Specialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management
Conditions
Interventions
Participants are randomly allocated to groups. Randomisation is achieved by means of a password-protected web-based system developed and maintained by Exeter Clinical Trials Unit (ExeCTU). Once the pa
Sponsors
James Cook University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (=18 years) who are clinically considered to be candidates for SCS as per NICE TA159 2. Pain of neuropathic nature of an intensity of at least 5 as assessed on a numerical rating scale (NRS) 3. Patient has persistent pain for more than 6 months despite appropriate conventional medical and surgical management including (TENS), acupuncture, oral analgesic agents, cognitive behavioural therapy as well as nerve blockade where appropriate 4. Satisfactory multidisciplinary assessment by a team with expertise in delivering SCS therapy 5. Capable of providing informed consent
Exclusion criteria
Exclusion criteria: 1. Patient refusal to participate in the study 2. Presence of an on-going pain condition considered by the investigator to overshadow the neuropathic pain condition to be treated with SCS 3. Current or previous treatment with an implanted pain relief device 4. Current participation or planned participation in other studies that may confound the results of this study 5. Ongoing anticoagulation therapy, which cannot be safely discontinued 6. Poor cognitive ability 7. Unable to undergo study assessments or complete questionnaires independently 8. Patient is pregnant or planning to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured on a Numerical Rating Scale (NRS) at 6 months, with a minimal clinically important difference (MCID) of 2 points between the two randomised treatment arms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients achieving at least 50% and 30% pain relief at 6 months, measured on the NRS at baseline, 3 and 6 months 2. Health related quality of life is measured using the EQ-5D-5L at baseline, 3 and 6 months 3. Function is measured using the Oswestry Disability Index (ODI) questionnaire at baseline, 3 and 6 months 4. Patient satisfaction is measured using the Patients’ Global Impression of Change (PGIC) questionnaire at 3 and 6 months 5. Complication rates are measured using Adverse Events recording at each visit 6. Patients' views of the screening trial, implantation and overall use of the device, assessed using a semi-structured interview for 30 patients (10 at each centre) at baseline and 1 month post implant by telephone | — |
Countries
England, United Kingdom
Outcome results
None listed