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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) - Pain
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Hot Compress Application Group with Black Cumin Oil (Other)
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.
干预措施: Hot Compress Application Group with Black Cumin Oil (Other)
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 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.
干预措施: Hot Compress Application Group with Black Cumin Oil (Other)
结局指标
主要结局
Visual Analog Scale (VAS) - Pain
时间窗: Baseline and day 7
10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants mark their current pain intensity.
WOMAC Osteoarthritis Index
时间窗: 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.
次要结局
- Visual Analog Scale (VAS) - Satisfaction(Baseline and day 7)
研究者
Ercan Bakır
PhD
Erzurum Technical University