Analysis of Hyperthermia as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Carpal Tunnel Syndrome: a Double-blind Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Neuropathic Pain Scale (DN4)
研究概览
简要总结
This project aims to analyze the use of hyperthermia within a treatment protocol for Carpal Tunnel Syndrome (CTS), as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the hand flexor muscles and neural stretching, the application of hyperthermia to the carpal tunnel and adjacent areas, and the use of a night splint. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure hand flexor muscle strength and wrist free range of motion. Subjective variables will also be used through validated questionnaires covering physical activity, perceived functional limitations, upper limb functional assessment, neuropathic pain, and a visual analogue scale for pain perception.
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
- Double (Participant, Investigator)
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
- •Have a diagnosis confirmed by performing an electromyography of Carpal Tunnel Syndrome
- •Have not yet received physiotherapy treatment.
排除标准
- •Have undergone surgery.
- •Those who refuse to participate in this study.
- •Patients with muscle atrophy due to CTS.
- •Medical conditions that are contraindications for hyperthermia therapy.
研究组 & 干预措施
Hyperthermia 2 times per week
干预措施: hyperthermia (Radiation)
Hyperthermia 2 times per week
干预措施: physical exercise (Other)
Hyperthermia 2 times per week
干预措施: splint (Other)
Hyperthermia 3 times per week
干预措施: hyperthermia (Radiation)
Hyperthermia 3 times per week
干预措施: physical exercise (Other)
Hyperthermia 3 times per week
干预措施: splint (Other)
Non-hyperthermia 2 times per week
干预措施: physical exercise (Other)
Non-hyperthermia 2 times per week
干预措施: splint (Other)
Non-hyperthermia 3 times per week
干预措施: physical exercise (Other)
Non-hyperthermia 3 times per week
干预措施: splint (Other)
结局指标
主要结局
Neuropathic Pain Scale (DN4)
时间窗: Baseline and up to one year
Minimum: 0 Maximum: 10 The diagnosis of neuropathic pain is established with a total scale of 4 out of 10
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
时间窗: Baseline and up to one year
Minimum: 19. Maximum: 95. A higher score indicates a higher degree of disability
Disabilities of arm, shoulder and hand (DASH)
时间窗: Baseline and up to one year
Minimum: 30 points. Maximum: 150 points A higher score indicates a higher intensity of symptoms
International Physical Activity Questionnaire (IPAQ)
时间窗: Baseline and up to one year
9 items. Minimum: 9 Maximum: 36 A higher score indicates a sedentary life
Visual Analogue Scale (VAS)
时间窗: Baseline and up to one year
Minimum: 1 Maximum: 10 A higher score indicates a higher intensity of pain
Hand grip strength
时间窗: Baseline and up to one year
A handheld dynamometer will be used and three consecutive measurements will be obtained with the patient sitting and the elbow flexed at 90 degrees and in a neutral position.
WRIST JOINT RANGE OF MOBILITY
时间窗: Baseline and up to one year
With the patient seated in a relaxed position, the various free movements of the wrist joint will be assessed bilaterally using an electronic goniometer. To do this, the goniometer will be placed on the dorsal side of the wrist, with the proximal part on the midline between the radius and ulna and the distal part on the third metacarpal. Flexion, extension, and radial and ulnar deviation ranges will be assessed, both with the elbow flexed and extended.
WRIST FLEXION EVALUATION TEST
时间窗: Baseline and up to one year
With the patient seated in a relaxed position, wrist flexion will be tested in isometric contraction, both with the hand open and closed, and with the wrist in a neutral position. The therapist will manually resist wrist flexion from the hand area. This test will be performed three times in a row with the hand open, followed by a five-minute rest and then repeating the procedure, this time with the hand open. This measurement will be taken with the elbow flexed or extended.
次要结局
未报告次要终点
研究者
Dr. Manuel González-Sánchez
Principal Investigator
University of Malaga