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The Effect of Hot Compress in Patients With Knee Osteoarthritis

2026年4月30日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

他の名前:
  • 対照群
  • Hot Compress with Ginger Oil Application Group
実験的: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.

他の名前:
  • 対照群
  • Hot Compress with Ginger Oil Application Group
介入なし: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.
偽コンパレータ: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.

他の名前:
  • 対照群
  • Hot Compress with Ginger Oil Application Group

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Visual Analog Scale (VAS) - Pain
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Visual Analog Scale (VAS) - Satisfaction
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Ercan Bakır, PhD、erzurum tecnical university

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年5月15日

一次修了 (実際)

2025年8月15日

研究の完了 (実際)

2025年9月15日

試験登録日

最初に提出

2024年2月13日

QC基準を満たした最初の提出物

2026年4月30日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月6日

QC基準を満たした最後の更新が送信されました

2026年4月30日

最終確認日

2026年4月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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