Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger. A Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS pain
研究概览
简要总结
Patients aged 18-75 years who present with trigger finger to a tertiary rehabilitation hospital and agree to participate will be included in the study. Participants will be randomly allocated into three groups using block randomization. The first group will use a static finger splint that blocks the proximal interphalangeal joint for 6 weeks, along with a home exercise program. The second group will receive paraffin bath therapy, and the third group will receive peloidotherapy, both in combination with home exercises.
All patients will receive education about the disease and activity modification. The finger joint-restricting splint and exercises will be applied for 6 weeks. Evaluations will be conducted at baseline, at the end of the 3rd week, and at the end of the 6th week by a blinded assessor. No analgesic or anti-inflammatory medication will be permitted during the study, and patients will be instructed to avoid using analgesics within 24 hours prior to each assessment.
详细描述
Patients aged between 18 and 75 years who were diagnosed with trigger finger and agreed to participate in the study will be included. A total of 60 patients who have applied to the Physical Medicine and Rehabilitation outpatient clinics of the University of Health Sciences Beyhekim Training and Research Hospital will be enrolled. According to the inclusion and exclusion criteria, eligible and willing participants will be randomly assigned to three groups using block randomization.
The first group will be instructed to use a static finger splint that blocks the proximal interphalangeal joint for 6 weeks and will also follow a home exercise program. The second group will receive paraffin bath therapy for 20 minutes per day, 15 sessions over 3 weeks, together with a home exercise program. The third group will receive peloidotherapy at 45°C for 20 minutes per day, consisting of 15 sessions over 3 weeks, in conjunction with a home exercise program.
A static finger splint that restricts the proximal interphalangeal joint and maintains it in extension will be provided to the patients. They will be instructed to wear the splint continuously during both day and night, removing it only for hygiene or essential needs. The splint will be worn for 6 weeks until the completion of the study, and the daily duration of splint use will be recorded for each patient.
The home exercise program will include finger passive and active range of motion exercises (passive fist-making and active range of motion without triggering), tendon gliding, self-administered gentle A1 pulley stretching, and gentle deep circular massage. The exercises will be demonstrated to each patient in practice by a physician or physiotherapist and taught using printed visual materials. Patients will be specifically instructed, encouraged, and monitored to ensure exercise adherence. Those with an adherence rate below 70-75% will be excluded from the study.
All patients will receive education about the disease and will be advised on activity modification. Evaluations will be performed before treatment, at the end of the 3rd week, and at the end of the 6th week. A blinded assessor will conduct detailed examinations and evaluate the groups in terms of the study's primary and secondary outcome measures.
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 (Investigator, Outcomes Assessor)
盲法说明
single blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between 18 and 75 years of age and willing to participate in the study
- •Having a diagnosis of idiopathic single trigger finger, Grade 2-3
排除标准
- •Patients with triggering in more than one finger
- •Patients with triggering at the A3 pulley or with Grade 1 or Grade 4 trigger finger
- •Patients with thumb (pollex) trigger finger
- •Patients who have undergone any injection or interventional procedure (release surgery) for trigger finger within the past 6 months
- •Patients who have received physical therapy for the hand within the past 6 months
- •Patients currently using corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Patients with inflammatory or autoimmune rheumatologic diseases such as rheumatoid arthritis, systemic lupus erythematosus, gout, or psoriatic arthritis
- •Patients with other musculoskeletal disorders (e.g., carpal tunnel syndrome, de Quervain's tenosynovitis, symptomatic hand osteoarthritis, or Dupuytren's contracture) or neurological diseases (e.g., stroke-related hemiparesis, spinal cord injury, brachial plexus injury, multiple sclerosis, or Parkinsonism) affecting the same hand
- •Patients with musculoskeletal disorders causing pain and/or limitation in the proximal upper extremity on the affected side (e.g., periarthritis, lateral epicondylitis, mononeuropathy, or radiculopathy)
- •Patients with significant metabolic diseases (e.g., hypothyroidism, Cushing's syndrome, or uncontrolled diabetes)
- •Patients with any condition that may interfere with treatment, such as open wounds, rashes, local infections, or active malignant disease of the hand
- •Patients with a history of hand trauma (chronic or repetitive)
- •Patients unwilling to complete the self-assessment questionnaires either independently or with assistance
- •Pregnant women
研究组 & 干预措施
Peloidotherapy
The group receiving peloidotherapy
干预措施: Peloidotherapy (Other)
Paraffin bath
The group receiving paraffin bath therapy
干预措施: Paraffin bath (Other)
Finger orthosis
The group receiving the finger joint-blocking orthosis
干预措施: Finger orthosis (Device)
结局指标
主要结局
VAS pain
时间窗: Baseline, week 3 and week 6
VAS pain: 0 no pain; 10 unbearable/max. pain.
Green's classification (Grades 1-4)
时间窗: Baseline, week 2 and week 6
Trigger finger classified according to Green's classification (Grades 1-4) Grade 1 - Pretriggering: Pain in the palm and tenderness over the A1 pulley, with a history of triggering not demonstrable on examination. Grade 2 - Active Triggering: Triggering is clinically evident, but the patient can actively extend the finger. Grade 3 - Passive Triggering: 3a: Locking is present and requires passive extension. 3b: Locking is present, and the patient cannot actively flex the finger. Grade 4 - Contracture: The finger is completely locked with a fixed flexion contracture at the PIP joint.
Michigan Hand Outcomes Questionnaire (MHQ)
时间窗: Baseline, week 2 and week 6
The Michigan Hand Outcomes Questionnaire (MHQ) is a comprehensive self-reported questionnaire developed to evaluate hand function, pain, and patient satisfaction. It is used to assess the functional status of individuals with upper extremity disorders and consists of six subscales: Overall Hand Function, Activities of Daily Living, Work Performance, Pain, Aesthetics, and Satisfaction. The Turkish version of the MHQ has undergone linguistic and cultural adaptation processes, and its validity and reliability have been established. Studies have demonstrated that the Turkish MHQ has high internal consistency and test-retest reliability, supporting its use in both clinical practice and research for assessing hand and wrist problems. The MHQ is scored on a scale ranging from 1 to 100. Except for the pain subscale, higher scores indicate better hand function and satisfaction, whereas higher pain scores represent greater pain intensity. The overall hand health status is determined by cal
次要结局
- Ultrasonographic evaluation of the trigger finger(Baseline, week 2 and week 6)
- Patient Global Impression of Change(Week 2 and week 6)
研究者
Ramazan Yılmaz, MD
Associate Prof (MD)
Konya Beyhekim Training and Research Hospital