Pre-operative electrical stimulation in carpal tunnel syndrome
- Conditions
- Carpal tunnel syndrome scheduled to undergo primary surgical decompressionNervous System Diseases
- Registration Number
- ISRCTN94245451
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1. MRI parameters of median nerve at the carpal tunnel at baseline and 3 months<br>2. Median nerve sensory and motor conduction studies including motor unit number estimation (assessed by M-Scan method) and axonal excitability<br>3. Boston Carpal Tunnel Syndrome questionnaire at 12 months<br>4. Visual analogue rating of symptoms at 12 months<br>5. iHand nerve function questionnaire at 12 months<br>6. painDETECT questionnaire at 12 months<br>7. Neuropathic Pain symptom Inventory at 12 months<br>8. Depression Anxiety Positive Outlook Scale at 12 months<br>9. Short-form pain Anxiety Symptoms Scale at 12 months<br>10. Insomnia Severity Index at 12 months<br>11. EQ-5D-5L at 12 months<br>12. Global Rating of Change questionnaire at 12 months<br>13. Quantitative sensory testing (German Research Network for Neuropathic Pain short form protocol) at baseline and 6 months<br>14. Histological parameters of median nerve innervated skin biopsy at baseline and 6 months