A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With Allodynia
ClinicalTrials.gov · 2005
OBJECTIVES: Chronic low back pain (cLBP) is prevalent among agricultural workers in Surin Province, Thailand. This study evaluated the efficacy and safety of Thai massage combined with the traditional herbal formula (YTPS) in reducing pain and improving mobility in individuals with cLBP.
METHODS: A single-blind, randomized controlled trial was conducted with 66 participants assigned to three groups (n=22 each): (1) herbal remedy (Hr) group, receiving 2,000 mg of YTPS twice daily for seven days; (2) Thai massage (Tm) group, receiving massage therapy three times per week; and (3) combined therapy (Tm+Hr) group, receiving both interventions. The active compounds of YTPS were identified by HPLC, and antioxidant capacity was evaluated using DPPH and ABTS assays. Pain and functional outcomes were assessed using the Numerical Rating Scale (NRS), Goniometer (GOM), Flexible Ruler (FR), and Oswestry Disability Index (ODI). Biochemical safety parameters (BUN, creatinine, AST, ALT) and oxidative stress markers (MDA, CAT, GSH, SOD) were analyzed before and after treatment.
RESULTS: HPLC revealed piperine (19.6 µg) and cannabidiol (5.09 µg) as key active constituents with antioxidant potential. All groups demonstrated improved oxidative profiles, with increased CAT, GSH, and SOD levels and reduced MDA concentrations. The combined therapy group (Tm+Hr) showed the greatest improvements in NRS, GOM, and ODI scores (p<0.05). No significant adverse biochemical changes were observed.
CONCLUSIONS: A seven-day regimen combining Thai massage with YTPS safely and effectively reduced pain and disability while enhancing antioxidant activity. This integrative approach may serve as a practical and culturally relevant therapy for managing chronic low back pain in community healthcare settings.
ClinicalTrials.gov · 2005
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