Comparison of Static Hand-Wrist Splinting and Exercise Therapy in the Management of De Quervain's Tenosynovitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS pain
研究概览
简要总结
De Quervain's disease is a painful tenosynovitis of the abductor pollicis longus and extensor pollicis brevis muscle tendons located in the first dorsal compartment. The primary treatment for De Quervain's disease is conservative; surgical intervention is rarely required. Currently, there is no standardized treatment protocol supported by strong, up-to-date evidence.
The aim of this study is to compare the effectiveness of a static hand-wrist resting splint and exercise therapy in the conservative treatment of De Quervain's tenosynovitis. Patients will be evaluated in terms of pain levels, functional/symptom status, hand-finger strength, pressure pain threshold (PPT), tendon cross-sectional area measured by ultrasound, and the presence of effusion findings (semiquantitative; 0-3), and patient satisfaction.
详细描述
Patients who meet the inclusion and exclusion criteria will undergo a detailed clinical examination and medical history review, after which written informed consent will be obtained. They will then be randomly assigned to one of the two treatment groups using block randomization.
Baseline sociodemographic data (age, sex, body mass index, employment status, education level, marital status) and clinical variables (dominant hand, symptom duration, comorbidities, affected hand, presence of the Finkelstein sign, pain severity, functional/symptom status, hand-finger strength, pressure pain threshold (PPT), and ultrasonographic findings) will be recorded.
Patients in the first group will be provided with a static wrist-hand resting splint with thumb support, extending to the distal forearm. They will be instructed to wear the splint for at least 6-8 hours per day for a minimum of 4 weeks. Additionally, both groups will receive training on activity modification and positioning.
Patients in the second group will be given a home exercise program. They will perform the exercises twice daily for 6 weeks, with each exercise consisting of 10 repetitions. All patients will be evaluated at baseline, at the second week of treatment, and at the end of the sixth week.
Outcome measures will include clinical examination findings (Finkelstein test), pain severity [Visual Analog Scale (VAS) at rest and during activity], the Turkish versions of the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire, Health Assessment Questionnaire (HAQ), and Patient-Rated Wrist Evaluation (PRWE), patient satisfaction, handgrip and finger pinch strength measurements, and pain pressure threshold using an algometer.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 65 years
- •Patients experiencing wrist pain and tenderness for less than 3 months and clinically diagnosed with acute or subacute De Quervain's tenosynovitis
- •Visual Analog Scale (VAS) pain score ≥ 3
排除标准
- •History of trauma
- •Wrist fractures
- •Local infection
- •Presence of rheumatologic diseases (e.g., rheumatoid arthritis, psoriatic arthritis)
- •Presence of symptomatic hand osteoarthritis
- •Continuous use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids
- •Receipt of physical therapy for the hand or wrist within the past 3 months
- •Corticosteroid injection into the hand or wrist within the past 3 months
- •Diagnosed with significant neurological disorders (e.g., upper motor neuron disease)
- •Presence of uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus, congestive heart failure, chronic kidney disease, hepatic failure)
- •Major psychiatric disorders
- •Communication difficulties
结局指标
主要结局
VAS pain
时间窗: baseline, week 2 and week 6
VAS pain activity and rest: 0 no pain; 10 unbearable/max. pain.
Patient Rated Wrist Evaluation( PRWE)
时间窗: baseline, week 2 and week 6
The Patient-Rated Wrist Evaluation (PRWE) is a brief and effective self-report questionnaire that allows patients to assess their own wrist and hand problems. The PRWE consists of two main subscales: the Pain Subscale (0-50 points) and the Function Subscale (0-50 points). The total score ranges from 0 (no disability) to 100 (maximum pain and functional impairment).
The Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: baseline, week 2 and week 6
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a self-reported outcome measure used to assess the impact of upper extremity disorders on daily activities. It consists of 30 items, each scored on a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to perform). The total score ranges from 0 to 100, where 0 indicates no disability and 100 indicates severe functional limitation.
次要结局
- Hand grip strength(baseline, week 2 and week 6)
- Finger pinch strength(baseline, week 2 and week 6)
- Ultrasonographic evaluation of the first dorsal compartment tendons(Baseline, week 2 and week 6)
- Patient satisfaction(week 2 and week 6)
研究者
eda ünal madıoğlu
doctor
Konya Beyhekim Training and Research Hospital