Aim: Comparison of the efficacy of conservative treatment methods: epidural GOLDIC serum, epidural steroid injections, manual therapy. Materials & methods: A randomized, controlled trial. Three groups, each containing 30 patients. GOLDIC or steroid injections (dexamethasone) epidural versus manual therapy. Assessment: initial assessment and 4 (T1), 12 (T2) and 24 (T3) weeks after the last intervention. Primary outcomes: Pain intensity in numeric rating scale, Oswestry disability index, Zurich claudication questionnaire, EQ-5D-5L questionnaire. Results: GOLDIC has shown the highest mean differences and number of cases with minimal important difference among groups for every primary outcome. Conclusion: GOLDIC therapy could be a new option for the nonoperative, symptomatic treatment of degenerative lumbar spinal stenosis and is not inferior to epidural steroid injections and manual therapy.
Trial registration: ClinicalTrials.gov NCT04492774.
Keywords: biological products; injections; musculoskeletal manipulations; spinal stenosis; steroids.
This paper presents a comparative study of three methods of nonoperative treatment used in stenosis (narrowing) of the spinal canal in the lumbar region. The study was performed on 90 people with this kind of disease, which usually causes low back pain, combined with weakening of the muscle strength of the lower limbs and a significant shortening of walking distance. It turned out that autologous serum GOLDIC administered by epidural injection (into the vertebral canal) showed a stronger and longer-lasting analgesic effect and helped patients maintain better mobility during the 24-week follow-up period. Clinical Trial Registration: NCT04492774 (ClinicalTrials.gov).