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Clinical Trials/ISRCTN81836603
ISRCTN81836603Completed未知

Treatment of carpal tunnel syndrome with wrist splinting: a randomized controlled trial

Region Skåne0 sites142 target enrollmentStarted: May 2, 2018Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Enrollment
142

Study Overview

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31455398 protocol (added 29/08/2019)

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • Current inclusion criteria as of 04/06/2018:
  • 1. Primary, idiopathic carpal tunnel syndrome (CTS)
  • 2. Age 25-65 years, either sex
  • 3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram
  • 4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS
  • 5. Symptom duration of at least 1 month
  • Previous inclusion criteria:
  • 1. Primary, idiopathic carpal tunnel syndrome (CTS)
  • 2. Age 25-65 years, either sex
  • 3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram
  • 4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS
  • 5. Symptom duration of at least 1 month
  • 6. Symptom severity score at least 1.8 on the 6-item CTS symptoms scale (CTS-6)

Exclusion Criteria

  • 1. CTS classified as severe (thenar atrophy or 2-point discrimination exceeding 8 mm in at least 1 finger)
  • 2. Treatment of the study hand with a wrist splint in the past year
  • 3. Previous steroid injection for CTS in the study hand
  • 4. Inflammatory joint disease
  • 5. Vibration-induced neuropathy
  • 6. Polyneuropathy
  • 7. Current pregnancy
  • 8. Trauma to the study hand in the past year
  • 9. Previous CTS surgery in the study hand
  • 10. Inability to complete questionnaires due to language difficulties or cognitive disorder
  • 11. Severe medical illness
  • 12. Known abuse of drugs and/or alcohol

Investigators

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