The clinical and cost effectiveness of of a steroid injection versus a night splint for Carpal Tunnel Syndrome

Phase 4

Completed

• Conditions: Topic: Primary Care, Musculoskeletal disorders; Disease: All Diseases, Musculoskeletal Pain Disorders; Nervous System Diseases; Carpal tunnel syndrome; Subtopic: Not Assigned, Musculoskeletal (all Subtopics)

• Registration Number: ISRCTN09392969
• Lead Sponsor: niversity of Keele (UK)

Brief Summary

1. 2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27716159 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30343858

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-01
• Study Completion: 2018-12-31
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom severity and limitations in hand function as assessed by the Boston CTS questionnaire; Timepoint(s): 6 weeks, 6 months, 12 months and 24 months post-randomisation.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration