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Spinal Cord Stimulation Frequency Study

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ClinicalTrials.gov Identifier: NCT01750229
Recruitment Status : Completed
First Posted : December 17, 2012
Results First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Failed Back Surgery Syndrome
Interventions Device: Sham
Device: 1200 Hz
Device: 3030 Hz
Device: 5882 Hz
Enrollment 53
Recruitment Details A total of 53 subjects were recruited between January 2013 and April 2015.
Pre-assignment Details A total of 23 subjects discontinued prior to randomization due to eligibility criteria not met or withdrawal from the study.
Arm/Group Title All Randomized Subjects
Hide Arm/Group Description Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
Period Title: Randomized Crossover Phase
Started 30
Subject Received Sham 24
Subjects Received 1200 Hz 24
Subjects Received 3030 Hz 24
Subjects Received 5882 Hz 24
Protocol Violation 4
Completed 28
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Period Title: Long-term Follow-up Phase
Started 28 [1]
Completed 25
Not Completed 3
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
[1]
Four subjects who had protocol violations continued to be followed in long-term follow-up phase.
Arm/Group Title Randomized Phase Subjects
Hide Arm/Group Description Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
47.9  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
8
  33.3%
Male
16
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 24 participants
24
Baseline VAS back pain score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 24 participants
7.75  (1.13)
[1]
Measure Description: Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from 7 days in the diary were used for summary.
1.Primary Outcome
Title Visual Analog Scale (VAS) on Back Pain
Hide Description Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population, subjects who followed the protocol and provided data for all four randomized crossover period were included in the analysis.
Arm/Group Title Sham 1200 Hz 3030 Hz 5882 Hz
Hide Arm/Group Description:
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
Overall Number of Participants Analyzed 24 24 24 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.83  (2.45) 4.51  (1.87) 4.57  (2.09) 3.22  (1.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham, 1200 Hz, 3030 Hz, 5882 Hz
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments Variables included in the Mixed Model were: baseline VAS back pain score, treatment group, and period.
Time Frame Randomized crossover phase of 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham 1200 Hz 3030 Hz 5882 Hz
Hide Arm/Group Description Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order. Randomized phase subjects received all four frequency settings (Sham, 1200 Hz, 3030 Hz, and 5882 Hz), each for 3 weeks, in a randomized order.
All-Cause Mortality
Sham 1200 Hz 3030 Hz 5882 Hz
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)      0/24 (0.00%)    
Hide Serious Adverse Events
Sham 1200 Hz 3030 Hz 5882 Hz
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      1/24 (4.17%)      0/24 (0.00%)      1/24 (4.17%)    
General disorders         
Implant site pain  1  0/24 (0.00%)  0 1/24 (4.17%)  1 0/24 (0.00%)  0 0/24 (0.00%)  0
Injury, poisoning and procedural complications         
Meniscus injury  1  0/24 (0.00%)  0 0/24 (0.00%)  0 0/24 (0.00%)  0 1/24 (4.17%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sham 1200 Hz 3030 Hz 5882 Hz
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      2/24 (8.33%)      0/24 (0.00%)    
General disorders         
Implant site pain  1  0/24 (0.00%)  0 0/24 (0.00%)  0 2/24 (8.33%)  2 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
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.

The Trust and/or the PI may prepare the data derived from the study for publication. Data will be submitted to the Sponsor for review and comment prior to publication and at least sixty (60) days prior to submission for publication, public dissemination, or review by a publication committee.

All reasonable comments made by the Sponsor in relation to a proposed publication will be incorporated by the Trust and/or the Investigator into the publication.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Neuro Clinical Trials
Organization: Medtronic Neuromodulation
EMail: medtronicneurotrials@medtronic.com
Layout table for additonal information
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01750229    
Other Study ID Numbers: 1668
First Submitted: November 19, 2012
First Posted: December 17, 2012
Results First Submitted: March 16, 2017
Results First Posted: December 18, 2017
Last Update Posted: December 18, 2017