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SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (SMART)

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ClinicalTrials.gov Identifier: NCT01446419
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Relievant Medsystems, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Low Back Pain
Interventions Device: Intracept Treatment
Device: Sham Treatment
Enrollment 225
Recruitment Details Subjects were screened and enrolled at 15 sites in the US and 3 sites in Germany
Pre-assignment Details 2:1 Randomization (treatment: sham)
Arm/Group Title Intracept Treatment Sham Treatment
Hide Arm/Group Description Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back. Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Period Title: Overall Study
Started 147 78
3 Month Follow-up 146 77
6 Month Follow-up 144 77
12 Month Follow-up 142 77
Completed 142 77
Not Completed 5 1
Reason Not Completed
Death             1             0
Withdrawal by Subject             1             1
Terminated per protocol             3             0
Arm/Group Title Intracept Treatment Sham Treatment Total
Hide Arm/Group Description Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back. Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered. Total of all reporting groups
Overall Number of Baseline Participants 147 78 225
Hide Baseline Analysis Population Description
Intent to Treat Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 78 participants 225 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
138
  93.9%
74
  94.9%
212
  94.2%
>=65 years
9
   6.1%
4
   5.1%
13
   5.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 147 participants 78 participants 225 participants
46.9  (10.46) 47.1  (8.97) 47.0  (9.95)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 78 participants 225 participants
Female
65
  44.2%
37
  47.4%
102
  45.3%
Male
82
  55.8%
41
  52.6%
123
  54.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 78 participants 225 participants
Hispanic or Latino
9
   6.1%
5
   6.4%
14
   6.2%
Not Hispanic or Latino
138
  93.9%
73
  93.6%
211
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 78 participants 225 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   0.4%
Asian
2
   1.4%
0
   0.0%
2
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
   4.1%
2
   2.6%
8
   3.6%
White
134
  91.2%
71
  91.0%
205
  91.1%
More than one race
1
   0.7%
0
   0.0%
1
   0.4%
Unknown or Not Reported
4
   2.7%
4
   5.1%
8
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 147 participants 78 participants 225 participants
United States 133 69 202
Germany 14 9 23
Oswestry Disability Index (ODI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 147 participants 78 participants 225 participants
42.9  (10.73) 41.1  (10.39) 42.2  (10.63)
[1]
Measure Description: ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.
1.Primary Outcome
Title Change in ODI From Baseline to 3 Months Post-treatment
Hide Description

The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.

ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.

Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.
Arm/Group Title Intracept Treatment Sham Treatment
Hide Arm/Group Description:
Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Overall Number of Participants Analyzed 128 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-20.5
(-23.2 to -17.8)
-15.2
(-18.7 to -11.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intracept Treatment, Sham Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANCOVA
Comments P-value from ANCOVA with factors of tx group, analysis center and tx group by analysis center interaction, and a covariate of baseline ODI score.
2.Secondary Outcome
Title Patient Success at 3 Months
Hide Description

Proportion of subjects with clinical success at 3 months, where clinical success was defined as:

  • 3 month ODI score represented at least a 15-point reduction from baseline
  • no device or procedure related SAE between baseline and 3 mos.
  • no increase in opioid use between procedure and 3 mos.
  • no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.
  • no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.
Arm/Group Title Intracept Treatment Sham Treatment
Hide Arm/Group Description:
Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Overall Number of Participants Analyzed 128 77
Measure Type: Number
Unit of Measure: percentage of patients
55.5 45.5
3.Secondary Outcome
Title Change in ODI From Baseline to 6 Months Post-treatment
Hide Description

The improvement in ODI at 6 months compared to baseline.

ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.
Arm/Group Title Intracept Treatment Sham Treatment
Hide Arm/Group Description:
Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
Overall Number of Participants Analyzed 128 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-20.8
(-23.4 to -18.2)
-17.0
(-20.3 to -13.7)
Time Frame 12 Months
Adverse Event Reporting Description Adverse Events reported for all Intent to Treat subjects from randomization through 12 months of follow-up
 
Arm/Group Title Intracept Treatment Sham Treatment
Hide Arm/Group Description Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back. Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
All-Cause Mortality
Intracept Treatment Sham Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Intracept Treatment Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/147 (6.12%)      5/78 (6.41%)    
Infections and infestations     
Gastrointestinal bacterial infection 1 [1]  1/147 (0.68%)  1 0/78 (0.00%)  0
Injury, poisoning and procedural complications     
Airway obstruction on anaesthetic induction 1 [2]  0/147 (0.00%)  0 1/78 (1.28%)  1
Complications from lymph node excision 1 [1]  1/147 (0.68%)  1 0/78 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis aggravated 1 [1]  1/147 (0.68%)  1 0/78 (0.00%)  0
Neck pain 1 [1]  1/147 (0.68%)  1 0/78 (0.00%)  0
Low back pain 1 [1]  2/147 (1.36%)  2 0/78 (0.00%)  0
Nervous system disorders     
Grand mal seizure 1 [1]  1/147 (0.68%)  1 0/78 (0.00%)  0
CVA 1 [1]  0/147 (0.00%)  0 1/78 (1.28%)  1
Surgical and medical procedures     
C-section 1 [1]  0/147 (0.00%)  0 1/78 (1.28%)  1
Hip replacement 1 [1]  1/147 (0.68%)  1 1/78 (1.28%)  1
Bladder operation 1 [1]  1/147 (0.68%)  1 0/78 (0.00%)  0
Vascular disorders     
Deep vein thrombosis 1 [1]  0/147 (0.00%)  0 1/78 (1.28%)  1
1
Term from vocabulary, MedDRA Version 14.1
[1]
Not related to device or procedure
[2]
Procedure related
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intracept Treatment Sham Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/147 (53.06%)      24/78 (30.77%)    
Injury, poisoning and procedural complications     
Incision site discomfort  17/147 (11.56%)  17 5/78 (6.41%)  5
Post procedural nausea  15/147 (10.20%)  15 4/78 (5.13%)  4
Musculoskeletal and connective tissue disorders     
Leg pain  12/147 (8.16%)  12 4/78 (5.13%)  4
Low back pain  34/147 (23.13%)  35 11/78 (14.10%)  11
1
Term from vocabulary, MedDRA Version 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Individual PIs will not publish any study results until completion of study and publication of the multi-center results in a peer-reviewed journal, which shall occur within one year after study completion. Thereafter, PIs may publish individual site experience. Sponsor can review results communications prior to public release and can embargo communications regarding results for a period that is less than or equal to 60 days from the time submitted to sponsor for review.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: V.P. of Clinical & Regulatory Affairs
Organization: Relievant Medsystems, Inc.
Phone: 650-261-2259
EMail: lhook@relievant.com
Layout table for additonal information
Responsible Party: Relievant Medsystems, Inc.
ClinicalTrials.gov Identifier: NCT01446419    
Other Study ID Numbers: CIP 0003
First Submitted: October 3, 2011
First Posted: October 5, 2011
Results First Submitted: July 12, 2016
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016