Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01077947

Enrollment

Registered

2010-03-01

Start date

2010-02-28

Completion date

2014-02-28

Last updated

2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discogenic Pain, Low Back Pain

Keywords

low back pain, spinal fusion, Primarily axial low back pain

Brief summary

Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.

Interventions

PROCEDUREFunctional anesthetic discography

Functional anesthetic discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.

PROCEDUREProvocative Discography

Provocative Discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Age between 21 to 65 years. 2. Symptoms of at least 6 months duration. 3. Primarily axial low back pain. 4. At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc. 5. Patients with overall pain scores of greater than 6/10 (NRS). 6. Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.

Exclusion criteria

1. History of previous spine surgery. 2. MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI. 3. Clinical or radiological evidence of significant: 1. Disc herniation 2. Spinal Stenosis 3. Spinal Deformity 4. Spondylolisthesis 5. Spinal instability or pars-defect 6. Facet Syndrome 7. Sacroiliac Joint Dysfunction 8. Myofascial Pain Syndrome 9. Fibromyalgia 4. Current issues of: 1. Litigation 2. Disability 3. Drug addiction or substance abuse 4. Chronic pain medication abuse 5. Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.

Design outcomes

Primary

Measure	Time frame	Description
Pain	One Year	Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake

Secondary

Measure	Time frame	Description
Physical functioning	One Year	Oswestry Disability Index
Quality of Life	One Year	SF-36 health survey
Patient Satisfaction	One Year	Patient Global Impression of Change

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026