Chronic PainProdigy-INCT02143791
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or Limbs
A study testing Burst and Tonic stimulation in people with Chronic Pain, run by Abbott Medical Devices at 21 sites in 9 countries.
Trial summary
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs. 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?
- Burst and Tonic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 21 sitesin 9 countries
- Study dates
- Jun 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
- Patient diagnosed with radiculopathy
- Patient diagnosed with neuropathic pain
- Patient is considered by the investigator as a candidate for implantation of a SCS system
- Patient is ≥ 18 years of age
- Patient must be willing and able to comply with study requirements
- Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form
Who cannot join
- Patient is diagnosed with ischemic pain
- Patient is diagnosed with arachnoiditis
- Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
- Patient is diagnosed with peripheral vascular disease (PVD)
- Patient is diagnosed with diabetic neuropathic pain
- Patient is diagnosed with chronic migraine
Show all 16Show fewer
- Patient is immune-compromised
- Patient has history of cancer requiring active treatment in the last 6 months
- Patient has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the last 6 months
- Patients with a SCS system or implantable infusion pump implanted previously
- Patient has a life expectancy of less than one year
- Patient is pregnant or is planning to become pregnant during the duration of the investigation
- Patient is unable to comply with the follow up schedule
- Patient needing legally authorized representative
- Patient unable to read and write
- Patient is currently participating in another clinical investigation with an active treatment arm.
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
Germany5 sites
Medizinische Einrichtungen der Universität zu Köln
Cologne
University Hospital
Düsseldorf
Hospital Gera
Gera, 07548
Universitätsklinik für Stereataktische Neurochirurgie
Magdeburg
Universitatsklinikum Tubingen
Tübingen, 72076
Australia3 sites
Metro Spinal Clinic
Caulfield, 3162
Frankston Pain Management
Frankston
Epworth Hospital
Richmond
Italy3 sites
Azienda Ospedaliera Monaldi
Naples
Az. Ospedaliero-Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126
Az. Osp.S.Giovanni Addolorata
Roma, 00184
Netherlands3 sites
Medisch Spectrum Twente
Enschede
St Antonius Ziekenhuis
Nieuwegein
Stichting Alysis Zorggroep
Velp
United Kingdom3 sites
Seacroft Hospital
Leeds, LS146UH
St Bartolomew's
London, EC 1A 7 BE
James Cook University Hospital
Middlesbrough
About this study
Official title: A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
- Conditions
- Chronic Pain
- Being tested
- Burst and Tonic stimulation
- Keywords
- SCS, Burst 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.
Burst and Tonic stimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Burst and Tonic stimulation | Experimental | All subjects were required to receive BurstDR stimulation therapy for the first 3 months after permanent implant. Thereafter the stimulation mode could be changed to tonic stimulation depending on patient's preference or physician's discretion. Receives: Procedure: Burst and Tonic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Overall VAS at 3 Months
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "[(post baseline baseline)/baseline] *100%" with positive numbers to represent increases and negative numbers to represent decreases.
Measured: 3 months
Secondary outcomes (8)
Pain Relief
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
Measured: 3 Months
Pain Relief
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain relief and 100% being complete pain relief.
Measured: 6 Months
Pain Relief
Patient reported pain relief. Patients were asked to evaluate their pain relief over the past week in percentage with 0% being no pain and 100% being complete pain relief.
Measured: 12 Months
Change in Pain Catastrophizing Scale
The pain catastrophizing scale (PCS) is a validated scale containing 13 items to assess thoughts and feelings about pain while a person is experiencing pain. The total of all 13 items results in a minimum of 0 and a maximum of 54; scores above 30 indicate clinically significant pain catastrophizing. The mean change was calculated based on the value at 12 months minus the value at baseline.
Measured: 12 Months
Number of Participants With Analgesic Reduction
Patient reported analgesic usage during the 4 weeks preceding the 12-month follow-up visit, compared to the baseline visit. The amount of patients who decreased the dose are reported.
Measured: 12 Months
Change in Quality of Life
Subjects were provided with the Euroqol-5 dimensions (EQ-5D) questionnaire at baseline and 12 Months follow-up visit. In that questionnaire, subjects were asked to indicate a score for their health on a scale where 100 would mean 'the best state he/she can imagine' and 0 would be the 'worst state he/she can imagine).
Measured: Baseline and 12 Months
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Adverse device effects were defined as adverse events related to the study procedures or the device. Serious events were those that resulted in-patient or prolonged hospitalization or were life-threatening.
Measured: from enrollment to 12 months follow up
Paresthesia Mapping at 3 Months Compared to the Empower Study
Paresthesia mapping is expressed in percent of paresthesia areas as indicated by the patient on a gender specific body diagram. 87 subjects with Burst stimulation at 3 Months (Prodigy-I) were compared to 134 subjects with tonic stimulation at 3 Months (Empower).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tony Van Havenbergh, Principal investigator, St Augustinus, Wilrijk, BelgiumDevyani Nanduri, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143791
- Sponsor's protocol ID
- NM-13-038-ID-SC
- Acronym
- Prodigy-I
- Status last verified
- Jan 2024
- First submitted
- 19 May 2014
- Last updated
- 8 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Study Evaluating the Prodigy Neuromodulation System for the Management of Failed Back Surgery Syndrome or Chronic Intractable Pain of the Trunk and/or Limbs.
- ClinicalTrials.gov ID
- NCT02143791
- Acronym / sponsor ID
- Prodigy-I / NM-13-038-ID-SC
- Conditions
- Chronic Pain
- Keywords
- SCS, Burst stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 8 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm long term efficacy and safety of the ProdigyTM neuromodulation system in the management of failed back surgery syndrome or chronic intractable pain of the trunk and/or limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burst and Tonic stimulation | Experimental | Procedure: Burst and Tonic stimulationAll subjects were required to receive BurstDR stimulation therapy for the first 3 months after permanent implant. Thereafter the stimulation mode could be changed to tonic stimulation depending on patient's preference or physician's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome or intractable low back and/or leg pain
- Patient diagnosed with radiculopathy
- Patient diagnosed with neuropathic pain
- Patient is considered by the investigator as a candidate for implantation of a SCS system
- Patient is ≥ 18 years of age
Key exclusion criteria (16 listed)
- Patient is diagnosed with ischemic pain
- Patient is diagnosed with arachnoiditis
- Patient is diagnosed with complex regional pain syndrome (CRPS I and II)
- Patient is diagnosed with peripheral vascular disease (PVD)
- Patient is diagnosed with diabetic neuropathic pain
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 |
|---|---|---|
| Burst and Tonic stimulation | Procedure or surgery | Burst and Tonic stimulation |
Primary outcome
Percentage Change From Baseline in Overall VAS at 3 Months
Time frame: 3 months
Percentage change in pain relief at the 3- month follow-up visit compared to baseline visit, as measured by the Visual Analog Scale (VAS). The VAS scale with a 10 cm (or 100 mm) line to indicate pain intensity progression with no pain (0) on the left end and worst pain (100) on the right end. Percent change is calculated as "[(post baseline baseline)/baseline] *100%" with positive numbers to represent increases and negative numbers to represent decreases.
8 secondary outcomes
Pain Relief
Time frame: 3 Months
Pain Relief
Time frame: 6 Months
Pain Relief
Time frame: 12 Months
Change in Pain Catastrophizing Scale
Time frame: 12 Months
Number of Participants With Analgesic Reduction
Time frame: 12 Months
Change in Quality of Life
Time frame: Baseline and 12 Months
Rate of Serious Adverse Events and/or Procedure/Device-related Adverse Events
Time frame: from enrollment to 12 months follow up
Paresthesia Mapping at 3 Months Compared to the Empower Study
Time frame: 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tony Van Havenbergh principal investigator
St Augustinus, Wilrijk, Belgium
Devyani Nanduri study director
Abbott Medical Devices
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Burst and Tonic stimulation in people with Chronic Pain, run by Abbott Medical Devices at 21 sites in 9 countries.
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 7 inclusion and 16 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Germany, Australia, Italy, Netherlands, United Kingdom and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change From Baseline in Overall VAS at 3 Months (time frame: 3 months). 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 8 Jul 2024.