ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

— ReActiv8-B  

Official title:

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain (ReActiv8-B)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577354
• Other study ID #: 950057
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2024

Study information

• Verified date: May 2024
• Source: Mainstay Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: January 2024
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Genesis Research Services	Broadmeadow	New South Wales
Australia	Monash Clinical Research	Clayton	Victoria
Australia	Sunshine Coast Clinical Research	Noosa Heads	Queensland
Australia	Pain Medicine of South Australia	Welland	South Australia
Belgium	AZ Nikolaas	Sint-Niklaas
Belgium	Sint Augustinus	Wilrijk
Netherlands	Erasmus MC University Medical Center	Rotterdam
United Kingdom	Seacroft Hospital	Leeds
United Kingdom	St. Bartholomew's Hospital	London
United Kingdom	The James Cook University Hospital	Middlesbrough
United States	University of Colorado Hospital	Aurora	Colorado
United States	The Brigham and Women's Hospital	Boston	Massachusetts
United States	Indiana Spine Group	Carmel	Indiana
United States	Center for Pain Relief	Charleston	West Virginia
United States	Louis Stokes VA Medical Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	OrthoIndy	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California, San Diego	La Jolla	California
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Beaumont Health	Royal Oak	Michigan
United States	The Spine Institute	Santa Monica	California
United States	Upstate Clinical Trials	Spartanburg	South Carolina
United States	Northwest Orthopaedic Specialists	Spokane	Washington
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mainstay Medical

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Supplementary Analysis of Primary Endpoint: Responder Rate of Low Back Pain With No Increase in Low Back Pain Medications	This pre-specified analysis of the primary endpoint examines the impact of rescue medications taken for acute pain conditions for reasons other than low back pain, by excluding those participants from the analysis who took rescue medications for reasons other than low back pain.; Nine participants in both groups increased pain medications. In the control group, all nine participants increased pain medications due to low back pain. In the treatment group, three of the nine participants increased pain medications due to low back pain, while six of the nine participants increased pain medications for reasons other than low back pain. Since any increase in pain medications automatically considers a participant a non-responder, these six participants are removed from this analysis to eliminate the confounding factor of increases in pain medications for reasons other than low back pain.	120 Days
Other	Treatment Satisfaction	The Treatment Satisfaction Questionnaire asking the participant if they are satisfied with the treatment.	120 Days
Other	Treatment Satisfaction at One Year	The Treatment Satisfaction Questionnaire asking the participant if they are satisfied with the outcome of the treatment.; 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.	1 Year
Other	Clinical Global Impression of Change	Clinical Global Impression consists of the following question completed by the Investigator prior to unblinding: In your opinion as a clinician, compared to the patient's situation at baseline, would you say the patient is: 1) Much better, 2) Slightly better, 3) About the same, 4) Slightly worse, 5) Much worse.	120 Days
Other	Clinical Global Impression of Change at One Year	Clinical Global Impression consists of the following question completed by the Investigator prior to unblinding: In your opinion as a clinician, compared to the patient's situation at baseline, would you say the patient is: 1) Much better, 2) Slightly better, 3) About the same, 4) Slightly worse, 5) 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.	1 Year
Other	Change in Opioid Use for Treatment of Low Back Pain at One-Year	Any increase or decrease of dosage or frequency of an opioid taken for the treatment of low back pain was considered a change.	1 Year
Primary	Responder Rate of Low Back Pain With No Increase in Pain Medications	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.	120 Days
Primary	Mean Change in Low Back Pain VAS	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.	120 Days
Primary	Cumulative Proportion of Responders Analysis (CPRA) for the Primary Endpoint to Compare Participants Responses Over a Full Range of Response Levels	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	120 Days
Primary	Serious Device and/or Procedure Related Adverse Event Rate	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.	120 Days
Secondary	Change in Oswestry Disability Index (ODI)	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.	120 Days
Secondary	Change in European Quality of Life Score on Five Dimensions (EQ-5D)	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.	120 Days
Secondary	Change in Percent Pain Relief (PPR)	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.	120 Days
Secondary	Subject Global Impression of Change (SGIC)	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	120 Days
Secondary	Resolution of Back Pain (VAS =2.5 cm)	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.	120 Days
Secondary	LBP VAS Responder Rate at One Year	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.	1 Year
Secondary	Mean Change in LBP VAS at One Year	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.	1 Year
Secondary	Change in Oswestry Disability Index (ODI) at One Year	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.	1 Year
Secondary	Change in European Quality of Life Score on Five Dimensions (EQ-5D) at One Year	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.	1 Year
Secondary	Percent Pain Relief at One Year	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.	1 Year
Secondary	Subject Global Impression of Change (SGIC) at One Year	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.	1 Year
Secondary	Resolution of Back Pain at One Year	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.	1 Year