- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07571772
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Yakutiye
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Erzurum, Yakutiye, 터키 (Türkiye)
- Ercan Bakır
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
|
실험적: 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.
다른 이름들:
|
|
간섭 없음: 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.
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|
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가짜 비교기: 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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analog Scale (VAS) - Pain
기간: Baseline and day 7
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10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants mark their current pain intensity.
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Baseline and day 7
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WOMAC Osteoarthritis Index
기간: Baseline and day 7
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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.
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Baseline and day 7
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analog Scale (VAS) - Satisfaction
기간: Baseline and day 7
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10 cm horizontal line ranging from 0 (not satisfied at all) to 10 (completely satisfied).
Participants rate their satisfaction with the treatment.
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Baseline and day 7
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Ercan Bakır, PhD, erzurum tecnical university
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ercanzencefil
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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