A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Early Lumbar Disc Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01158924 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intradiscal rhGDF-5 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- DePuy Spine
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurological Assessment for Motor Function and Reflexes/Sensory |
0; 2 | — |
| PRIMARY Treatment Emergent Adverse Events- Relationship to Study Drug |
2; 1 | — |
| SECONDARY Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline |
-13.0; -18.1 | — |
| SECONDARY Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline. |
-2.66; -3.80 | — |
| SECONDARY Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline. |
11.18; 10.00 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Persistent low back pain with at least 3 months of non-surgical therapy at one or two suspected symptomatic lumbar levels (L3/L4 to L5/S1)
a. The recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of MRI, CT and/or Technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury).
- Oswestry Disability Index (ODI) for low back pain of 30 or greater
- Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
- Male or Female 18 years of age or older
Exclusion Criteria
- Persons unable to have an MRI
- Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
- Persons with neurological or radiographic evidence of active radicular pain due to anatomical compression such as stenosis or disc herniation (persons with somatic referred pain are allowed)
- Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments
- Suspected symptomatic sacro-iliac joint
Data sourced from ClinicalTrials.gov (NCT01158924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.