Study of Two Platelet-Based Injections Given 4 Weeks Apart for Treating Painful Lumbar Degenerative Disc Disease

What this Trial Is About

Researchers are evaluating two platelet-based treatments spaced four weeks apart compared to sham procedures for treating painful lumbar degenerative disc disease. This single-blind, randomized, placebo-controlled study aims to observe improvements in patient-reported outcomes from baseline to three months after the second treatment, with ongoing assessment of effectiveness and durability up to twelve months. The study includes adults aged 25 to 65 years with confirmed degenerative disc disease who have not responded to prior conservative treatments. Participants receive either two treatments involving platelet-rich plasma, platelet lysate, and platelet poor plasma injections into specific areas of the lumbar spine or two sham procedures mimicking the treatment without injecting any substances. The treatments involve drawing and processing the patients blood, followed by ultrasound or x-ray guided injections into the multifidus muscle, epidural space, facet joints, tendon insertions, and ligaments at the affected spinal levels. The sham group undergoes needle placements without injections. After three months, patients in the sham group may crossover to receive the real treatment and continue follow-up accordingly. Participants attend a pretreatment visit at or before enrollment, with follow-up visits at three and twelve months post-injection. They complete questionnaires assessing pain and function at one, three, six, and twelve months. Researchers measure outcomes including pain scales, functional indexes, disability scores, medication use, adverse events, and additional treatments. The total participation lasts up to one year with ongoing monitoring of clinical outcomes and safety throughout the study period.

Trial for Treating Painful Degenerative Disc Disease