Back PainNCT02514590
Wireless Spinal Cord Stimulation for Chronic Pain
A study testing Freedom SCS System in people with Back Pain, run by Curonix LLC at 7 sites in United States.
Trial summary
The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Freedom SCS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2016to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age at time of informed consent;
- Subjects have been diagnosed with chronic back or back and leg pain with an average VAS > 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary;
- Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
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- Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
- Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- Subject is male or non-pregnant female;
- Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
- Subject is capable of giving informed consent;
- Subject lives within reasonable distance from the study site (circumference of 50 miles).
Who cannot join
- Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
- Unresolved Malignancies in last six months;
- Subject has post-herpetic neuralgia (shingles);
- Subject has an active systemic infection or is immune-compromised;
- Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
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- Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
- Bleeding complications or coagulopathy issues;
- Pregnant/lactating or not using adequate birth control;
- A life expectancy of less than one year;
- Any active implanted device whether turned off or on;
- A previous SCS experience;
- Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Nuvo Spine and Sports Institute & Ortho Regenerative Center
Beverly Hills, California, 90212
Cleveland Clinic
Cleveland, Ohio, 44195
USC Spine Center, Keck Hospital of USC
Los Angeles, California, 90033
Compass Research
Orlando, Florida, 32806
Anesthesia Pain Care Consultants
Tamarac, Florida, 33301
Precision Spine Care
Tyler, Texas, 75701
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain
The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain
Read the detailed description
This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted.
Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system.
Stimulators will be placed at the following sites to target the painful area:
- Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.
- Conditions
- Back Pain
- Being tested
- Freedom SCS System
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom SCS SystemDevice
This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy.
| Study group | Role | What they receive |
|---|---|---|
| Freedom SCS System - 1500 HZ | Experimental | Epidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area. Receives: Device: Freedom SCS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
A 50% reduction in VAS scores when compared to baseline.
Measured: 6 Months
Secondary outcomes (9)
Percentage change in VAS Back from baseline
The percentage reduction in VAS back pain
Measured: 6 Months
Percentage change in VAS Leg from baseline
The percentage reduction in VAS leg pain
Measured: 6 Months
Oswestry Disability Index (ODI) Score
The change from baseline in functionality using the ODI
Measured: 6 Months
Patient Satisfaction
The change in satisfaction as measured by Patient Global Impression of Change
Measured: 6 Months
Disability Score
The change in European Quality of Life 5 Dimension
Measured: 6 Months
Sleep Quality
Frequency of sleep disturbances reported from diary
Measured: 6 Months
Procedure time
The time measured to implant the device from operative notes
Measured: 7 Days post implant
Opioid Reduction
The reduction in opioids as reported by patient prescription
Measured: 6 Months
Adverse Events
The incidence of device related adverse events
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2016
- Primary completionJan 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curonix LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, The Center for Clinical Research, Winston-Salem, NC, Anesthesia Pain Care Consultants, Tamarac, FL, USA, Precision Spine Care, Tyler, TX, USA, Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA, Compass Research LLC, Orlando, FL, USA, USC Spine, Keck hospital of USC, Los Angeles, CA, USA
- Responsible party
- Sponsor
- Investigators
- Nagy Mekhail, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514590
- Sponsor's protocol ID
- 30-00113
- Status last verified
- Oct 2021
- First submitted
- 31 Jul 2015
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT02514590
- Acronym / sponsor ID
- 30-00113
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Curonix LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic, The Center for Clinical Research, Winston-Salem, NC, Anesthesia Pain Care Consultants, Tamarac, FL, USA, Precision Spine Care, Tyler, TX, USA, Nuvo Spine and Sports Institute & Ortho Regenerative Center, Encino, CA, USA, Compass Research LLC, Orlando, FL, USA, USC Spine, Keck hospital of USC, Los Angeles, CA, USA
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 3 Aug 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.
The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain
Detailed description
This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted.
Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system.
Stimulators will be placed at the following sites to target the painful area:
- Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freedom SCS System - 1500 HZ | Experimental | Device: Freedom SCS SystemEpidural Space covering vertebrae level T8-T11 determined by paresthesia mapping for painful area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject is ≥ 18 years of age at time of informed consent;
- Subjects have been diagnosed with chronic back or back and leg pain with an average VAS > 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary;
- Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
Key exclusion criteria (13 listed)
- Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
- Unresolved Malignancies in last six months;
- Subject has post-herpetic neuralgia (shingles);
- Subject has an active systemic infection or is immune-compromised;
- Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
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 |
|---|---|---|
| Freedom SCS SystemThis Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy. | Device | Freedom SCS System - 1500 HZ |
Primary outcome
Pain Score
Time frame: 6 Months
A 50% reduction in VAS scores when compared to baseline.
9 secondary outcomes
Percentage change in VAS Back from baseline
Time frame: 6 Months
Percentage change in VAS Leg from baseline
Time frame: 6 Months
Oswestry Disability Index (ODI) Score
Time frame: 6 Months
Patient Satisfaction
Time frame: 6 Months
Disability Score
Time frame: 6 Months
Sleep Quality
Time frame: 6 Months
Procedure time
Time frame: 7 Days post implant
Opioid Reduction
Time frame: 6 Months
Adverse Events
Time frame: 6 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 6 Oct 2021.
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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.
Nagy Mekhail principal investigator
The Cleveland Clinic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom SCS System in people with Back Pain, run by Curonix LLC at 7 sites in United States.
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 12 inclusion and 13 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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: 6 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 6 Oct 2021.