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临床试验/NCT07318116
NCT07318116Enrolling By Invitation不适用

The Effect of Cabbage Leaf Application on Pain, Physical Function and Quality of Life Levels of Patients With Knee Osteoarthritis

Inonu University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
90
试验地点
1
主要终点
Change in Knee Pain Severity

研究概览

简要总结

Among non-pharmacological treatment methods, herbal therapies are widely used, and cabbage leaves are recognized for their analgesic and anti-edematous effects. Previous studies indicate that patients often use cabbage leaves for breast engorgement and joint pain, and their strong antioxidant, anticancer, and anti-inflammatory properties have been demonstrated. This study aims to examine the effects of cabbage leaf application on pain, physical function, and quality of life in patients with knee osteoarthritis.

This research is designed as an experimental, mixed-method, randomized controlled trial with a pretest-posttest structure. It will be conducted at the Physical Therapy and Rehabilitation outpatient clinic and inpatient units of Şırnak State Hospital between 01.08.2025 and 01.08.2026. A total of 90 patients will be included and randomly assigned to three groups of 30 participants: those receiving room-temperature cabbage leaf application (Experimental Group 1), those receiving traditionally prepared cabbage leaf application (Experimental Group 2), and those receiving no cabbage leaf application (Control Group).

Data will be collected using the Patient Information Form, A-VAS, WOMAC, and the Mini-OAKHQoL-TR Scale. Experimental groups will receive a daily 2-hour cabbage leaf application for 4 weeks, while the control group will receive routine care only. Measurements will be conducted at weeks 1 and 4.

Data will be analyzed using SPSS 22.0. Descriptive statistics will summarize the sample. Normality will be tested with the Kolmogorov-Smirnov test. For normally distributed data, independent t-test, paired t-test, ANOVA, and ANCOVA will be used; for non-normal data, Mann-Whitney U, Kruskal-Wallis H, Wilcoxon signed-rank, and Friedman tests will be applied.

This study aims to contribute evidence supporting non-pharmacological interventions as alternative or complementary approaches in managing joint and knee pain. Such applications may help reduce healthcare costs, decrease hospitalization rates, improve accessibility, save time, and provide an economical therapeutic option within clinical practice.

详细描述

Osteoarthritis, which develops under the influence of genetic, mechanical, or biochemical factors, is a chronic inflammatory degenerative joint disease characterized by morphological alterations of the synovial membrane and joint capsule, including synovial inflammation, progressive cartilage degradation, the formation of osteophytes, and subchondral bone sclerosis, particularly in weight-bearing joints. Due to the greater degree of degeneration in weight-bearing joints, the knee is the most commonly affected joint in symptomatic osteoarthritis. In addition to the knee, the hip, spine, hand, foot, and fingers are among the other joints frequently involved. Progressive cartilage loss in the knee joint leads to limitations in range of motion, severe chronic pain, and significant muscle atrophy. Knee pain-often sharp, dull, continuous, or intermittent-is one of the most common symptoms associated with osteoarthritis. Crepitus during physical examination, stiffness and swelling, restricted motion, morning stiffness, and muscle weakness are also frequently observed. Pain that initially occurs during activity may progress to pain at rest as the disease advances, making it one of the leading reasons for clinical visits.

According to 2019 data, approximately 528 million individuals worldwide were living with osteoarthritis, representing a 113% increase since 1990. Nearly 73% of patients with osteoarthritis are over 55 years of age, and approximately 60% are women. As osteoarthritis is more common among older adults (with about 70% of cases occurring in individuals over 55 years of age), global prevalence is expected to rise with population aging. Based on data from the Turkish Statistical Institute (TUIK), 11.2% of the population in Türkiye reported arthritis-related problems in 2019.

Several risk factors contributing to the development and progression of OA have been identified. The onset and progression of the disease are influenced by genetics, age, sex, nutrition, obesity, bone density, joint stress resulting from sports activities, smoking, ethnicity, physical inactivity, occupational joint strain, and trauma. Moreover, more than 25% of osteoarthritis cases are accompanied by comorbid conditions such as obesity, diabetes, pulmonary and cardiovascular diseases, hypertension, metabolic and musculoskeletal disorders, and depression. The chronic pain and stiffness experienced by individuals with osteoarthritis lead to physical limitations that impair daily living activities, result in inadequate self-care, deteriorate functional status, disrupt social relationships, and ultimately contribute to decreased quality of life. Age-related increases in musculoskeletal conditions within society negatively affect functional capacity, quality of life, and healthcare costs. Education, weight management, and regular exercise are effective strategies for improving quality of life. Challenges in nutrition, transportation, elimination, and social interaction further impair quality of life among older individuals. Therefore, improving quality of life should be prioritized in the self-management of osteoarthritis.

Although there is no direct cure for osteoarthritis, treatment strategies aim to reduce symptoms, slow disease progression, minimize the negative impact on mobility and quality of life, and lessen healthcare needs. Pharmacological treatments include analgesics, anti-inflammatory agents, and opioids, while surgical interventions involve arthroscopy, osteotomy, and total knee replacement. Non-pharmacological therapies constitute one of the strongly recommended components in osteoarthritis management, particularly in knee osteoarthritis, as emphasized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Strongly recommended approaches include patient education, weight loss when applicable, and structured exercise programs consisting of aerobic and strengthening exercises, alongside lifestyle modifications. Additionally, modalities suggested by the European League Against Rheumatism (EULAR)-such as laser therapy, spa therapy, pulsed electromagnetic field therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS), herbal remedies, and vitamin supplementation-are commonly used non-pharmacological treatment options.

Herbal remedies are widely recommended as complementary and supportive treatments in many healthcare systems across the world. Some self-care guidelines frequently advise the use of bandages or compresses for osteoarthritis symptoms. Among these traditional practices, cabbage leaf compresses have been used for centuries. Leaves from white or Savoy cabbage are applied to the painful knee joint for several hours to reduce pain. The health-promoting properties of cabbage leaves have long been recognized, and they have been used to treat various conditions, including breast engorgement. Cabbage leaves are rich in dietary fiber, vitamin C, vitamin K, folate, manganese, iodine, potassium, beta-carotene, and calcium. They are also known to possess strong antioxidant, anticancer, and anti-inflammatory properties. The sulfur compounds in cabbage leaves are believed to help alleviate pain and swelling. Their analgesic effects are attributed to physiological mechanisms such as dilation of capillaries, reduction of tissue congestion, decreased edema, localized anesthetic effects, and reduction in muscle spasticity and stiffness.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Experiencing knee pain due to osteoarthritis for at least 6 months
  • Diagnosed with knee osteoarthritis by a physician according to the American College of Rheumatology (ACR) criteria
  • Having a pain score of 4 or higher on the Visual Analog Scale (VAS)
  • Aged 18 years or older
  • No allergy to cabbage or other herbal products
  • Able to speak Turkish and having no communication difficulties
  • Volunteering to participate in the study

排除标准

  • Those with poor mental status
  • Those using pain-relieving medication during the cabbage leaf application period
  • Those with a history of surgical operation on the application area (knee region) within the past year
  • Those with infection, wounds, cellulitis, or skin disease in the application area
  • Those with any peripheral vascular disease in the application area
  • Those who have experienced significant knee trauma within the past six months
  • Those who have received intra-articular steroid injections within the past six months
  • Those with inflammatory joint disease
  • Those who developed knee osteoarthritis due to injury or infection
  • Those with pain related to secondary arthritis (e.g., post-traumatic or inflammatory arthritis)
  • Those with asthma, liver, or kidney disease
  • Pregnant or breastfeeding women
  • Those with psychological or physical disorders
  • Those with physical disabilities in the lower extremities
  • Patients who do not agree to participate in the study will not be included in the sample.

研究组 & 干预措施

The effect of cabbage leaves on knee pain

Experimental

The sequence order was generated by computer (Research Randomizer software, version 1.0.0). Unstratified block randomization with varying block sizes will be used to assign patients to three groups. Subsequently, a non-participating staff member will be asked to draw one number from an envelope containing numbers 1 to 90, each representing a patient. The group assignment of the drawn number will determine the patient's group. Using this method, patients will be randomly assigned to the groups.

Patients who apply cabbage leaves kept at room temperature, as determined by the literature, will form Experimental Group 1; those who apply traditionally prepared cabbage leaves will form Experimental Group 2; and those who do not receive any cabbage leaf application will form the Control Group.

干预措施: Cabbage leaf compress for knee pain (Other)

结局指标

主要结局

Change in Knee Pain Severity

时间窗: 1 month

Description: Knee pain severity will be measured using the Visual Analog Scale/VAS (0-10). Change in VAS pain score from baseline to Week 4 will be assessed. Unit of Measure: Points on a 0-10 scale

Change in Physical Function

时间窗: 1 month

Description: Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale. Change from baseline to Week 4 will be evaluated. Unit of Measure: Points on WOMAC scale (0-96)

Change in Quality of Life

时间窗: 1 month

Description: Quality of Life in Lower Extremity Osteoarthritis (MiniOAKHQoL-TR) questionnaire will be used for measurement. Change from baseline to week 4 will be evaluated. Unit of Measure: Quality of Life in Lower Extremity Osteoarthritis (MiniOAKHQoL-TR) scores (0-200)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serap Parlar Kılıç

Prof.Dr

Inonu University

研究点 (1)

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