

Altri nomi:
  • Gruppo di controllo
  • Hot Compress with Ginger Oil Application Group
Sperimentale: 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.

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.

Altri nomi:
  • Gruppo di controllo
  • Hot Compress with Ginger Oil Application Group
Nessun intervento: 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.
Comparatore fittizio: 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.

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.

Altri nomi:
  • Gruppo di controllo
  • Hot Compress with Ginger Oil Application Group

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analog Scale (VAS) - Pain
Lasso di tempo: Baseline and day 7
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
Lasso di tempo: 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.
Baseline and day 7

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Visual Analog Scale (VAS) - Satisfaction
Lasso di tempo: 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.
Baseline and day 7

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Ercan Bakır, PhD, erzurum tecnical university

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 maggio 2025

Completamento primario (Effettivo)

15 agosto 2025

Completamento dello studio (Effettivo)

15 settembre 2025

Date di iscrizione allo studio

Primo inviato

13 febbraio 2024

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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