Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 142
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
Cupping therapy is an ancient complementary medicine therapy. It was a cornerstone in many ancient healing systems, including Traditional Chinese Medicine, Unani Medicine, Traditional Korean Medicine, and Islamic Medicine. Previous pilot randomized controlled trials reported promising effects of adding cupping therapy in the management of tinnitus and hearing loss. This trial aims to evaluate the safety and efficacy of wet cupping as a complementary treatment in the management of chronic subjective tinnitus with or without hearing loss. Materials and Methods: The study participants will be 142 patients suffering from subjective and continuous tinnitus aged from 21 to 65 years. Participants will be randomly assigned into an interventional group (71) or a control group (71). This study is a randomized controlled study. All participants will read and sign the informed consent. Intention to treat and changes in the Tinnitus Handicap Inventory (THI) between groups will be the primary outcome. Hearing Level (HL) and adverse events related to wet cupping will be the secondary outcomes. Data will be collected on required forms. Statistical analysis will also be performed. Descriptive analysis will also be represented, showing the demographic information. This clinical trial is a large clinical trial which will be based on a previously conducted pilot trial at Hamad Medical Corporation (HMC).
详细描述
Wet Cupping therapy (WCT): One of the complementary and integrative medicine healing practices, which uses cups with superficial scarifications of the selected points on the skin.
Tinnitus was defined as the perception of a sound without an associated known stimulus consciously.
In spite of several work and research studies, the pathophysiology of Tinnitus is still unclear. Tinnitus is one of the major audiological symptoms. Despite its huge personal and presumed economic impact, there are only limited therapeutic options available. The reason for this deficiency lies in the very nature of the disease as it is deeply connected to elementary plasticity of auditory processing in the central nervous system. Furthermore, tinnitus with unknown causes was classified as subjective tinnitus, and if tinnitus duration was more than six months, it was classified as chronic tinnitus. One of the major challenges in tinnitus is to explore the pathophysiological causes to find an appropriate effective treatment.
Cupping therapy is an integrative and complementary medicine practice. Cupping therapy types were numerous, and there was a published classification of cupping therapy types. Wet cupping therapy is one of the technical types of cupping therapy. Wet cupping was practiced by applying cups on selected body points. Superficial scarifications should be performed by using a sterile surgical blade after removing the cups. The cups should be re-applied again. Cupping therapy showed promising and significant effects in the management of various diseases such as: headache, migraine, neck pain, low back pain, and knee osteoarthritis. A previous case report and a pilot study were conducted to evaluate the safety and efficacy of cupping therapy in the management of tinnitus and dizziness. The promising effects and the wide safety profile of wet cupping therapy were reported in this study. Furthermore, wet cupping therapy reduced the discomfort of tinnitus and dizziness. Evidently, cupping therapy was reported to have a wide safety profile as shown in previous published systematic reviews.
Tinnitus Handicap Inventory (THI) uses validated tinnitus questionnaires, is a self-administered test that is used to help determine the degree of distress suffered by the tinnitus patient. It is widely used in medical offices and in clinical trials to determine the effectiveness of a given therapy. The purpose of this questionnaire is to identify difficulties that may be experienced because of tinnitus, focused instead on the impact of tinnitus on a person's activities of daily living. The THI is the most recent, most reliable, and most widely used of several questionnaires developed over the last 20 years.
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
- Single (Outcomes Assessor)
盲法说明
- Data analysts will be blinded to treatment assignment until statistical analysis completion
- Independent statisticians will conduct all analyses using coded group identifiers
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 21 to 65 years old.
- •Primary subjective tinnitus with or without hearing loss for more than 6 months.
- •Tinnitus significantly impacting quality of life, as measured by the Tinnitus Handicap Inventory (THI).
排除标准
- •Objective, acute or intermittent tinnitus.
- •History of Ménière's disease.
- •Tinnitus induced by cerebellopontine angle tumors.
- •Cardiovascular disease, or a serious medical or mental illness.
- •History of central nervous system disease.
- •Patient with anemia or cardiovascular diseases.
- •Current pregnancy or breast-feeding.
- •Patients with a lack of willingness or availability.
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: The scale will be performed at baseline, and end of treatment at 8 weeks
A 25-item instrument designed to evaluate the handicap experienced by an individual due to tinnitus.
次要结局
- Hearing Level (HL) :(The scale will be performed at baseline, and end of treatment at 8 weeks)
- Adverse events.(Adverse events will be checked up to 8 weeks from baseline.)