A Prospective, Randomized, Multicenter, Open-label Clinical Trial Comparing Intradiscal Biacuplasty to Conventional Medical Management for Discogenic Lumbar Back Pain
Bibliographic record
Abstract
STUDY DESIGN: This study was a prospective, randomized, crossover, multicenter trial for the evaluation of comparative effectiveness of intradiscal biacuplasty (IDB) versus conventional medical management (CMM) in the treatment of lumbar discogenic pain. OBJECTIVE: The objective was to demonstrate the superiority of IDB over CMM in the treatment of discogenic pain with respect to the primary outcome measure. SUMMARY OF BACKGROUND DATA: Current therapeutic options for the treatment of chronic low back pain of discogenic origin are limited. CMM is often unsatisfactory with regard to the treatment of discogenic pain. IDB offers a minimally invasive treatment that has been demonstrated to be superior to placebo in the past. METHODS: A total of 63 subjects with lumbar discogenic pain diagnosed via provocation discography were randomized to IDB + CMM (n = 29) or CMM-alone (n = 34). At 6 months, patients in the CMM-alone group were eligible for crossover if desired. The primary outcome measure was the change in visual analog scale (VAS) from baseline to 6 months. Secondary outcome measures included treatment "responders," defined as the proportion of subjects with a 2-point or 30% decrease in VAS scores. Other secondary measures included changes from baseline to 6 months in (1) short form (SF) 36-physical functioning, (2) Oswestry Disability Index, (3) Beck Depression Inventory, (4) Patient Global Impression of Change, (5) EQ-5D VAS, and (6) back pain-related medication usage. RESULTS: In the IDB cohort, the mean VAS score reduction exceeded that in the CMM cohort (-2.4 vs. -0.56; P = 0.02), and the proportion of treatment responders was substantially greater (50% vs. 18%). Differences in secondary measures favored IDB. No differences in opioid utilization were noted between groups. CONCLUSION: Superior performance of IDB with respect to all study outcomes suggests that it is a more effective treatment for discogenic pain than CMM-alone. LEVEL OF EVIDENCE: 2.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".