Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05411419 |
Other study ID # |
UW22-507 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 1, 2022 |
Est. completion date |
December 31, 2022 |
Study information
Verified date |
May 2024 |
Source |
The University of Hong Kong |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Since 2014, the Queen Mary Hospital, a tertiary teaching hospital in Hong Kong, has commenced
the provision of spinal cord stimulation (SCS) services with structured guidelines,
standardized protocols and comprehensive pre- and post-operative assessments. It is hoped
that the needs of chronic pain patients, especially those who are refractory to conventional
medical management, can be better addressed with the introduction of SCS. Hence, through the
proposed retrospective study, the investigator aim to systematically evaluate the use of SCS
in Queen Mary Hospital, thereby providing evidence with regard to its efficacy and safety for
pain management.
Description:
As one of the most common health complaints in the world, low back pain (LBP) can affect
people across all age groups, with a lifetime prevalence of 84%. In Hong Kong LBP is reported
to be the second most prevalent illness due to work and the most common illness made worse by
work. LBP can be acute or chronic, with the former lasting less than six weeks and the latter
lasting more than twelve weeks. LBP is believed to have an adverse impact on quality of life
and functional performance, creating social and economic costs.
Current guidelines on the management of chronic LBP generally recommend the use of
conservative treatments, pharmacological agents and/or invasive treatments. Non-steroidal
anti-inflammatory drugs (NSAIDs) are commonly used in pharmacologic therapy, while
conservative treatments such as supervised exercise therapy and cognitive behavioural therapy
are other possible therapeutic options. If necessary, more invasive treatments including
epidural corticosteroids, intra-articular steroid injections and spinal cord stimulation may
be considered.
With the advances in neuromodulation in recent decades, spinal cord stimulation (SCS) has
become a well-established therapeutic modality for the treatment of chronic pain. Through the
delivery of electrical stimulation to the dorsal column of the spinal cord, SCS modulates the
pain signals and replaces the pain sensation with tingling paraesthesia for pain relief.
Evidence-based guidelines published by the Neuromodulation Appropriateness Consensus
Committee (NACC) of the International Neuromodulation Society recommend the use of SCS for a
variety of chronic pain conditions, which include failed back surgery syndrome (FBSS),
complex regional pain syndrome (CRPS), upper extremity neuropathic pain syndrome, chronic
refractory angina and ischemic peripheral neuropathic pain.
Yet the effectiveness of SCS on chronic non-cancer pain management is still unknown in Hong
Kong.