Chronic PainNCT05411419
Retrospective Analysis of Spinal Cord Stimulation on Chronic Non-cancer Pain
An observational study of Chronic Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Spinal cord stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data of all patients underwent SCS between 2014 to 2021 for non-cancer pain management kept in the Pain Clinic, Queen Mary Hospital would be retrieved.
Who may be able to join
- all patients underwent SCS for chronic non-cancer pain management between 2014 to 2021 in Queen Mary Hospital
Who cannot join
- missing of essential data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Cord Stimulation for the Management of Chronic Non-cancer Pain: a Retrospective Study
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.
Read the detailed 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.
- Conditions
- Chronic Pain
- Being tested
- Spinal cord stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationProcedure or surgery
Two leads for spinal cord stimulation would be implanted.
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Pain score using numerical rating scale (NRS) from 0 to 10, 0 represents no pain, and 10 represents the worst pain.
Measured: At 1 week after implant of spinal cord stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chi-Wai Cheung, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411419
- Sponsor's protocol ID
- UW22-507
- Status last verified
- May 2024
- First submitted
- 5 Jun 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation for the Management of Chronic Non-cancer Pain: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05411419
- Acronym / sponsor ID
- UW22-507
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data of all patients underwent SCS between 2014 to 2021 for non-cancer pain management kept in the Pain Clinic, Queen Mary Hospital would be retrieved.
Key inclusion criteria (1 listed)
- all patients underwent SCS for chronic non-cancer pain management between 2014 to 2021 in Queen Mary Hospital
Key exclusion criteria (1 listed)
- missing of essential data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal cord stimulationTwo leads for spinal cord stimulation would be implanted. | Procedure or surgery | – |
Primary outcome
pain score
Time frame: At 1 week after implant of spinal cord stimulation
Pain score using numerical rating scale (NRS) from 0 to 10, 0 represents no pain, and 10 represents the worst pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: At 1 week after implant of spinal cord stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.