Evaluation of wrist splinting for the treatment of carpal tunnel syndrome

Not Applicable

Completed

• Conditions: Carpal tunnel syndrome; Nervous System Diseases

• Registration Number: ISRCTN81836603
• Lead Sponsor: Region Skåne

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-02
• Study Completion: 2022-12-31
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Change in CTS symptoms, measured with the 6-item CTS symptoms scale at baseline, 6 weeks and 12 weeks<br> 2. Rate of surgery at 52 weeks, measured in percent (proportion of patients that had surgery within 52 weeks)<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. TS symptoms, measured with the 6-item CTS symptoms scale score at 52 weeks<br> 2. Activity limitations, measured with the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale score at baseline, 12 weeks and 52 weeks<br> 3. Health status and quality of life, measured with the EQ-5D index at baseline, 12 weeks and 52 weeks<br> 4. Grip strength, measured with the Jamar dynamometer at baseline and 52 weeks<br> 5. Patient satisfaction, measured with the visual analogue scale (VAS) at 12 weeks and 52 weeks<br> 6. Palmar pain, measured with the 2-item palmar pain scale at 52 weeks<br> 7. Time to surgery, measured in weeks, within 52 weeks<br> 8. Duration of sick leave, measured in days/weeks/months during 52 weeks<br> 9. Adverse events<br>