Randomised, Multicentre, Open Label, Parallel Group Pragmatic Clinical Trial of Local Steroid Injection Versus Night Splinting in Mild to Moderate Carpal Tunnel Syndrome (CTS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
研究概览
简要总结
Carpal Tunnel Syndrome (CTS) is a common condition in which a nerve (known as the median nerve) is squeezed where it passes through the wrist. It can cause pain or aching, tingling or numbness in the affected hand. It may disturb sleep, or affect ability to do day to day things.
There have been several studies into the best treatment of patients with severe symptoms of CTS who are referred to a hospital for treatment. However, little is known about the best treatments for patients with mild to moderate symptoms who visit their GP but do not require hospital treatment.
The study will investigate whether a steroid injection is clinically effective in reducing symptoms and improving function in the short term (6 weeks) compared to a night splint in people consulting with mild to moderate CTS in primary care.We will study the effects of these 2 treatments over 6 weeks and at 6 months. Subject to further funding, the Study will also look at whether these 6 weeks of treatment are effective 1 year and 2 years later.
The study will take place in up to 50 GP practices and hospital clinics across the UK. Patients aged 18 and over who have been diagnosed with mild to moderate CTS which has been present for at least 6 weeks will be eligible for inclusion.
The steroid is a drug called "DepoMedrone." This drug is already widely used to treat CTS. In this study, one injection will be given. The splint is made of elastic and has an aluminium bar which sits on the palm of the hand. In this study, the splint will be worn at night for 6 weeks. Each participant will receive either a single steroid injection or a splint, and will be asked to complete up to 5 questionnaires over 2 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18 years
- •A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria
- •Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
- •Symptom duration of episode of at least 6 weeks
- •Written informed consent provided by the patient, prior to any trial specific procedures
排除标准
- •Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
- •Any previous surgery on the affected wrist
- •Severe CTS exhibiting constant numbness or pain, constant sensory loss, severe thenar muscle atrophy or symptom severity which requires the patient to be referred for a surgical opinion
- •Clinical suspicion of local or systemic sepsis or infection
- •Current or previous infection of the affected wrist
- •Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
- •Unable to tolerate the study interventions
- •Unable to understand and complete self-report questionnaires written in English
- •Inter-current illness including, but not limited to:
- •poorly controlled thyroid disease
- •poorly controlled diabetes mellitus
- •vibration-induced neuropathy
- •inflammatory joint disease
- •suspected complex neurological conditions
- •any other severe medical illness which in the opinion of the local Principal Investigator (or other authorised clinical delegate) precludes trial participation
- •Pregnant or lactating females
- •Receiving anticoagulants
- •Any history of hypersensitivity to Depo-Medrone or any of its excipients
- •Allergy to any of the splint materials
- •Known abuse of drugs or alcohol
- •Involved in on-going litigation cases for their condition
研究组 & 干预措施
Steroid Injection
Single steroid injection into Carpal Tunnel (as Depo-medrone 20mg)
干预措施: Depo-Medrone (Drug)
Wrist Splint
Wrist splint to be worn at night
干预措施: Wrist Splint (Device)
结局指标
主要结局
Symptom Severity and Limitations in Hand Function as Assessed by the BCTQ 6 Weeks
时间窗: 6 weeks
Comparison of overall BCTQ between treatment groups at 6 weeks follow-up (scale 1-5, higher score indicates more severe symptoms and functional impairment). BCTQ: Boston Carpal Tunnel Questionnaire
次要结局
- Hand-wrist Pain Intensity Over 24 Months: 6 Months(6 months)
- Hand-wrist Pain Intensity 6 Weeks (PP)(6 weeks)
- BCTQ Functional Limitations Subscale 6 Weeks(6 weeks)
- Surgery 6 Weeks(6 weeks)
- BCTQ Symptom Severity and Functional Limitations 6 Months(6 months)
- BCTQ Functional Limitations Subscale 6 Months(6 months)
- Referral to Surgery 6 Months(6 months)
- Surgery 6 Months(6 months)
- BCTQ Symptom Severity Subscale 6 Weeks(6 weeks)
- Hand-wrist Pain Intensity 6 Weeks(6 weeks)
- Hand-wrist Pain Intensity 6 Months(6 months)
- Insomnia Due to Hand-wrist Problems 6 Months(6 months)
- BCTQ Functional Limitations Subscale 6 Weeks (CC)(6 weeks)
- Hand-wrist Pain Intensity 6 Weeks (CC)(6 weeks)
- BCTQ Symptom Severity and Functional Limitations 6 Months (CC)(6 months)
- Herbal Remedies and Vitamin Use 6 Months (CC)(6 months)
- Over the Counter Pain Medication 6 Months (CC)(6 months)
- Prescribed Pain Medication 6 Months (CC)(6 months)
- BCTQ Symptom Severity Subscale 6 Months(6 months)
- Over the Counter Pain Medication 6 Months(6 months)
- Prescribed Pain Medication 6 Months(6 months)
- BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Weeks(6 weeks)
- Hand-wrist Pain Intensity Over 24 Months: 24 Months(24 months)
- Insomnia Due to Hand-wrist Problems 6 Weeks(6 weeks)
- Referral for Surgery 6 Weeks(6 weeks)
- Herbal Remedies and Vitamin Use 6 Months(6 months)
- BCTQ Symptom Severity and Functional Limitations Over 24 Months: 6 Months(6 months)
- BCTQ Symptom Severity and Functional Limitations Over 24 Months: 12 Months(12 months)
- Secondary: BCTQ Symptom Severity and Functional Limitations Over 24 Months: 24 Months(24 months)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (Complete Case Analysis (CC))(6 weeks)
- BCTQ Symptom Severity Subscale 6 Weeks (CC)(6 weeks)
- Hand-wrist Pain Intensity Over 24 Months: 6 Weeks(6 weeks)
- Hand-wrist Pain Intensity Over 24 Months: 12 Months(12 months)
- Insomnia Due to Hand-wrist Problems 6 Weeks (CC)(6 weeks)
- BCTQ Symptom Severity Subscale 6 Months (CC)(6 months)
- Hand-wrist Pain Intensity 6 Months (CC)(6 months)
- Referral to Surgery 6 Months (CC)(6 months)
- BCTQ Symptom Severity Subscale 6 Weeks (PP)(6 weeks)
- BCTQ Functional Limitations Subscale 6 Months (PP)(6 months)
- BCTQ Functional Limitations Subscale 6 Weeks (PP)(6 weeks)
- Referral to Surgery at 6 Months (PP)(6 months)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not State a Preference of Intervention)(6 weeks)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Splint)(6 weeks)
- BCTQ Functional Limitations Subscale 6 Months (CC)(6 months)
- Insomnia Due to Hand-wrist Problems 6 Weeks (PP)(6 weeks)
- BCTQ Symptom Severity and Functional Limitations 6 Months (PP)(6 months)
- BCTQ Symptom Severity Subscale 6 Months (PP)(6 months)
- Insomnia Due to Hand-wrist Problems 6 Months (CC)(6 months)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (Per-Protocol Analysis (PP))(6 weeks)
- Hand-wrist Pain Intensity 6 Months (PP)(6 months)
- Herbal Remedies and Vitamin Use 6 Months (PP)(6 months)
- Prescribed Pain Medication 6 Months (PP)(6 months)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (Subgroup Analysis (SG), Intervention of Their Preference)(6 weeks)
- NHS Cost Differences at 6 Months (CC)(6 months)
- NHS Cost Differences at 12 Months(12 months)
- NHS Cost Differences at 24 Months(24 months)
- QALYS at 12 Months (Cross-walk Tariff)(12 months)
- Insomnia Due to Hand-wrist Problems 6 Months (PP)(6 months)
- Over the Counter Pain Medication 6 Months (PP)(6 months)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Preferred Injection)(6 weeks)
- NHS Cost Differences at 6 Months(6 months)
- BCTQ Symptom Severity and Functional Limitations 6 Weeks (SG, Did Not Receive the Intervention of Their Preference)(6 weeks)
- QALYS at 6 Months (Cross-walk Tariff)(6 months)
- QALYS at 24 Months (Cross-walk Tariff)(24 months)