Pain ManagementNCT03582059
Electroencephalographic Changes in Spinal Cord Stimulation
A study testing High Frequency Spinal cord stimulation and Burst Frequency Spinal cord stimulation in people with Pain Management, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Spinal cord stimulation by means of an electrode in the back is used to treat patients with persistent chronic pain after back surgery. Based on the stimulation patterns, there are mainly three different technologies available - conventional, burst frequency and the high frequency. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain Management
- What is being tested?
- High Frequency Spinal cord stimulation and Burst Frequency Spinal cord stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2017to 1 Dec 2019
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I. Patient is 18 years of age or older and has given written informed consent. II. Has persistent chronic predominant low back pain of neuropathic origin, with or with out radiculopathy, for a minimum of 6 months as per NICE Tag 0159. III. Patient has had previous spinal surgery at least > 6 months ago. IV. Numerical rating scale Scale (NRS) back pain score of at least 5 at baseline V. Confirmation of pain from neuropathic origin as per NICE guidance TAG 0159 VI. Total daily dose of opioids equivalent to ≤120mg of Morphine VII. In the investigators opinion the patient is a suitable candidate for SCS. VIII. Patient is willing to comply with the requirements of the study
Who cannot join
- I. Patient has mechanical spine instability based on flexion/extension testing of lumbar spine (documented in the last 6 months) II. Patient is pregnant, or pregnancy is suspected or planned within the first six months of the study timeframe.
- Patient has a cardiac pacemaker, automatic defibrillator, or any other implanted device, which will make the trial impossible. IV. Allergy to device components or drugs to be used in the intended procedure. V. Medical co-morbidities that preclude surgical intervention. VI. Patient is incapable of understanding or responding to the study questionnaires VII. Patient is incapable of understanding or operating the patient programmer handset.
- Patient is morbidly obese (BMI ≥ 40). IX. Patient is simultaneously participating in another device or drug study within the last 30 days.
- Patient is on more than 120 mg of morphine a day. XI. Patient has a spinal fracture, tumour or infection. XII. Clinical evidence of cauda equina syndrome. XIII. Progressive neurologic deficit. XIV. Patient has epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double Blind, Cross Over, Pilot Study to Evaluate EEG Changes in Patients' Undergoing Spinal Cord Stimulation(SCS) With High Frequency and Burst Frequency for Failed Back Surgery Syndrome(FBSS).
Spinal cord stimulation by means of an electrode in the back is used to treat patients with persistent chronic pain after back surgery. Based on the stimulation patterns, there are mainly three different technologies available - conventional, burst frequency and the high frequency. It is known that the traditional frequency works through the lateral system of pain pathways in the spinal cord to cause pain reduction. Electroencephalographic(tracing of brain activity) recording of patients using burst have shown an additional effect on an adjacent medial pain pathway which decreases the attention to pain. We want to therefore find out if high frequency stimulation also has an effect on the same pathways. 20 patients who have persistent neuropathic chronic pain after previous spinal surgery, would be eligible to have this treatment as part of their normal care. They will be randomly chosen to undergo a 2 week cycle of high frequency and 2 weeks of burst stimulation. We will record EEG's, pain scores and scores measuring attention to pain and compare findings. All patients will be recruited at the Leeds Pain and Neuromodulaton centre and the EEg analysis will be done by a research team based in Belgium. We hope that the study will improve our understanding of how different stimuation waveforms used for spinal cord stimulation work. We hope to have recruited all 20 patients in a 12 month period.
- Conditions
- Pain Management
- Being tested
- High Frequency Spinal cord stimulation, Burst Frequency Spinal cord stimulation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Frequency Spinal cord stimulationProcedure or surgery
An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of high frequency stimulation.
Burst Frequency Spinal cord stimulationProcedure or surgery
An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of burst frequency stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Patient group meeting inclusion criteria group 1 | Other | Patients meeting the inclusion criteria in the first 10 days of entering trial and are randomised to first intervention. Receives: Procedure: High Frequency Spinal cord stimulation; Procedure: Burst Frequency Spinal cord stimulation |
| Patient group meeting inclusion criteria group 2 | Other | Patient group meeting inclusion criteria after 10 days and are allocated second intervention. Receives: Procedure: High Frequency Spinal cord stimulation; Procedure: Burst Frequency Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrencephalographic patterns generated
Pain measured according to pain vigilance and awareness questionnaire (PVAQ)
Measured: 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Apr 2017
- Primary completion16 Oct 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single blind, randomized cross over study at a single centre
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582059
- Sponsor's protocol ID
- PM16/84656
- Status last verified
- Aug 2019
- First submitted
- 23 Sep 2016
- Last updated
- 13 Aug 2019
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Cross Over, Pilot Study to Evaluate EEG Changes in Patients' Undergoing Spinal Cord Stimulation(SCS) With High Frequency and Burst Frequency for Failed Back Surgery Syndrome(FBSS).
- ClinicalTrials.gov ID
- NCT03582059
- Acronym / sponsor ID
- PM16/84656
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 10 Jul 2018 (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.
Spinal cord stimulation by means of an electrode in the back is used to treat patients with persistent chronic pain after back surgery. Based on the stimulation patterns, there are mainly three different technologies available - conventional, burst frequency and the high frequency. It is known that the traditional frequency works through the lateral system of pain pathways in the spinal cord to cause pain reduction. Electroencephalographic(tracing of brain activity) recording of patients using burst have shown an additional effect on an adjacent medial pain pathway which decreases the attention to pain. We want to therefore find out if high frequency stimulation also has an effect on the same pathways. 20 patients who have persistent neuropathic chronic pain after previous spinal surgery, would be eligible to have this treatment as part of their normal care. They will be randomly chosen to undergo a 2 week cycle of high frequency and 2 weeks of burst stimulation. We will record EEG's, pain scores and scores measuring attention to pain and compare findings. All patients will be recruited at the Leeds Pain and Neuromodulaton centre and the EEg analysis will be done by a research team based in Belgium. We hope that the study will improve our understanding of how different stimuation waveforms used for spinal cord stimulation work. We hope to have recruited all 20 patients in a 12 month period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind, randomized cross over study at a single centre
| Arm | Type | Receives |
|---|---|---|
| Patient group meeting inclusion criteria group 1 | Other | Procedure: High Frequency Spinal cord stimulation, Procedure: Burst Frequency Spinal cord stimulationPatients meeting the inclusion criteria in the first 10 days of entering trial and are randomised to first intervention. |
| Patient group meeting inclusion criteria group 2 | Other | Procedure: High Frequency Spinal cord stimulation, Procedure: Burst Frequency Spinal cord stimulationPatient group meeting inclusion criteria after 10 days and are allocated second intervention. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- I. Patient is 18 years of age or older and has given written informed consent. II. Has persistent chronic predominant low back pain of neuropathic origin, with or with out radiculopathy, for a minimum of 6 months as per NICE Tag 0159. III. Patient has had previous spinal surgery at least > 6 months ago. IV. Numerical rating scale Scale (NRS) back pain score of at least 5 at baseline V. Confirmation of pain from neuropathic origin as per NICE guidance TAG 0159 VI. Total daily dose of opioids equivalent to ≤120mg of Morphine VII. In the investigators opinion the patient is a suitable candidate for SCS. VIII. Patient is willing to comply with the requirements of the study
Key exclusion criteria (4 listed)
- I. Patient has mechanical spine instability based on flexion/extension testing of lumbar spine (documented in the last 6 months) II. Patient is pregnant, or pregnancy is suspected or planned within the first six months of the study timeframe.
- Patient has a cardiac pacemaker, automatic defibrillator, or any other implanted device, which will make the trial impossible. IV. Allergy to device components or drugs to be used in the intended procedure. V. Medical co-morbidities that preclude surgical intervention. VI. Patient is incapable of understanding or responding to the study questionnaires VII. Patient is incapable of understanding or operating the patient programmer handset.
- Patient is morbidly obese (BMI ≥ 40). IX. Patient is simultaneously participating in another device or drug study within the last 30 days.
- Patient is on more than 120 mg of morphine a day. XI. Patient has a spinal fracture, tumour or infection. XII. Clinical evidence of cauda equina syndrome. XIII. Progressive neurologic deficit. XIV. Patient has epilepsy.
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 |
|---|---|---|
| High Frequency Spinal cord stimulationAn electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of high frequency stimulation. | Procedure or surgery | Patient group meeting inclusion criteria group 1, Patient group meeting inclusion criteria group 2 |
| Burst Frequency Spinal cord stimulationAn electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of burst frequency stimulation. | Procedure or surgery | Patient group meeting inclusion criteria group 1, Patient group meeting inclusion criteria group 2 |
Primary outcome
Electrencephalographic patterns generated
Time frame: 60 mins
Pain measured according to pain vigilance and awareness questionnaire (PVAQ)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- 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?
A study testing High Frequency Spinal cord stimulation and Burst Frequency Spinal cord stimulation in people with Pain Management, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Electrencephalographic patterns generated (time frame: 60 mins). 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 13 Aug 2019.