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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02577354
Registration number
NCT02577354
Ethics application status
Date submitted
12/10/2015
Date registered
16/10/2015
Date last updated
4/06/2024
Titles & IDs
Public title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain
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Scientific title
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)
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Secondary ID [1]
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950057
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Universal Trial Number (UTN)
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Trial acronym
ReActiv8-B
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
Treatment: Devices - ReActiv8 Implantable Stimulation System (Low Stimulation)
Experimental: Treatment -
Experimental: Control -
Treatment: Devices: ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)
ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.
Treatment: Devices: ReActiv8 Implantable Stimulation System (Low Stimulation)
ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Responder Rate of Low Back Pain With No Increase in Pain Medications
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Assessment method [1]
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Comparison of responder rates for low back pain VAS between Treatment and Control groups.
The Primary Efficacy Endpoint is a comparison of responder rates between Treatment and Control groups, where a "responder" is a participant with =30% reduction from baseline in average low back pain VAS, without any increase from baseline in pain medications and/or muscle relaxants for any reason including non low back pain reasons.
The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, where zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain.
Any increase in dosage of a pain medication or any new pain medication taken for any reason counts as an increase in medications.
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Timepoint [1]
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120 Days
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Primary outcome [2]
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Mean Change in Low Back Pain VAS
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Assessment method [2]
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Comparison of change in LBP VAS (120 days from baseline) between the Treatment and Control groups. The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, where zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain.
A change to a lower score (negative value) indicates improvement.
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Timepoint [2]
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120 Days
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Primary outcome [3]
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Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels
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Assessment method [3]
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The CPRA, which was prespecified in the clinical protocol and statistical analysis plan prior to the start of the trial, was performed using the same data as used for the primary endpoint analysis and was included as part of the primary endpoint analysis
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Timepoint [3]
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120 Days
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Primary outcome [4]
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Serious Device and/or Procedure Related Adverse Event Rate
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Assessment method [4]
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The primary safety assessment is of serious device and/or procedure related adverse events in all participants at 120 days.
The 8 events reported below are 6 implant site pocket infections, 1 intra-operative upper airway obstruction, and 1 non-radicular, focal numbness on the surface of the thigh.
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Timepoint [4]
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120 Days
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Secondary outcome [1]
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Change in Oswestry Disability Index (ODI)
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Assessment method [1]
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Comparison of change in ODI (120 days from baseline) between Treatment and Control groups. ODI is reported as a score from 0 to 100%, where 0%-20% indicates minimal disability, 21%-40% indicates moderate disability, 41%-60% indicates severe disability, 61%-80% indicates crippled, and 81%-100% indicates bedbound or an exaggeration of symptoms.
A change to a lower score (negative value) indicates improvement.
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Timepoint [1]
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120 Days
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Secondary outcome [2]
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Change in European Quality of Life Score on Five Dimensions (EQ-5D)
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Assessment method [2]
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Comparison of change in EQ-5D (120 days from baseline) between Treatment and Control groups. The EQ-5D Index is scored on a scale of -0.594 to 1.00, with a score of 1.00 indicating full health.
A change to a higher score (positive value) indicates improvement.
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Timepoint [2]
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120 Days
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Secondary outcome [3]
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Change in Percent Pain Relief (PPR)
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Assessment method [3]
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PPR is a patient-reported percent of pain relief at 120 days compared to the pain at baseline, where 0% indicates no pain relief compared to baseline, and 100% indicates complete pain relief compared to baseline.
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Timepoint [3]
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120 Days
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Secondary outcome [4]
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Subject Global Impression of Change (SGIC)
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Assessment method [4]
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A questionnaire completed with the following item: Since I enrolled in the study, my overall status is 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse
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Timepoint [4]
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120 Days
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Secondary outcome [5]
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Resolution of Back Pain (VAS =2.5 cm)
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Assessment method [5]
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Resolution of back pain (remitter rate) was defined as a participant with 7-day average low back pain VAS =2.5 cm on the 10 cm VAS.
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Timepoint [5]
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120 Days
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Secondary outcome [6]
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LBP VAS Responder Rate at One Year
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Assessment method [6]
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A "responder" is a participant with =30% reduction from baseline in average low back pain VAS, without any increase from baseline in pain medications and/or muscle relaxants for any reason including non low back pain reasons.
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
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Timepoint [6]
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1 Year
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Secondary outcome [7]
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Mean Change in LBP VAS at One Year
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Assessment method [7]
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Change in LBP VAS at 1 year compared to baseline. The instrument used for evaluating pain is the continuous Visual Analog Scale (VAS) comprised of a horizontal line 10 cm in length, anchored by 2 verbal descriptors, one for each symptom extreme for Low Back Pain. Zero indicates no pain and 10 indicates worst imaginable pain. The value reported is a 7-day average low back pain.
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
A change to a lower score (negative value) indicates improvement.
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Timepoint [7]
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1 Year
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Secondary outcome [8]
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Change in Oswestry Disability Index (ODI) at One Year
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Assessment method [8]
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Change in ODI at 1 year compared to baseline. ODI is reported as a score from 0 to 100%, where 0%-20% indicates minimal disability, 21%-40% indicates moderate disability, 41%-60% indicates severe disability, 61%-80% indicates crippled, and 81%-100% indicates bedbound or an exaggeration of symptoms.
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
A change to a lower score (negative value) indicates improvement.
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Timepoint [8]
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1 Year
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Secondary outcome [9]
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Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year
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Assessment method [9]
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Change in EQ-5D at 1 year compared to baseline. The EQ-5D Index is scored on a scale of -0.594 to 1.00, with a score of 1.00 indicating full health.
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
A change to a higher score (positive value) indicates improvement.
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Timepoint [9]
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1 Year
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Secondary outcome [10]
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Percent Pain Relief at One Year
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Assessment method [10]
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PPR is a patient-reported percent of pain relief compared to the pain at baseline, where 0% indicates no pain relief compared to baseline, and 100% indicates complete pain relief compared to baseline.
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
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Timepoint [10]
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1 Year
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Secondary outcome [11]
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Subject Global Impression of Change (SGIC) at One Year
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Assessment method [11]
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A questionnaire with the following item: Since I enrolled in the study, my overall status is 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
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Timepoint [11]
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1 Year
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Secondary outcome [12]
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Resolution of Back Pain at One Year
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Assessment method [12]
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Resolution of back pain (remitter rate) was defined as a participant with 7-day average low back pain VAS =2.5 cm on the 10 cm VAS.
After the 120 day visit, participants crossed over to have their device programmed to deliver stimulation at a patient-appropriate level. At the one-year time point, participants in the Control/Crossover group have received 8 months of patient-appropriate therapy.
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Timepoint [12]
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1 Year
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Eligibility
Key inclusion criteria
1. Age =22 years, =75 years
2. Chronic Low Back Pain that has persisted >90 days prior to the baseline visit.
3. Continuing low back pain despite >90 days of medical management.
4. Qualifying pain score.
5. Qualifying disability score.
6. Evidence of lumbar multifidus muscle dysfunction.
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.
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Minimum age
22
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. BMI > 35
2. Back Pain characteristics:
1. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
2. Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of <10mm in subjects with lower extremity pain.
3. Neurological deficit possibly associated with the back pain (e.g. foot drop).
4. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
5. Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia).
6. Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
7. Back pain due to vascular causes such as aortic aneurysm and dissection.
3. Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
4. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
5. Source of pain is the sacroiliac joint as determined by the Investigator.
6. Drug use.
7. Surgical and other procedures exclusions.
8. Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion that is amenable to surgery.
9. Planned surgery.
10. Co-morbid chronic pain conditions.
11. Other clinical conditions.
12. Psycho-social exclusions.
13. Protocol compliance exclusions.
14. General exclusions.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2024
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Sample size
Target
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Accrual to date
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Final
204
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Genesis Research Services - Broadmeadow
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Recruitment hospital [2]
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Sunshine Coast Clinical Research - Noosa Heads
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Recruitment hospital [3]
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Pain Medicine of South Australia - Welland
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Recruitment hospital [4]
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Monash Clinical Research - Clayton
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Recruitment postcode(s) [1]
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- Broadmeadow
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Recruitment postcode(s) [2]
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- Noosa Heads
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Recruitment postcode(s) [3]
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- Welland
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Indiana
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Kansas
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Massachusetts
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United States of America
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Michigan
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North Carolina
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Ohio
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Rhode Island
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South Carolina
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Washington
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West Virginia
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Belgium
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Sint-Niklaas
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Belgium
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Wilrijk
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Netherlands
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Rotterdam
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Middlesbrough
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mainstay Medical
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.
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Trial website
https://clinicaltrials.gov/study/NCT02577354
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Trial related presentations / publications
Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Sayed D, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Schwab F, Maislin G, Heemels JP, Eldabe S. Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction. Neuromodulation. 2023 Jan;26(1):98-108. doi: 10.1016/j.neurom.2022.08.457. Epub 2022 Sep 27. Erratum In: Neuromodulation. 2023 Aug;26(6):1272-1273. doi: 10.1016/j.neurom.2023.03.004. Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Maislin G, Heemels JP, Eldabe S; ReActiv8-B Investigators. Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial. Neuromodulation. 2023 Jan;26(1):87-97. doi: 10.1016/j.neurom.2021.10.011. Epub 2021 Dec 18. Gilligan C, Volschenk W, Russo M, Green M, Gilmore C, Mehta V, Deckers K, De Smedt K, Latif U, Georgius P, Gentile J, Mitchell B, Langhorst M, Huygen F, Baranidharan G, Patel V, Mironer E, Ross E, Carayannopoulos A, Hayek S, Gulve A, Van Buyten JP, Tohmeh A, Fischgrund J, Lad S, Ahadian F, Deer T, Klemme W, Rauck R, Rathmell J, Levy R, Heemels JP, Eldabe S; ReActiv8-B investigators. An implantable restorative-neurostimulator for refractory mechanical chronic low back pain: a randomized sham-controlled clinical trial. Pain. 2021 Oct 1;162(10):2486-2498. doi: 10.1097/j.pain.0000000000002258.
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Public notes
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Contacts
Principal investigator
Name
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Chris Gilligan, MD, MBA
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Address
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Brigham and Women's Hospital
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/54/NCT02577354/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/54/NCT02577354/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02577354
Download to PDF