Fuchs 2005

Sixty patients were included in the randomised, controlled, blind-observer clinical study.
For the primary efficacy analysis (intent-to-treat data set), 29 patients were included in the SH group and 30 in the TA group, as one patient in the SH group was excluded from efficacy evaluation due to an exclusion criterion being met.

This was a single-center study.
Patient treatment was performed in Coesfeld, Germany, under the scientific guidance of Münster University.

Group 1 received 10 mg sodium hyaluronate (SH) per facet joint (Ostenil mini).
Group 2 received 10 mg triamcinolone acetonide (TA) per facet joint (a glucocorticoid).

Treatment involved one injection per week into the facet joints on both sides at levels S1–L5, L5–L4, and L4–L3.
All injections were performed under computed tomographic (CT) guidance to ensure they were strictly intraarticular.
Each patient ultimately received six injections of the assigned test product.

Persistent pain in the lumbar spine for at least 3 months before the study.
Radiologic confirmation of facet joint osteoarthritis (OA) of Kellgren grade 2/3.
Good general and nutritive condition.
Patients had to provide written informed consent.

History of hypersensitivity or contraindication to the test products or their constituents.
Contraindication to intraarticular treatment.
Current regimen of anticoagulants.
Radicular pain or other conditions that could interfere with findings of nonradicular low back pain (determined by clinical examination or CT scan).

Pain intensity, assessed with the 100-mm Huskisson visual analog scale (VAS).

Both treatments caused a marked decrease in the initial severity of pain.
SH group: Mean pain decreased by 40.1% (immediate effect at visit 5) and 45.1% (carryover effect at visit 7) from baseline.
TA group: Mean pain decreased by 56.2% (immediate effect at visit 5) and 51.7% (carryover effect at visit 7) from baseline.
Statistical analysis of the VAS scores for pain did not show noninferiority of SH versus TA.

Changes in function and quality of life, assessed by the Roland Morris Questionnaire (RMQ), Oswestry Disability Questionnaire (ODQ), Low Back Outcome Score (LBOS), and Short Form 36 (SF-36) questionnaire.

Patients reported lasting pain relief, better function, and improved quality of life with both treatments.
RMQ: Both treatments reduced impairment in everyday activities. The carryover effect (at visit 7) was somewhat greater with SH (43.2% reduction) than with TA (33.4% reduction). Noninferiority of SH versus TA was shown at visits 6 and 7.
ODQ: The degree of impairment also decreased sharply in both groups. The carryover effect (at visit 7) for SH (39.1% improvement) was slightly greater than that for TA (29.5% improvement). Noninferiority of SH versus TA was shown at visits 6 and 7.
LBOS: Scores improved for both groups. The carryover effect (at visit 7) of SH was more pronounced (43.9% improvement) than that of TA (34.8% improvement). Noninferiority of SH versus TA was shown at visits 6 and 7.
SF-36: One week after treatment completion, seven of eight items showed improvement in the SH group, particularly physical function, functional limitation from physical problems, and physical pain. Similar improvements were observed in the TA group. At visit 7, functional limitation from emotional problems also improved markedly in the SH group.
Overall: Mann-Whitney analyses of RMQ, ODQ, and LBOS consistently showed that SH is not inferior to TA. The efficacy of SH was largely comparable with that of TA on the VAS and SF-36. SH-treated patients showed greater benefits in the long term.

Intraarticular SH is a very promising new option for the treatment of patients with chronic nonradicular lumbar symptoms.
Intraarticular treatment of facet joints with SH resulted in a marked reduction in pain with improved function and better quality of life, which was at least equal to the effect of a course of TA injections.
SH-treated patients showed greater benefits in the long term.
No adverse effects were reported after administration of the test products.
A comparative benefit/risk analysis favors the administration of intraarticular SH in the treatment of facet joint OA.

Patients were assessed by a different investigator who was masked to the treatment received, helping to avoid bias.

CT guidance was used for all intraarticular injections, ensuring precise delivery into the small articular capsule, which is crucial for optimising effect.
Validated scales and patient questionnaires were used for efficacy data.
The study investigated non-inferiority, which is relevant given glucocorticoids (TA) are an established treatment for facet OA.
No significant adverse events caused by the test products were reported.
Intraarticular SH has fewer contraindications and less frequent, milder local adverse effects compared to glucocorticoids, making its benefit/risk profile more favourable.

It was a single-center study.
The primary efficacy endpoint (VAS pain scores) did not show statistical noninferiority of SH versus TA.
Only one injection per joint was performed; future studies could explore whether more injections, especially at more severely degenerated levels like L5, might lead to even greater improvement.
The study used CT guidance, which is precise but future studies should investigate if simpler, less resource-intensive methods like image converters or ultrasonography would be adequate for reliable intraarticular delivery.