Low Back Pain Clinical Trial
Official title:
A Prospective Registry Study Evaluating the Safety and Efficacy of Fibrin for Chronic Multi-level Discogenic Low Back Pain
Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 30, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Recipient of Intra-annular fibrin injection for annular defects identified radographically and by annulogram Exclusion Criteria: - Scoliosis greater than 20 degrees - Spondylolysis - Spondylolisthesis greater than Grade 1 - Disc extrusion - Disc herniations or bulges > 4mm causing severe stenosis - Prior lumbar surgery or intradiscal procedure (i.e. intradiscal electrothermal therapy, nucleoplasty) - Cauda equina syndrome - Active malignancy or tumor as source of symptoms - Evidence of prior lumbar vertebral body fracture or trauma - Foraminal stenosis at the affected levels resulting in severe thecal sac compression - Dynamic instability on lumbar flexion/extension radiographs - Positive response to diagnostic medial branch block or facet joint injection or sacroiliac joint injection - Known bleeding disorder - Known or suspected hypersensitivity or allergy to drugs or components of the fibrin sealant, including aprotinin, used in the procedure - Presence of ferromagnetic implants that would interfere with MRI evaluations - Active or pending workers' compensation claims or other litigation related to the condition. - Pregnant or plans to become pregnant over the course of study participation (2 years) |
Country | Name | City | State |
---|---|---|---|
United States | Interventional Spine Specialist | Tyler | Texas |
Lead Sponsor | Collaborator |
---|---|
Pauza, Kevin, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index (ODI) | The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain. Scale for the ODI is from 0 (best) - 100 (worst). | Two Years | |
Secondary | Numeric Rating Scale (NRS) | The NRS consists of a numeric version of the visual analog scale. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. Scale for NRS is from 0 (best) - 10 (worst). | Two Years | |
Secondary | Visual Analog Scale (VAS) for back pain | When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for back pain is from 0 (best) - 10 (worst). | Two Years | |
Secondary | Visual Analog Scale (VAS) for leg pain | When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. Scale for VAS for leg pain is from 0 (best) - 10 (wors | Two Years | |
Secondary | PROMIS Physical Health | The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Physical Health is from 16.2 (worst) - 67.7 (best) | Two Years | |
Secondary | PROMIS Mental Health | The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. Scale for PROMIS Mental Health is from 21.2 (worst) - 67.6 (best). | Two Years | |
Secondary | North American Spine Society (NASS) for patient satisfaction | The North American Spine Society (NASS) developed an outcome assessment instrument to measure diverse dimensions of the impact of lumbar spine problems. Scale range is from 1 to 4 (best to worst). | Two Years | |
Secondary | EURO Quality of Life (EuroQol) | EuroQol is an instrument which evaluates the generic quality of life developed in Europe and widely used. Scale is from 0.33 (worst - 0.88 (best). | Two Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03916705 -
Thoraco-Lumbar Fascia Mobility
|
N/A | |
Completed |
NCT04007302 -
Modification of the Activity of the Prefrontal Cortex by Virtual Distraction in the Lumbago
|
N/A | |
Completed |
NCT03273114 -
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain
|
N/A | |
Recruiting |
NCT03600207 -
The Effect of Diaphragm Muscle Training on Chronic Low Back Pain
|
N/A | |
Completed |
NCT04284982 -
Periodized Resistance Training for Persistent Non-specific Low Back Pain
|
N/A | |
Recruiting |
NCT05600543 -
Evaluation of the Effect of Lumbar Belt on Spinal Mobility in Subjects With and Without Low Back Pain
|
N/A | |
Withdrawn |
NCT05410366 -
Safe Harbors in Emergency Medicine, Specific Aim 3
|
||
Completed |
NCT03673436 -
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
|
||
Completed |
NCT02546466 -
Effects of Functional Taping on Static Postural Control in Patients With Non-specific Chronic Low Back Pain
|
N/A | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05156242 -
Corticospinal and Motor Behavior Responses After Physical Therapy Intervention in Patients With Chronic Low Back Pain.
|
N/A | |
Recruiting |
NCT04673773 -
MY RELIEF- Evidence Based Information to Support People Aged 55+ Years Living and Working With Persistent Low-back Pain.
|
N/A | |
Completed |
NCT06049251 -
ELDOA Technique Versus Lumbar SNAGS With Motor Control Exercises
|
N/A | |
Completed |
NCT06049277 -
Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain
|
N/A | |
Completed |
NCT04980469 -
A Study to Explore the Effect of Vitex Negundo and Zingiber Officinale on Non-specific Chronic Low Back Pain Due to Sedentary Lifestyle
|
N/A | |
Completed |
NCT04055545 -
High Intensity Interval Training VS Moderate Intensity Continuous Training in Chronic Low Back Pain Subjects
|
N/A | |
Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
Recruiting |
NCT05552248 -
Assessment of the Safety and Performance of a Lumbar Belt
|
||
Completed |
NCT05801588 -
Participating in T'ai Chi to Reduce Back Pain and Improve Quality of Life
|
N/A | |
Completed |
NCT05811143 -
Examining the Effects of Dorsal Column Stimulation on Pain From Lumbar Spinal Stenosis Related to Epidural Lipomatosis.
|