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Trial Outcomes & Findings for Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain (NCT NCT00443781)

NCT ID: NCT00443781

Last Updated: 2021-01-05

Results Overview

For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (\>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of \>=2 Numerical Rating Scale (NRS) points AND \>33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

Approximately 2 hours per subject

Results posted on

2021-01-05

Participant Flow

Participant milestones

Participant milestones
Measure
PD and F.A.D. Diagnostic Testing
Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
Overall Study
STARTED
62
Overall Study
COMPLETED
37
Overall Study
NOT COMPLETED
25

Reasons for withdrawal

Reasons for withdrawal
Measure
PD and F.A.D. Diagnostic Testing
Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
Overall Study
Lost to Follow-up
10
Overall Study
Physician Decision
2
Overall Study
Protocol Violation
1
Overall Study
Withdrawal by Subject
6
Overall Study
Unable to comply with study follow up
2
Overall Study
Investigator terminated participation
1
Overall Study
Insurance not covered
2
Overall Study
PD/FAD not done
1

Baseline Characteristics

Study Of Disc Anaesthesia For The Preoperative Diagnosis Of Chronic Lower Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PD and F.A.D. Diagnostic Testing
n=62 Participants
Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
61 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age, Continuous
40.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male
Female
36 Participants
n=5 Participants
Sex: Female, Male
Male
26 Participants
n=5 Participants
Region of Enrollment
United States
62 participants
n=5 Participants

PRIMARY outcome

Timeframe: Approximately 2 hours per subject

Population: Subjects which underwent Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.) consist of 1 population (N=50). Subjects which underwent either PD, F.A.D. or neither diagnostic test consist of a second population (all subjects enrolled, N=62). This is a diagnostic study. No imputation technique was used.

For provocative discography (PD), a positive response at an individual disc requires all of the following findings: pain intensity (\>=7/10 on 0-10 Numerical Rating Scale, NRS) as rated by subjects on injecting contrast into a disc; concordancy (pain reproduces typical back pain exactly). For Functional Anesthetic Discography (F.A.D.), a positive test at an individual disc level is defined as improvement in self-rated pain of \>=2 Numerical Rating Scale (NRS) points AND \>33% on 0-10 Numerical Rating Scale 10 minutes after injection of lidocaine.

Outcome measures

Outcome measures
Measure
PD and F.A.D. Diagnostic Testing
n=66 discs
Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
PD - Negative and F.A.D. - Negative
18 discs
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
PD - Negative and F.A.D. - Positive
7 discs
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
PD - Positive and F.A.D. - Negative
25 discs
Difference in Number of Magnetic Resonance Imaging (MRI)-Positive Discs Diagnosed Positive by Provocative Discography (PD) and Functional Anesthetic Discography (F.A.D.)
PD - Positive and F.A.D. - Positive
16 discs

Adverse Events

PD and F.A.D. Diagnostic Testing

Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
PD and F.A.D. Diagnostic Testing
n=62 participants at risk
Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
Musculoskeletal and connective tissue disorders
neck pain
1.6%
1/62 • Number of events 1

Other adverse events

Other adverse events
Measure
PD and F.A.D. Diagnostic Testing
n=62 participants at risk
Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
Gastrointestinal disorders
nausea
3.2%
2/62 • Number of events 2
Gastrointestinal disorders
vomiting
3.2%
2/62 • Number of events 2
Injury, poisoning and procedural complications
back injury
1.6%
1/62 • Number of events 1
Injury, poisoning and procedural complications
procedural pain
1.6%
1/62 • Number of events 1
Musculoskeletal and connective tissue disorders
back pain
4.8%
3/62 • Number of events 3
Musculoskeletal and connective tissue disorders
groin pain
1.6%
1/62 • Number of events 1
Musculoskeletal and connective tissue disorders
muscle spasms
1.6%
1/62 • Number of events 1
Musculoskeletal and connective tissue disorders
pain in extremity
3.2%
2/62 • Number of events 2
Nervous system disorders
monoparesis
1.6%
1/62 • Number of events 1
Nervous system disorders
sciatica
1.6%
1/62 • Number of events 1
Nervous system disorders
syncope vasovagal
1.6%
1/62 • Number of events 1
Psychiatric disorders
abnormal dreams
1.6%
1/62 • Number of events 1

Additional Information

Clinical Department

Medtronic Spine and Biologics

Phone: 1800-876-3133

Results disclosure agreements

  • Principal investigator is a sponsor employee No publication, abstract, or presentation shall be submitted unless the multi-center report has been published. If report is not submitted within 24 months after completion, PI can present outcomes from their site. Proposed publications or presentations to be submitted to sponsor for review at least 60 days in advance. If proposed publication or presentation contains subject matter which is deemed to warrant intellectual property protection, sponsor may delay up to an additional 90 days.
  • Publication restrictions are in place

Restriction type: OTHER