Steroid injection versus surgical decompression for carpal tunnel syndrome

Not Applicable

Completed

• Conditions: Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic bone disease; Nervous System Diseases; Carpal tunnel syndrome

• Registration Number: ISRCTN59894749
• Lead Sponsor: Gloucestershire Hospitals NHS Foundation Trust

Brief Summary

2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/28451442 2020 letter in https://pubmed.ncbi.nlm.nih.gov/32501127/ (added 22/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-20
• Study Completion: 2017-10-31
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. All three of the following must be present:
1.1. Intermittent paraesthesia in median nerve distribution
1.2. Nocturnal hypoaesthesia, dysaesthesia or paraesthesia (including on waking)
1.3. A positive provocation test (e.g. Tinel’s, Phalen’s, Durkin’s pressure or hand elevation test)
2. Symptoms present for at least 3 months
3. Patients’ symptoms must either:
3.1. Disturb their sleep
3.2. Limit their ability to perform work or activities of daily living
4. Patients must have failed a trial of night splints for at least 2 weeks
5. Age >18 years

Exclusion Criteria

1. Severe CTS
1.1. Thenar muscle wasting or
1.2. Continuously reduced light touch sensation in median nerve distribution (compared to opposite unaffected side or unaffected finger)
2. Previous carpal tunnel surgery or steroid injection (either side)
3. CTS secondary to:
3.1. Wrist deformity, trauma or mass
3.2. Pregnancy
3.3. Hypothyroidism
3.4. Inflammatory arthropathy
4. Clinical or neurophysiological evidence of polyneuropathy or cervical radiculopathy
5. Other symptomatic disorder in the affected hand diagnosed in the last 6 months or requiring treatment.
6. Patients in whom the baseline questionnaire cannot be completed due to cognitive difficulties

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Feasibility outcomes:<br> 1. Eligibility rate is measured by recruitment numbers and screening logs during the recruitment phase<br> 2. Recruitment rate is measured by the number of patients randomised to the trial and over what period of time<br> 3. Adherance rate is measured by the number of withdrawals and losses to follow up over the 12 month period of the follow up process<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pain and function is measured using the Carpal Tunnel Assessment Questionnaire at baseline, 1, 3, 6 and 12 months<br> 2. Pain is measured using the Palmar Pain scale at baseline, 1, 3, 6 and 12 months<br> 3. Quality of Life is measured using the Global Outcome Scale and the EuroQol- 5D at baseline, 1, 3, 6 and 12 months<br> 4. How satisfied patients are with their treatment outcome is measured using the Satisfaction Scale at 6, 12 months<br> 5. Time off work/activities is measured by patient reports on resources use, complications and any further treatment sought at baseline, 1, 3, 6 and 12 months<br>