Carpal tunnel syndrome scheduled to undergo primary surgical decompression Nervous System Diseases
Conditions
Interventions
PROSpeCT is a ‘randomised, patient-, surgeon- & assessor-blinded, placebo-controlled clinical trial’. This study design has been chosen as it will best allow us to determine whether the treatment make
hence they are blinded. The researchers measuring outcomes at follow-up will also be blinded. At the end of the study, results will be compared from the two groups to see if the electrical stimulation
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. Male or female, aged 18 years old and over 3. Diagnosed with carpal tunnel syndrome based on clinical examination by a hand surgeon 4. The patient has already determined they wish to proceed with carpal tunnel decompression surgery
Exclusion criteria
Exclusion criteria: The participant may not enter the study if ANY of the following apply: 1. Previous major hand, wrist surgery or forearm on the side affected by CTS, defined as previous carpal tunnel release, previous nerve repair, implantation of metalwork 2. Post-traumatic CTS 3. Previous electrical stimulation treatment of any kind, including implanted electrical stimulation devices such as cardiac pacemakers 4. Current pregnancy or CTS which developed during a previous pregnancy 5. Any peripheral neuropathy other than CTS 6. Another medical condition affecting the upper limb and neck (e.g., rheumatoid arthritis, cervical radiculopathy) 7. Diabetes mellitus 8. Hypothyroidism 9. Severe anxiety or depression 10. Conditions affecting pain perception (e.g. fibromyalgia) 11. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the Study, or may influence the result of the study, or the patient’s ability to participate in the study. 12. Evidence of motor conduction block across the carpal tunnel on neurophysiological testing 13. Patients with insufficient command of English to obtain consent from or to complete the study questionnaires. 14. Patients with insufficient mental capacity to obtain consent from or to complete the study questionnaires 15. Patients who in the opinion of the consultant in charge of their care, or the chief investigator, are unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cold detection threshold to a thermode (thermal probe) being placed on the skin measured using perception of ramped thermal stimuli at baseline pre-surgery and 6 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. MRI parameters of median nerve at the carpal tunnel at baseline and 3 months 2. Median nerve sensory and motor conduction studies including motor unit number estimation (assessed by M-Scan method) and axonal excitability 3. Boston Carpal Tunnel Syndrome questionnaire at 12 months 4. Visual analogue rating of symptoms at 12 months 5. iHand nerve function questionnaire at 12 months 6. painDETECT questionnaire at 12 months 7. Neuropathic Pain symptom Inventory at 12 months 8. Depression Anxiety Positive Outlook Scale at 12 months 9. Short-form pain Anxiety Symptoms Scale at 12 months 10. Insomnia Severity Index at 12 months 11. EQ-5D-5L at 12 months 12. Global Rating of Change questionnaire at 12 months 13. Quantitative sensory testing (German Research Network for Neuropathic Pain short form protocol) at baseline and 6 months 14. Histological parameters of median nerve innervated skin biopsy at baseline and 6 months | — |
Countries
England, United Kingdom
Contacts
Public ContactMax Stewart
Outcome results
None listed