Injection Versus Splinting in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome (CTS)
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Intervention: Depo-Medrone; Wrist Splint
Intervention description: Steroid Injection; Simple wrist splint
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hand; wrist; carpal; tunnel; syndrome; pragmatic; randomised; steroid; splint

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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