A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord Stimulatio

Not Applicable

Completed

• Conditions: Chronic primary back pain; Anaesthesiology - Pain management; Neurological - Other neurological disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619001139167
• Lead Sponsor: Genesis Research Services

Brief Summary

Spinal cord stimulation (SCS) is an advanced treatment option that can help to relieve chronic back pain. Not all who try SCS get pain relief. Sometimes the pain returns and SCS no longer helps. For these patients, an alternative option is to try targeted drug delivery therapy. Strong pain medication (typically morphine) is delivered directly to the space around the spinal cord by an implanted drug pump device. In this study, we recruited patients who “failed” SCS therapy to try “low dose” drug delivery therapy. Eligible patients were implanted with a drug pump and followed-up for 12-months. The study included nine patients. At 4-months, three patients reported at least 50% pain relief. Four patients left the study after this due to lack of pain relief or a medical problem. Of the remaining five patients, three patients reported at least 50% pain relief at the end of the study and said they were “much improved” or “very much improved”. During the study, 16 medical problems were recorded that were “probably” related to the study. These included pain or headache after the implant surgery, increased sweating, diarrhoea/constipation, and difficulty urinating. One patient had a serious medical problem that required hospital care (wound infection) and left the study. In conclusion, the study showed that some patients who have tried SCS therapy without success may get pain relief with targeted drug delivery therapy, however, further trials are needed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-15
• Study Completion: 2022-02-03
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Appropriate candidate for TDD therapy
- Failed SCS within the last 5 years prior to enrolment
- If currently on systemic opioid medication, be willing to taper medication to 20mg or lower (morphine equivalent) per day prior to implant
- Be willing to cease use of any SCS/PNS device for study duration

Exclusion Criteria

- Medical condition or pain in other area(s), that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints according to the Investigator
- Meets any contraindication for pump implantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean pain intensity score (VAS) from baseline (pre-systemic opioid medication wean, if required)[ 4-months post-implant]

Secondary Outcome Measures

Name	Time	Method
Change in mean pain intensity score (VAS) from baseline after systemic opioid medication wean to a dose of 20mg/day or less (morphine equivalent)[ 1-, 4-, 6-, 12-months post-implant];Change in mean quality of life score (EQ-5D) from baseline[ 1-, 4-, 6-, 12-months post-implant];Change in mean Brief Pain Inventory (BPI) from baseline[ 1-, 4-, 6-, 12-months post-implant];Change in mean health status score (SF-36) from baseline[ 1-, 4-, 6-, 12-months post-implant];Change in systemic opioid dose (pre-opioid wean, if required) from baseline[ 1-, 4-, 6-, 12-months post-implant];Patient Global Impression of Change (PGIC)[ 1-, 4-, 6-, 12-months post-implant];Clinician Global Impression of Change (CGIC)[ 1-, 4-, 6-, 12-months post-implant];Participant-reported adverse events (e.g.: pain at implant site, infection, headaches, respiratory depression, nausea, drowsiness) [ 1-, 4-, 6-, 12-months post-implant]