Specialty: Musculoskeletal disorders, Primary sub-specialty: Metabolic bone disease Nervous System Diseases Carpal tunnel syndrome
Conditions
Interventions
Participants are randomised to one of two groups using a web-based randomisation system will be provided by the Oxford Clinical Trials Research Unit (OCTRU). A computer will generate the random sequen
Sponsors
Gloucestershire Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. Eligibility rate is measured by recruitment numbers and screening logs during the recruitment phase 2. Recruitment rate is measured by the number of patients randomised to the trial and over what period of time 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain and function is measured using the Carpal Tunnel Assessment Questionnaire at baseline, 1, 3, 6 and 12 months 2. Pain is measured using the Palmar Pain scale at baseline, 1, 3, 6 and 12 months 3. Quality of Life is measured using the Global Outcome Scale and the EuroQol- 5D at baseline, 1, 3, 6 and 12 months 4. How satisfied patients are with their treatment outcome is measured using the Satisfaction Scale at 6, 12 months 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 | — |
Countries
United Kingdom
Contacts
Public ContactCushla Cooper
Outcome results
None listed