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临床试验/NCT06298760
NCT06298760已完成不适用

The Effect of Foot Reflexology and Knee Massage Applied With Black Cumin Extract Oil on Pain and Fatigue Symptoms in Elderly People With Knee Osteoarthritis

Erzurum Technical University2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2019年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Pain Score

研究概览

简要总结

In this study, black cumin extract oil was used in elderly individuals with Knee Osteoarthritis (OA). The effects of foot reflexology and knee massage on pain and fatigue symptoms. It is aimed to examine and research which of these two applications is more effective.The study, planned as a randomized controlled experimental study, included a total of 150 participants.

The data consists of participants who receive outpatient treatment in the Physical Therapy and Rehabilitation Unit at a university hospital, are over 65 years old, and have no problems with their perception after the Mini Mental Test. After randomization, participants were divided into five groups, with 30 participants in each group. Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups.

详细描述

Osteoarthritis (OA) is an insidiously progressive disease that causes structural destruction in the joints, cartilage tissue and subchondrial bone, inflammation in the synovial tissue and consequently osteophyte formations; It is an irreversible, degenerative joint disease.Its incidence increases with age and it is the second most common disease in 50% of individuals over the age of 65.It is also the most common cause of chronic pain, fatigue, functional disability, physical disability and limitation in individuals in this age group.The primary complaint of patients with knee OA is pain. Pain is usually; It is seen in intraarticular and periarticular regions. Pain is initially intermittent, mild, and limited to the joint area. In the later stages of the disease, the pain is deep, aching and intense.Although patients experience difficulty in their daily living activities due to pain, the main reason why they cannot perform their activities is pain-related fatigue. Although there is no evidence level method to modify the deformations that occur in the joint structure in OA, various treatment methods are available. The primary goal of treatment in individuals with knee OA is to reduce pain, relieve fatigue, prevent deformations and maintain the patients' independence. There are important clinical guidelines for these goals. According to the guidelines in the treatment of osteoarthritis; Classified in 5 Categories: Pharmacological Treatments, Non-Pharmacological Treatments, Intra-artricular Treatments, Surgical Treatments and Complementary and Integrated Treatments (CAM). According to literature reviews, the most frequently used methods by OA patients include aromatherapy, massage and reflexology, and massages generally include black cumin, olive oil, lavender, rosemary, ginger, etc. It is observed that the oils are applied by rubbing them into the knee and these applications reduce pain and fatigue.Black Cumin; The most important active ingredient is thymoquinone (TQ). Thymoquinone is an important component due to its effect on reducing joint inflammation and rheumatic pain, and this feature makes this oil preferred in aromatherapy.Massage; It is defined as a manual work that helps symptom management and control by creating external rhythmic and impulsive pressure on the soft tissues in the body in order to maintain the health of the body and to support healing in case of disease, especially by helping the circulatory system.Reflexology; projection of glands and organs in the body; It corresponds to reflex points on the hands, feet and ears. It is defined as an application aimed at ensuring that body activities are at an optimum level by stimulating these specific points with unique manipulative techniques through the hands. Ease of application of OA patients in addition to standard treatment It will be beneficial for patients to know and use aromatherapy, massage and reflexology methods that will not cause difficulties in terms of accessing and accessing materials.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with knee OA
  • Staged according to Kellgren-Lawrence Gonarthrosis staging and Stage 2 and above
  • Open to communication and without cognitive problems
  • Those aged 65 and over
  • Not allergic to the essential oil used
  • Those who have no open wounds on their knees or feet and have not undergone any surgery
  • VAS- Pain and Fatigue Severity score of 4 and above
  • Mini Mental Test (MMT) score >25
  • People who agreed to participate in the research were included in the study.

排除标准

  • not meeting the inclusion criteria
  • Patients who did not agree to participate in the study were not included in the study

研究组 & 干预措施

Knee Massage With Black Cumin Oil Group

Experimental

Necessary explanations were made to the patients in this group. Before application, 5 drops of black cumin oil were applied to the patient's knee for 20 minutes. waited. After making sure that there was no allergy, both knees were massaged with oil for a total of 30 minutes.

干预措施: Knee Massage With Black Cumin Oil Group: (Combination Product)

Placebo Knee Massage Application Group

Placebo Comparator

Patients in this group received a 30-minute knee massage with pure petroleum jelly.

干预措施: placebo group (Combination Product)

Foot Reflexology Group With Black Cumin Oil

Experimental

Patients in this group underwent foot reflexology with pure black cumin oil for 40 minutes on both feet.

干预措施: Foot Reflexology Group With Black Cumin Oil (Combination Product)

Placebo Foot Reflexology Group

Placebo Comparator

Patients in this group underwent foot reflexology with vaseline for 40 minutes on both feet.

干预措施: placebo group (Combination Product)

Control Group

No Intervention

No intervention was performed on patients in this group. Followed for 6 weeks. Face-to-face meetings were held once a week.

结局指标

主要结局

Pain Score

时间窗: 6 weeks

visual analog scale:VAS: It is a scale scored between 0 and 10 points. A score of 0 indicates that the patient has no pain, and a score of 10 indicates that the patient has unbearable pain. The patient gives a score between 0 and 10 depending on the pain condition.

次要结局

  • fatigue severity(6 weeks)

研究者

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

Ercan Bakır

assoc prof

Erzurum Technical University

研究点 (2)

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