PURPOSE: To investigate the efficacy and safety of intraarticular sodium hyaluronate (SH) compared with intraarticular glucocorticoids (triamcinolone acetonide; TA) in the treatment of chronic nonradicular lumbar pain. MATERIALS AND METHODS:Sixty patients were included in this randomized, controlled, blind-observer clinical study and randomly assigned to two groups to receive 10 mg SH or 10 mg TA per facet joint. The facet joints on both sides at levels S1-L5, L5-L4, and L4-L3 were treated once per week under computed tomographic guidance. The study visits were timed to permit assessment of the immediate effect as well as possible carryover effects at 3 and 6 months after completion of treatment. Changes in pain were assessed with a visual analog scale (VAS) and changes in function and quality of life were assessed by the Roland Morris Questionnaire (RMQ), the Oswestry Disability Questionnaire (ODQ), the Low Back Outcome Score (LBOS), and the Short Form 36 (SF-36) questionnaire. RESULTS: Patients reported lasting pain relief, better function, and improved quality of life with both treatments. Mann-Whitney analyses of the patient questionnaires (RMQ, ODQ, and LBOS) very consistently showed that SH is not inferior to TA. In addition, the efficacy of SH was largely comparable with that of TA on the VAS and SF-36. No adverse effects were reported after administration of the test products. The intraarticular treatment of facet joints (levels S1-L5, L5-L4, and L4-L3) with SH in patients with chronic nonradicular pain in the lumbar spine 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. CONCLUSION:Intraarticular SH is a very promising new option for the treatment of patients with chronic nonradicular lumbar symptoms.
RCT Entities:
PURPOSE: To investigate the efficacy and safety of intraarticular sodium hyaluronate (SH) compared with intraarticular glucocorticoids (triamcinolone acetonide; TA) in the treatment of chronic nonradicular lumbar pain. MATERIALS AND METHODS: Sixty patients were included in this randomized, controlled, blind-observer clinical study and randomly assigned to two groups to receive 10 mg SH or 10 mg TA per facet joint. The facet joints on both sides at levels S1-L5, L5-L4, and L4-L3 were treated once per week under computed tomographic guidance. The study visits were timed to permit assessment of the immediate effect as well as possible carryover effects at 3 and 6 months after completion of treatment. Changes in pain were assessed with a visual analog scale (VAS) and changes in function and quality of life were assessed by the Roland Morris Questionnaire (RMQ), the Oswestry Disability Questionnaire (ODQ), the Low Back Outcome Score (LBOS), and the Short Form 36 (SF-36) questionnaire. RESULTS:Patients reported lasting pain relief, better function, and improved quality of life with both treatments. Mann-Whitney analyses of the patient questionnaires (RMQ, ODQ, and LBOS) very consistently showed that SH is not inferior to TA. In addition, the efficacy of SH was largely comparable with that of TA on the VAS and SF-36. No adverse effects were reported after administration of the test products. The intraarticular treatment of facet joints (levels S1-L5, L5-L4, and L4-L3) with SH in patients with chronic nonradicular pain in the lumbar spine 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. CONCLUSION: Intraarticular SH is a very promising new option for the treatment of patients with chronic nonradicular lumbar symptoms.
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