Comparison of HF10 therapy combined with Conventional Medical Managment (CMM) to CMM alone in the treatment of chronic back pain

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN87648175
• Date of registration: 27/11/2017
• Prospective Registration: No
• Primary sponsor: Nevro Corp
• Public title: Comparison of HF10 therapy combined with Conventional Medical Managment (CMM) to CMM alone in the treatment of chronic back pain
• Scientific title: A multi-center, prospective, pragmatic, randomized, controlled clinical trial to compare HF10 therapy to Conventional Medical Management in the treatment of Non-Surgical Refractory Back Pain
• Date of first enrolment: 31/10/2017
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN87648175
• Study type: Interventional
• Study design: Multi-center prospective randomised study to compare the two treatment groups (Treatment)

Countries of recruitment

Austria, Germany, Netherlands, United Kingdom

Contacts

• Name: Brad Gliner

Key inclusion & exclusion criteria

Inclusion criteria:
1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component
2. Have failed conventional medical treatments
3. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
4. Demonstrating multi-level Degenerative Disc Disease and no current indication for referral for back surgery
5. Considering daily activity and rest, have average back pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
6. Average back pain intensity greater than average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
7. Be on stable pain medications, as determined by the Investigator
8. Be 18 years of age or older at the time of enrollment
9. Be willing and capable of giving informed consent
10. Be willing and able to comply with study-related requirements, procedures, and visits
11. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent

Exclusion criteria:
1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
2. Have a medical condition or pain in other area(s), not intended to be treated in this study
3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
4. Have significant clinically mechanical spine instability
5. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
6. Have an opioid addiction or drug seeking behavior as determined by the Investigator
7. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
8. Have prior experience with neuromodulation devices
9. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guideline in the Physician’s Manual
10. Have metastatic malignant disease or active local malignant disease
11. Have a life expectancy of less than 2 years
12. Have an active systemic or local infection
13. Be pregnant (participants of child-bearing potential that are sexually active must use a reliable form of birth control)
14. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
15. Be concomitantly participating in another clinical study
16. Be involved in an injury claim under current litigation
17. Have a pending or approved worker’s compensation claim


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic non-surgical refractory back pain
Injury, Occupational Diseases, Poisoning
Chronic non-surgical refractory back pain

Intervention(s)

Participants are randomly allocated in a 1:1 ratio to either the control or the intervention group:

Those in the intervention group receive the HF10 spinal cord stimulation therapy. They undergo Spinal Cord Stimulation (SCS) at 10 kHz (HF10 Therapy). 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.

The control group received the Conventional Medical Management (CMM). CMM is the standard treatment provided for chronic back pain patients if not treated with a spinal cord stimulation system – Active Comparator is HF10+CMM. Device is HF10 therapy (Senza 10kHz Spinal Cord Stimulation).

Each participant is followed for 12 months. The participants attend regular clinic visits to complete questionnaires, and to provide feedback on their pain. The treatment for both group is expected to last a total of 12 months.

Primary Outcome(s)

Responder rates is measured using the visual analog scale (VAS) (as defined by at least a 50% reduction in pain) at 3 months.

Secondary Outcome(s)

1. Successful back pain relief is measured using the visual analog scale (VAS) at 1, 3, 6, 9 and 12 months
2. Percentage of patients who experience at least 50% reduction in pain intensity is measured using the VAS at 1, 3, 6, 9 and 12 months
3. Back pain intensity is measured using VAS at baseline, 1, 3, 6, 9 and 12 months
4. Percentage of participants who experience a back pain intensity score of =2.5 cm as measured using the VAS scale at 1, 3, 6, 9 and 12 months
5. Quality of life is measured using EQ-5D questionnaire at 3, 6 and 12 months
6. Health economic outcomes are measured using clinic visits, incidence of adverse events, EQ-5D at 1, 3, 6, 9 and 12 months

Secondary ID(s)

CA2017 SENZA-NSRBP

Source(s) of Monetary Support

Nevro Corp

Ethics review

Status:
Approval date:
Contact:

North East - York Research EC, 08/08/2017, ref: 224762

Results

• Results available: Yes
• Date Completed: 31/12/2020