Efficacy of Multimodal Interventions for Tenosynovitis: Comparative Analysis of Basic Manipulation, Tui Na, Blood Flow Restriction Training, and Magnetic Bead Application Combined With Tui Na
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Visual Analogue Scale, VAS
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of four treatments in patients with hand tenosynovitis. The main questions it aims to answer are:
Which treatment most effectively reduces pain and improves joint function? How do the treatments differ in improving strength and range of motion? Researchers will compare four groups-basic manipulation, tui na manipulation, blood flow restriction (BFR) training, and magnetic bead application combined with tui na-to see if there are differences in clinical outcomes.
Participants will:
Be randomly assigned to one of the four treatment groups. Receive interventions twice a week for 4-8 weeks. Undergo assessments of pain, function, range of motion, and strength before, during, and after the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years of age.
- •Case diagnosis reporting symptoms of tenosynovitis of the hand for at least 3 months.
- •Constant-Murley Shoulder Score: score less than or equal to
- •Dysfunction of the Upper Extremity, Shoulder, and Hand Scale (DASH Scale): DASH score less than
- •Mayo Wrist Score: score less than or equal to
- •Positive test results on 2 or more scales during pre-test screening.
- •No structural lesions or congenital malformations of the hand or wrist.
- •Finkelstein's Test: Positive (pain occurs when patient holds thumb and bends wrist toward little finger).
- •Fist Clenching Test: Positive (pain increases when patient clenches fist and attempts to bend wrist toward little finger).
- •No prior hand or wrist surgery or external injuries.
- •No serious cardiac, pulmonary, neurological, or other systemic diseases.
- •Sufficient exercise capacity to complete exercise loads of required intensity and duration.
排除标准
- •Not between 18 and 60 years of age.
- •Failed wrist function screening.
- •Failed special tests.
- •Presence of structural wrist lesions or congenital wrist deformities.
- •History of wrist surgery, significant trauma, or wounds.
- •Problems with skin irritation, infections, or open wounds.
- •Conditions like anemia or low blood pressure.
- •Serious cardiac, pulmonary, neurological, or other systemic diseases.
- •Inability to cooperate with trial requirements or refusal to participate.
结局指标
主要结局
Visual Analogue Scale, VAS
时间窗: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
The VAS score consists of five dimensions of pain threshold testing: overall wrist pain, pain when extending the wrist, pain when flexing the wrist, wrist pain when resisting forearm rotation, and pain when pressing on specific parts of the wrist. Each dimension is scored on a scale of 0-10 for a total of 50 points, with lower scores indicating less pain.
Mayo Wrist Score, MWS
时间窗: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
The scale consists of four areas: pain (25 points), function (25 points), range of motion (25 points), and grip strength (25 points) for a total of 100 points, with higher scores indicating better wrist function.
Wrist strength
时间窗: Baseline, 4 weeks (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
An electronic grip strength device was used to measure the grip strength of the affected arm before and after the treatment, including the grip strength of the affected arm in three states; the maximum grip strength in the naturally hanging arm state, the maximum grip strength in resisted internal rotation of the forearm, and the maximum grip strength in resisted external rotation of the forearm.
Range of Motion Measurement
时间窗: Baseline, 4 weeks, (after Week 4 of treatment), 8 weeks (after the final treatment at Week 8)
Flexion and extension angle measurements, forearm pronation and pronation angle measurements
次要结局
未报告次要终点
研究者
Zixin Deng
Sponsor-Investigator
First People's Hospital of Foshan