The clinical and cost effectiveness of of a steroid injection versus a night splint for Carpal Tunnel Syndrome: a pragmatic randomised trial in primary care

niversity of Keele (UK)0 个研究点目标入组 240 人开始时间: 2014年5月1日最近更新: 2019年4月8日

适应症

试验速览

•1. Male or female aged 18 years or over
•2. A clinical diagnosis of unilateral or bilateral CTS as made by a GP or trained clinician according to the diagnostic criteria
•3. Mild (e.g. intermittent paraesthesia) or moderate (e.g. constant paraesthesia, reversible numbness and / or pain) severity CTS of idiopathic nature
•4. Symptom duration of episode of at least 6 weeks
•5. Written informed consent provided by the patient, prior to any trial specific procedures

•1. Steroid injection or night splints for CTS in the affected wrist within preceding 6 months
•2. Any previous surgery on the affected wrist
•3. 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
•4. Clinical suspicion of local or systemic sepsis or infection
•5. Current or previous infection of the affected wrist
•6. Trauma to the affected hand requiring surgery or immobilisation in the previous 12 months
•7. Unable to tolerate the study interventions
•8. Unable to understand and complete self report questionnaires written in English
•9. Intercurrent 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
•10. Pregnant or lactating females
•11. Receiving anticoagulants
•12. Any history of hypersensitivity to DepoMedrone or any of its excipients (refer to the Summary of Product Characteristics (SPC)
•13. Allergy to any of the splint materials (refer to manufacturer?s specification)
•14. Known abuse of drugs or alcohol
•15. Involved in ongoing litigation cases for their condition

发起方

niversity of Keele (UK)