Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT00220948 |
| Other study ID # |
P699 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 13, 2005 |
| Last updated |
September 13, 2005 |
| Start date |
August 2004 |
| Est. completion date |
March 2006 |
Study information
| Verified date |
July 2005 |
| Source |
Texas Back Institute |
| Contact |
John J Triano, DC,PhD |
| Phone |
972-644-4356 |
| Email |
jaytriano[@]msn.com |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
Hypothesis:
Myoelectric patterns observed from the CERSR array during standardized testing are sensitive
in identifying healthy subjects from patients with internal disc derangement and a positive
discogram. A positive CT discogram is defined as one following the Dallas discogram protocol
with abnormal disc morphology and reproduction of symptoms
Description:
Methodology:Patient Inclusion / Exclusion Criteria:Patient’s who present with non-radicular
low back with or without sclerotomal, referred leg pain and who have failed conservative
care for 5 months or otherwise meet clinical criteria for performing diagnostic discography
are potential candidates for recruitment in this study. The criteria are as
follows:Inclusion / Exclusion:· Age 21 – 55· No prior spine surgery.· No neurological
deficit.· VAS > 3.0· The patient has been referred for provocative discogram diagnostic
study with a suspected single level internal disc derangement.· Normal psychometric
screening.For healthy control subjects the criteria will be as follows:· Age 21 – 55· No
spinal deformity· No prior spine surgery.· No history of disabling back or leg pain.· No
history of back pain for the past 6 months year. Patient Recruitment: A total of 80
subjects, divided into four groups ( 20 per group), are being sought for this study. Group C
will be a population of healthy control subjects to be compared with Group U, unhealthy
subjects. Group U will represent the first 20 patient participants who are referred for
discogram procedures. Group DP will consist of a separate group of 20 patients being
referred for discogram testing whose results are positive. Group DN will consist of 20
patients whose discogram results are negative. Statistical criteria for valid analysis
requires separate non-overlapping grouping of patients to maintain the accuracy of the Type
1 error estimate in the analysis of results. A total of 80 patients will be sought as the
analysis of sensitivity and specificity requires a minimum number of false positive and
false negative results to be present in each subgroup for the analysis to be performed. The
TBI practice is equipped with electronic scheduling, medical record and billing systems.
This poses significant advantages for patient recruitment to this project. On a daily basis,
the Project Coordinator (PC) can access daily schedules for patients entering the system for
all 17 TBI physicians. This can be cross-correlated later with exiting diagnosis and
diagnostic orders to ensure maximum capture of potential candidates.The attending
physician’s medical assistant, on being notified of the need for a discogram, will contact
the PC. The PC then will review the chart and confer with the attending provider to confirm
entrance requirements. The patient will be asked for permission to be contacted by the PC
for soliciting participation in the project. Upon obtaining permission, the PC will contact
the patient and explain the project and signed informed consent obtained from those who
agree to participate. Those whom do not sign consent to participate or consent to be
monitored will continue with their care and be purged from the project records. Patients
will then be scheduled for CERSR evaluation prior to performance of the diagnostic
procedure. The PC will perform the CERSR test at the designated appointment and will provide
the Principal Investigator (PI) with the test results for interpretation without
identification of which diagnostic procedure or group assignment the patient is in. To
ensure blinding of the PI, the demographic fields usually maintained in the CERSR software
will be left blank with the exception of the patient identifier. Separate records will be
maintained by the PC with respect to this information as well as report of findings from
discogram as may be appropriates.The surgeon co-investigator will review the discogram
results on each patient and partition them into positive and negative results based both on
morphologic and pain concordance criteria. Testing will continue until a full block of 20
subjects for each group is obtained. The PC will also solicit healthy subjects from the TBI
and Presbyterian Hospital staffs numbering several hundred in total. All healthy volunteers
will be compensated $50.00 for their time and inconvenience in participation in the CERSR
test. Psychometric Screening: Psychometric screening of all participants (healthy and
patient) will be performed using the SCL90-R. This instrument has been used successfully for
years as a strong psychometric screening tool that incorporates evaluation for somatization.
Our consulting psychologist, Dr. Block, whose sole practice for 15 years has been the
evaluation and treatment of spine pain patients, will perform the scoring of the SCL90-R.
Subjects whose scores are high on the somatization scale alone or whose total scores are
suggestive of strong psychosocial component will not be included.CERSR Evaluation and
Interpretation:The CERSR evaluation will consist of the standardized tests for upright
standing, flexion and weight bearing. Interpretation will similarly follow the proscribed
method considering the maximum RMS, uniformity, centrality, organization and location as
described in the Appendix I. Outcome of the analysis will the classification of the patient
into disc, healthy or other.. Interpreter blinding:The PI will perform interpretation of the
CERSR tests without knowledge of the patient’s group membership. The surgeon co-investigator
will assess discogram results without knowledge of the CERSR test results. At the end of the
study, PI interpretation will be joined with the database on subject status and patient
outcome from diagnostic testing, as appropriate. Analysis will be performed with patients
grouped according to their group status (C, U, DP, DN).Interpretation of Diagnostic
Testing:A positive discogram will be determined following the Dallas protocol for abnormal
morphology within the inner disc and the reproduction of exact pain or similar pain with
disc pressurization.AnalysisAnalysis 1: Healthy (n=20) Unhealthy (n=20) Abormal CERSR False
Positive Positive Normal CERSR Negative False Negative Analysis 2: Disco Positive(n = 20)
Disco Negative(n = 20) Abnormal CERSR Positive False Positive Normal CERSR False Negative
Negative Using the proprietary CERSR methods of analysis (max RMS, uniformity, centrality,
organization) to classify patients into healthy, disc or other. Sensitivity, specificity and
predictive values will be calculated for patients who are healthy versus those who have
positive and negative CERSR tests. This analysis will establish the minimum boundaries of
the CERSR technology and its ability to differentiate normal from unhealthy subjects as well
as establish the generalizability of interpretation in the hands of this investigative
group. A healthy subject whose CERSR test is identified as having characteristics of
unhealthy patients will be classified as a false positive. Patients with suspected
discogenic pain who fail to be classified by myoelectric patterns as unhealthy will be
identified as having false negative tests. The second analysis will examine sensitivity,
specificity and predictive values for differentiating discogenic pain generators from
non-discogenic pain generators. Patients with positive CERSR tests for disc patterns of pain
who are classified by discogram as being negative will be considered false positives.
Patients with negative CERSR tests who are classified by discogram as being positive for
discogenic pain will be considered false negatives. This test will distinguish the accuracy
of pattern in separating discogenic pain from nondiscogenic sources.
