The effect of HF10™ Therapy on opioid analgesic use for the treatment of chronic intractable low back and/or radicular leg pain
| ISRCTN | ISRCTN11735894 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11735894 |
| Secondary identifying numbers | CA2018AU OR |
- Submission date
- 17/09/2018
- Registration date
- 16/10/2018
- Last edited
- 17/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims:
Long-term opioid use is common in people with chronic pain. This can lead to immune suppression, endocrine suppression, reduced libido, and an overall detrimental effect on the quality of life. These side effects have pushed the need for more appropriate pain management options, such as spinal cord stimulation (SCS). SCS involves implanting a device that delivers small electrical fields to the spinal cord to provide pain relief in patients with chronic (long-term), intractable (hard to control) back and leg pain. Significant leg pain relief has been reported with traditional SCS which uses a low frequency (<1200 Hz), but there is limited long-term data supporting the use of low frequency SCS in predominant back pain patients. Recent studies testing SCS using a frequency of 10 kHz (HF10 Therapy™) have shown that this treatment is effective and safe in patients with both back and leg pain. The results from these studies demonstrated that these patients had significant pain relief up to 24 months. The decreased pain in both back and leg were consistent throughout the studies with improvements in functional capacity with no perception of paresthesia (a burning or prickling sensation). This study will investigate the effect of HF10 Therapy on opioid analgesic pain management in a low back pain and/or leg pain population.
Who can participate?
Adults with chronic intractable low back and/or radicular leg pain
What does the study involve?
Participants undergo Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy) as per the center’s usual practice. SCS involves the surgical placement of two leads (which look like very thin wires) into a small area near the spinal cord. Electrical stimulation is delivered through these wires by a small, battery-operated, rechargeable SCS implanted generator. Each patient is followed for 12 months after device activation. Following device activation, participants will consult with their doctor to actively work towards reducing their pain medications during the 12 month follow up period. The participants attend regular clinic visits to complete questionnaires, and to provide feedback on their pain. Successfully treated participants get a permanent device implanted as per center’s routine clinical practice.
What are the possible benefits and risks of participating?
Participants may benefit from the SCS system to relieve their pain. There are no direct risks of taking part in this study, although the general risks of having a spinal stimulation device in place apply.
Where is the study run from?
7 pain centers across Australia
When is the study starting and how long is it expected to run for?
January 2018 to December 2022
Who is funding the study?
Nevro Corp (USA)
Who is the main contact?
Mr Wim Laloo
laloo@nevro.com
Contact information
Scientific
1800 Bridge Parkway
Redwood City
CA94065
United States of America
Public
Nevro Corp
1800 Bridge Parkway
Redwood City
CA94065
Belgium
Study information
| Study design | Observational prospective multi-centre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A Prospective Post-market Study to Investigate the Effect of HF10™ Therapy on Opioid Analgesic Use for the Treatment of Chronic Intractable Low Back and/or Radicular Leg Pain |
| Study objectives | To investigate the effect of HF10 Therapy on opioid analgesic pain management in chronic intractable low back and/or radicular leg pain population. |
| Ethics approval(s) | Bellberry Limited, 17/09/2018, ref 2018-08-633 |
| Health condition(s) or problem(s) studied | Chronic intractable low back and/or radicular leg pain |
| Intervention | As part of their standard care, participants undergo a trial (temporary evaluation period) of Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy) as per the centre’s usual practice and following this, those for whom the trial treatment was successful have a permanent device implanted as per center’s routine clinical practice. Following device activation, participants are followed for a period of 12 months. Following device activation, participants will consult with their doctor to actively work towards reducing their pain medications during the 12 month follow up period. The participants attend regular clinic visits, at 1, 3, 6, 9 and 12 months, to complete questionnaires, and to provide feedback on their pain, quality of life, disability, health status, satisfaction and sleep. At these visits, the physicians will take assessments from the participants such as pain evaluation, medication usage and side effects (if any). |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The proportion of subjects who report clinical success with HF10 therapy at the 6-month study visit. Clinical success is denoted by any of the following criteria described on the Opioid Use and Pain Outcome Matrix: 1. Decreased opioids (≥30%) 2. Decrease in predominant pain (≥30%) |
| Secondary outcome measures | The following will be successively evaluated (hierarchical test approach) in the order shown with a 0.05 significance until statistical significance is not achieved: 1. Proportion of subjects who respond to HF10 therapy, assessed at the baseline and after 6 months by a ≥50% improvement in low back pain or leg pain visual analogue scale (VAS) from the baseline at 6 months 2. Proportion of subjects reporting at least a 30% reduction from baseline in opioid analgesic use as measured by the morphine equivalent daily dose (MEDD) at 6 months 3. Proportion of subjects who respond to HF10 therapy, assessed at the baseline and after 12 months by a ≥50% improvement in low back pain or leg pain VAS from the baseline at 12 months 4. Proportion of subjects reporting at least a 30% reduction from baseline in opioid analgesic use as measured by the morphine equivalent daily dose (MEDD) at 12 months 5. Proportion of subjects that experience at least a 10-point reduction in the Oswestry Disability Index at 12 months 6. Proportion of patients reporting ≥0.100 improvement from the baseline in quality of life, assessed using the EQ-5D-5L at 12 months |
| Overall study start date | 07/01/2018 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 49 study participants with a permanent device implant will be evaluated |
| Key inclusion criteria | 1. Diagnosed with chronic intractable back and/or leg pain 2. 18 years of age or older at time of enrolment 3. Currently taking opioids within a dose range of 15-100 mg/day oral morphine or the equivalent (MEDD) 4. Average back or leg pain intensity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrolment 5. Meet the requirements for being an HF10 Therapy trial candidate as per the centers’ practice, which includes psychological evaluation 6. Willing and able to complete health questionnaires and pain scales as specified in the protocol |
| Key exclusion criteria | 1. Plans to enrol in another clinical study during their participation in this study, or are currently enrolled in an interventional clinical study that could interfere in participation in this study or affect the scientific soundness of this study 2. Medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis or fibromyalgia) 3. Current addiction to cocaine, opiates, alcohol, or benzodiazepines as determined by the treating physician 4. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by either the treating physician or a psychologist 5. Current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, and/or central deafferentation syndrome 6. Current diagnosis of a coagulation disorder, bleeding diathesis that would put subject at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease, or uncontrolled diabetes mellitus 7. Diagnosis of scoliosis that precludes lead placement 8. Condition currently requiring or likely to require the use of diathermy 9. Metastatic malignant disease or active local malignant disease 10. Life expectancy of less than 1 year 11. Active systemic or local infection 12. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal) |
| Date of first enrolment | 31/12/2018 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Australia
Study participating centres
Charlestown
NSW 2290
Australia
Evan Thomson Building
Chasely Street
AUCHENFLOWER
QLD 4066
Australia
Building 8, Level 1
Off Palmer Street Garran
Woden
ACT 2606
Australia
Kew
VIC 3101
Australia
Sponsor information
Industry
1800 Bridge Parkway
Redwood City
CA94065
United States of America
| Website | http://www.nevro.com |
|---|---|
"ROR" |
https://ror.org/02xcxe208 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned presentation of results to international congresses from the start of 2020 2. Planned publication in a peer-reviewed journal from the end of 2020 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Adele Barnard |
Editorial Notes
17/12/2019: The public contact has been changed.
24/10/2018: Internal review.
