Back PainPROCONCT02549183
Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes
A study testing Boston Scientific PRECISION Spinal Cord Stimulator System in people with Back Pain and Neuralgia, run by Mid and South Essex NHS Foundation Trust at 3 sites in United Kingdom.
Trial summary
Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Boston Scientific PRECISION Spinal Cord Stimulator System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Jun 2015to 13 Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
- Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
- No back surgery within 6 months prior to Screening.
- Average low back pain intensity, during the position/activity, which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale during Baseline period based on eDiary.
- If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening to a total of less than 180 mg Oral Morphine equivalent
- Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock from the Baseline visit through End of Rate Randomization and protocol required stimulation parameter locks, complete daily eDiary).
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- 18 years of age or older when written informed consent is obtained.
- If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening.
- Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
- Baseline Oswestry Disability Index score ≥ 20 and ≤ 80.
- Received at least 30 per cent reduction in NRS of average low back pain intensity from Baseline during the end of Post Implant HF10 Sweet-Spot Search as recorded in the eDiary.
Who cannot join
- Average worst leg pain intensity is greater than average worst low back pain intensity as reported during Baseline period based on eDiary.
- Radiographic evidence of spinal instability requiring fusion.
- Primary pain complaint of vascular origin (e.g. peripheral vascular disease).
- Spinal pain secondary to neoplasm, infection, autoimmune disorder with spinal involvement, or a spinal metabolic disorder.
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment might confound reporting of study outcomes (e.g. pelvic pain, angina pain, chronic migraine.
- Participating (or intends to participate) in another clinical study.
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- Terminal illness with anticipated survival 1 year.
- Current condition associated with risk of immunocompromised that might increase risk of infection during study duration.
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
- Are pregnant/lactating or not using adequate birth control.
- Have untreated major psychiatric comorbidity, serious drug related behaviour issues.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
North Bristol NHS Trust
Bristol, Avon, BS10 5NB
South Tees NHS Foundation Trust
Middlesbrough, TS4 3BW
Orsett Hospital
Orsett, Essex, RM16 3EU
About this study
Official title: Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10KHz Frequency - a Feasibility Study
Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain.
Read the detailed description
This is a feasibility study to identify the optimal frequency for stimulation of the spinal cord to achieve maximum reduction in neuropathic back pain as measured by average Numerical rating Scale.
Twenty patients who suffer from back more than leg pain will be recruited into the study once they have satisfactory pain relief from both low and high frequency stimulations. Each patient will then receive stimulation at four different frequencies for 2-3 weeks in a random and blinded order. Their pain scores and function will be assessed using a variety of different tools. The data will then be used to estimate the optimal frequency.
- Being tested
- Boston Scientific PRECISION Spinal Cord Stimulator System
- Keywords
- Spinal Cord Stimulation
- Medical subject headings
- Back Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific PRECISION Spinal Cord Stimulator SystemDevice
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to A KHz Receives: Device: Boston Scientific PRECISION Spinal Cord Stimulator System |
| Arm 2 | Active comparator | Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to B KHz Receives: Device: Boston Scientific PRECISION Spinal Cord Stimulator System |
| Arm 3 | Active comparator | Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to C KHz Receives: Device: Boston Scientific PRECISION Spinal Cord Stimulator System |
| Arm 4 | Active comparator | Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to D KHz Receives: Device: Boston Scientific PRECISION Spinal Cord Stimulator System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain relief
Mean reported pain on Numerical Rating Scale (NRS)
Measured: Three months
Secondary outcomes (4)
Leg pain relief
Mean reported pain on Numerical Rating Scale (NRS)
Measured: 3-6 months
Patient global impression of change at end of Long-Term Follow-up
Questionnaire
Measured: 6-9 months
Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up
Questionnaire
Measured: 6-9 months
Change in activities of Daily Living related to back pain disability from Baseline visit to end of Long-Term Follow-up
Questionnaire
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study start1 Jun 2015
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- North Bristol NHS Trust
- Responsible party
- Sponsor
- Investigators
- Simon Thomson, MD, Study chair, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549183
- Sponsor's protocol ID
- B726
- Acronym
- PROCO
- Status last verified
- Dec 2020
- First submitted
- 1 Sep 2015
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thomson SJ, Tavakkolizadeh M, Love-Jones S, Patel NK, Gu JW, Bains A, Doan Q, Moffitt M. Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation. 2018 Jan;21(1):67-76. doi: 10.1111/ner.12746. Epub 2017 Dec 8.
PubMed 29220121
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10KHz Frequency - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02549183
- Acronym / sponsor ID
- PROCO / B726
- Keywords
- Spinal Cord Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- North Bristol NHS Trust
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 15 Sep 2015 (estimated)
- 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.
Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain.
Detailed description
This is a feasibility study to identify the optimal frequency for stimulation of the spinal cord to achieve maximum reduction in neuropathic back pain as measured by average Numerical rating Scale.
Twenty patients who suffer from back more than leg pain will be recruited into the study once they have satisfactory pain relief from both low and high frequency stimulations. Each patient will then receive stimulation at four different frequencies for 2-3 weeks in a random and blinded order. Their pain scores and function will be assessed using a variety of different tools. The data will then be used to estimate the optimal frequency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Boston Scientific PRECISION Spinal Cord Stimulator SystemBoston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to A KHz |
| Arm 2 | Active comparator | Device: Boston Scientific PRECISION Spinal Cord Stimulator SystemBoston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to B KHz |
| Arm 3 | Active comparator | Device: Boston Scientific PRECISION Spinal Cord Stimulator SystemBoston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to C KHz |
| Arm 4 | Active comparator | Device: Boston Scientific PRECISION Spinal Cord Stimulator SystemBoston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to D KHz |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
- Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
- No back surgery within 6 months prior to Screening.
- Average low back pain intensity, during the position/activity, which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale during Baseline period based on eDiary.
- If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening to a total of less than 180 mg Oral Morphine equivalent
Key exclusion criteria (11 listed)
- Average worst leg pain intensity is greater than average worst low back pain intensity as reported during Baseline period based on eDiary.
- Radiographic evidence of spinal instability requiring fusion.
- Primary pain complaint of vascular origin (e.g. peripheral vascular disease).
- Spinal pain secondary to neoplasm, infection, autoimmune disorder with spinal involvement, or a spinal metabolic disorder.
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment might confound reporting of study outcomes (e.g. pelvic pain, angina pain, chronic migraine.
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 |
|---|---|---|
| Boston Scientific PRECISION Spinal Cord Stimulator SystemSpinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz. | Device | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Back pain relief
Time frame: Three months
Mean reported pain on Numerical Rating Scale (NRS)
4 secondary outcomes
Leg pain relief
Time frame: 3-6 months
Patient global impression of change at end of Long-Term Follow-up
Time frame: 6-9 months
Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up
Time frame: 6-9 months
Change in activities of Daily Living related to back pain disability from Baseline visit to end of Long-Term Follow-up
Time frame: 6-9 months
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 22 Dec 2020.
- Results publication: PubMed 29220121Thomson SJ, Tavakkolizadeh M, Love-Jones S, Patel NK, Gu JW, Bains A, Doan Q, Moffitt M. Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation. 2018 Jan;21(1):67-76. doi: 10.1111/ner.12746. Epub 2017 Dec 8.
- 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.
Simon Thomson, MD study chair
National Health Service, United Kingdom
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific PRECISION Spinal Cord Stimulator System in people with Back Pain and Neuralgia, run by Mid and South Essex NHS Foundation Trust at 3 sites 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 11 inclusion and 11 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Back pain relief (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549183, which also lists 1 linked publication.
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 22 Dec 2020.