Covid 19 Research using Clinical Trials (Home Page)
Report for D013122: Spinal Diseases NIH
(Synonyms: Spinal Di, Spinal Dis, Spinal Diseases)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3225 | chronic pain team Wiki | 0.71 |
| drug915 | Dornase Alfa Wiki | 0.71 |
| drug3220 | chiropractic team Wiki | 0.71 |
| drug1582 | Local Bone Autograft Wiki | 0.71 |
| drug3094 | ViviGen® Cellular Bone Matrix Wiki | 0.71 |
Correlated MeSH Terms (5)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013168 | Spondylolisthesis NIH | 0.71 |
| D013130 | Spinal Stenosis NIH | 0.71 |
| D011843 | Radiculopathy NIH | 0.71 |
| D055959 | Intervertebral Disc Degeneration NIH | 0.50 |
| D059350 | Chronic Pain NIH | 0.25 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003302 | Spondylolisthesis HPO | 0.71 |
| HP:0008419 | Intervertebral disc degeneration HPO | 0.50 |
| HP:0012532 | Chronic pain HPO | 0.25 |
There are 2 clinical trials
Clinical Trials
1 Clinical Outcomes Associated With the Use of ViviGen® in Conjunction With Posterolateral Fusion for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.
NCT03733626 Lumbar Spondylolisthesis Degenerative Disc Disease Degenerative Spondylolisthesis Lumbar Radiculopathy Lumbar Spinal Stenosis Lumbar Disc Disease Combination Product: ViviGen® Cellular Bone Matrix Combination Product: Local Bone Autograft MeSH:Spinal Stenosis Spinal Diseases Intervertebral Disc Degeneration Spondylolisthesis Radiculopathy
HPO:Intervertebral disc degeneration Spondylolisthesis
Primary Outcomes
Description: Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Measure: Incidence of successful Lumbar Fusion measured radiographically Time: 12 months postoperative
Secondary Outcomes
Description: Equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months.
Measure: Visual Analog Scale for Pain Time: 12 months postoperative
Description: Equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.
Measure: Change in Oswestry Disability Index for Pain and Function Time: 12 months postoperative
Description: Equal to or greater than 15-point increase in patient reported outcomes as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.
Measure: Change in Short Form Health Survey-36 for Quality of Life Time: 12 months postoperative
Description: Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.
Measure: Neurological Deficit per Lumbar Spine Neurological Exam Time: 12 months postoperative
Description: Count of participants with revision surgery by month 12
Measure: Count of participants with revision surgery by month 12 Time: 12 months postoperative
Description: Count of participants developing pseudoarthrosis by month 12
Measure: Count of participants developing pseudoarthrosis by month 12 Time: 12 months postoperative
2 An Observational Study of Integrated Chronic Pain Management in a Community Health Center
Primary Outcomes
Description: Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
Measure: Incidence of successful Lumbar Fusion measured radiographically Time: 12 months postoperativeSecondary Outcomes
Description: Equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months.
Measure: Visual Analog Scale for Pain Time: 12 months postoperativeDescription: Equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.
Measure: Change in Oswestry Disability Index for Pain and Function Time: 12 months postoperativeDescription: Equal to or greater than 15-point increase in patient reported outcomes as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.
Measure: Change in Short Form Health Survey-36 for Quality of Life Time: 12 months postoperativeDescription: Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.
Measure: Neurological Deficit per Lumbar Spine Neurological Exam Time: 12 months postoperativeDescription: Count of participants with revision surgery by month 12
Measure: Count of participants with revision surgery by month 12 Time: 12 months postoperativeDescription: Count of participants developing pseudoarthrosis by month 12
Measure: Count of participants developing pseudoarthrosis by month 12 Time: 12 months postoperativeThis was a prospective observational study with the primary objective of quantifying a change in pain scores after 6-12 months of two separate interventions within the study site (pain team and chiropractic team). Target enrollment was 30 participants for each intervention. The primary outcome was a change from baseline of the Pain Disability Questionnaire (PDQ), the study tool. Secondary outcomes were reduction of opioid dose by morphine equivalent daily dose, and its effect on PDQ scores.
NCT04490291 Chronic Pain Spine Disease Other: chronic pain team Other: chiropractic team MeSH:Spinal Diseases Chronic Pain
HPO:Chronic pain
Primary Outcomes
Description: 6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)
Measure: change in Pain Disability Questionnaire (PDQ) score Time: 6-12 month
Secondary Outcomes
Description: ability to successfully wean off opioid prescription
Measure: prescription opioid weaning Time: 6-12 months
HPO Nodes
Primary Outcomes
Description: 6-12 month follow up pain score - (minus) baseline. scores range from 0 (no pain or disability) to 150 (severe pain and disability)
Measure: change in Pain Disability Questionnaire (PDQ) score Time: 6-12 monthSecondary Outcomes
Description: ability to successfully wean off opioid prescription
Measure: prescription opioid weaning Time: 6-12 months