To evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in conjunction with medical management.
ID
Source
Brief title
Condition
- Muscle disorders
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Primary Efficacy Endpoint is a comparison of responder rates between
Treatment and Control groups, where a *responder* is a Subject with >=30%
reduction from baseline in average low back pain without any increase in pain
medication and/or muscle relaxants prescribed and taken in the two weeks prior
to the primary outcome assessment visit.
The primary safety assessment is serious device and/or procedure related
adverse events in all subjects in the Intent to Treat Cohort at the primary
Endpoint Assessment visit.
Secondary outcome
The secondary efficacy objectives:
1. Comparison of change in ODI between Treatment and Control groups at the
Primary End Point Assessment Visit.
2. Comparison of change in EQ-5D between Treatment and Control groups at the
Primary End Point Assessment Visit
3. Comparison of Percent Pain Relief between Treatment and Control groups
reported by the Subject at the Primary End Point Assessment Visit
4. Comparison of Subject Global Impression of Change at the Primary End Point
Assessment Visit
5. Comparison of number of subjects with Resolution of Low Back Pain (remitters
or cure) at the Primary End Point Assessment Visit
6. Evaluation of changes in primary and secondary efficacy metrics in Crossover
Group following the Outcome Post Crossover visit.
Background summary
Chronic low back pain is a major health problem, and the World Health
Organization reports that *Low back pain is the most prevalent of
musculoskeletal conditions; it affects nearly everyone at some point in time
and about 4-33% of the population at any given point and back pain is the
number one cause of years lived with disability worldwide in 2013".
Although there has been a lot of attention and investment applied to surgical
treatments for low back pain, only approximately 20% of patients are suitable
surgical candidates. Exercise therapy is frequently prescribed for low back
pain, but the effectiveness of exercise therapy for acute back pain is
negligible. Many non-invasive conservative therapies have been tried with
modest or no success.
Published studies show that subject initiated contraction of the lumbar
multifidus with ultrasound guided biofeedback motor control physical therapy
exercises can lead to improvements in back pain, but this approach has not been
adopted due to practical challenges, economic difficulties, and patient
compliance issues. The mechanism of action is believed to be restoration of
motor control of the lumbar multifidus, thereby leading to rehabilitation of
the muscle, improved spine stability and reduction in back pain.
The ReActiv8 has been designed to incorporate the principles of these prior
approaches. Bilateral electrical stimulation of the medial branch of the dorsal
ramus nerve that innervates the lumbar multifidus is delivered episodically (10
seconds *on* followed by 20 seconds *off*, for 30 minutes, during two sessions
per day). Previous experience with the therapy in the European Feasibility
Study showed that most subjects can perceive the muscle contractions, and
report the muscle contractions as *soothing* or *pleasurable.*
In subjects with chronic low back pain and no prior surgery and with
unsatisfactory pain relief despite medical management, episodic electrical
stimulation of the medial branch of the dorsal ramus nerves to cause
contraction of the lumbar multifidus muscles can lead to relief of low back
pain and the disabling effects of back pain. ReActiv8 is an adjunct to medical
management in adults with Chronic Low Back Pain for relief of pain in subjects
who have failed at least medical management and physical therapy.
Study objective
To evaluate the safety and efficacy of ReActiv8 for the treatment of adults
with Chronic Low Back Pain and no prior spine surgery when used in conjunction
with medical management.
Study design
International, multi-center, prospective, randomized, sham controlled, blinded
trial with an adaptive statistical design.
Subjects are blinded, investigators are blinded, and the assessment of primary
end point data is blinded.
Intervention
All subjects who satisfy the baseline criteria are implanted with the ReActiv8,
and then at the randomization visit post-implant surgery are instructed to
deliver stimulation during two 30-minute sessions (morning and evening) per
day. Subjects are randomized (1:1) to the treatment or control arm at the
randomization visit post-implant.
Subjects randomized to the treatment arm of the study will have ReActiv8
programmed to deliver stimulation at a subject-appropriate level (the Treatment
group). Determination of the subject appropriate level is described in the
Implant and Programming Manual. Subjects in the Treatment group may or may not
feel muscle contraction during stimulation.
Subjects randomized to the control arm will have ReActiv8 programmed to deliver
minimal stimulation (the Control group). Subjects in the Control group may or
may not feel muscle contraction during stimulation.
After collection of all endpoint data, all Subjects in the Control group will
have the ReActiv8 IPG programmed to deliver subject appropriate stimulation to
cause strong smooth contraction of the multifidus.
Surgical implantation is adapted from familiar techniques used for medial
branch rhizotomy and spinal cord stimulation.
The implant procedure should take place as soon as possible following the
verification of baseline criteria, at a minimum of 1 day and maximum of 45 days
following Visit 1.
Study burden and risks
The purpose of electrical stimulation of the medial branch of the dorsal ramus
nerve with the ReActiv8 is to help restore neural drive to the lumbar
multifidus muscle (LM). There are known clinical benefits to the restoration of
neural drive to and rehabilitation of the LM when delivered by guided physical
therapy with image guided biofeedback including:
• Improvements in the disabling effect of low back pain
• Improvements in severity of low back pain
• Reduction in recurrence of low back pain
• Improvement in ability to handle regular daily activities, including return
to work
• Improvements in Quality of Life
Based on the Feasibility Study performed with other devices, there are expected
benefits from the stimulation to be delivered by the ReActiv8, including
decrease in low back pain, decrease in disability, and improvements in quality
of life.
There may be no benefits to the Subject as a result of participation in this
trial.
All medical device treatments have the potential to cause adverse events or
side effects. Adverse events are expected to be similar to other
neurostimulation devices for treatment of back pain.
Risks can be minimized through the use of strict compliance with the study
protocol, and adherence to the guidelines for subject selection, site training,
and close monitoring of the Subject*s physiologic status at follow-up visits.
Please refer to section E9 or the study protocol for a complete overview of
potential risks.
Please refer to section E4 for an overview of all required study assessments
which might mean an additional burden for the study patients.
Shingle Creek Parkway 6601
Brooklyn Center MN 55430
US
Shingle Creek Parkway 6601
Brooklyn Center MN 55430
US
Listed location countries
Age
Inclusion criteria
1. Age >=22 years, <=65 years
2. 7 day recall of Average Low Back Pain (VAS of >=6.0cm and <=9.0cm at baseline)
3. Oswestry Disability Index score >=21% and <=60% at the Baseline Visit.
4. Chronic Low Back Pain defined as pain and discomfort localized below the costal margin
and above the inferior gluteal fold (with or without referred leg pain) that has persisted >90
days prior to the baseline visit, which has resulted in pain in at least half of the days in the 12 months prior to the baseline visit.
5. Evidence of lumbar multifidus muscle dysfunction by the Prone Instability Test (PIT).
6. Continuing low back pain despite >90 days medical management including:
a. At least one attempt of physical therapy treatment
b. For Subjects with medications prescribed and used for chronic low back pain, usage
shall be at a stable dose in the 30 days prior to the baseline visit
7. Be willing and capable of giving Informed Consent
8. Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.
9. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.
Exclusion criteria
1. BMI > 35
2. Back Pain characteristics:
a. Any surgical correction procedure for scoliosis, or a current clinical
diagnosis of moderate to severe scoliosis.
b. Lumbar spine stenosis,
c. Neurological deficit possibly associated with the back pain.
d. Back pain due to pelvic or visceral reasons or infection.
e. Back pain due to inflammation or damage to the spinal cord or adjacent structures
f. Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amendable to surgery.
g. Back pain due to vascular causes such as aortic aneurysm and dissection.
3. Leg pain described as being worse than back pain, or radiculopathy below the knee.
4. Source of pain is the sacroiliac joint.
5. Certain surgical or other procedures exclusions (please refer to the protocol):
6. Planned surgery:
7. Pregnant or planning to be pregnant in the next 12 months.
8. Any other active implantable device
9. Prior exposure to an implantable neurostimulator for treatment of pain
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02577354 |
| CCMO | NL55826.078.16 |