The TRIAL-STIM Study

Not Applicable

Completed

• Conditions: Specialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management; UKCRC code/ Disease: Neurological/ Nerve, nerve root and plexus disorders; Surgery; Anaesthesia

• Registration Number: ISRCTN60778781
• Lead Sponsor: James Cook University Hospital

Brief Summary

2018 protocol in https://www.ncbi.nlm.nih.gov/pubmed/30446003 2020 results in https://pubmed.ncbi.nlm.nih.gov/32618875/ (added 14/01/2021) 2020 results in https://pubmed.ncbi.nlm.nih.gov/33258531/ (added 14/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-15
• Study Completion: 2019-12-02
• Last Update Posted: 25 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 107

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified