Efficacy and tolerability of the pharmaconutraceutical complex Theraflex Ultra in the treatment of patients with chronic non-specific lower back pain due toprimarily discogenic pathology (FORSAGE study)

Zh Nevrol Psikhiatr Im S S Korsakova. 2026;126(5):108-114. doi: 10.17116/jnevro2026126051108.

ABSTRACT

OBJECTIVE: To evaluate the efficacy and tolerability of the pharmaconutraceutical complex, Theraflex Ultra, based on undenatured (native) type II collagen, in the treatment of discogenic chronic low back pain (CLBP).

MATERIAL AND METHODS: This open, multicenter, observational study included 50 patients (28 women and 22 men; mean age 48.3 years [45.5; 52.2]) diagnosed with CLBP, mostly associated with discogenic pathology, as confirmed by clinical evaluation and neuroimaging. The study group (n=25) received standard therapy comprising non-steroidal anti-inflammatory drugs (NSAIDs) for 10 days, a centrally acting muscle relaxant for 14 days, and a high-dose vitamin B complex for 21 days, combined with Theraflex Ultra at 2 capsules twice daily for 2 months. The control group (n=25) received only the standard therapy. Efficacy was assessed after 1, 2, and 3 months using various scales, including the Numeric Rating Scale for Pain (NRS-P), the Douleur Neuropathique 4 (DN4), the Back Pain Functional Scale (BPFS), and the Medical Outcomes Study Short Form 36 (MOS SF-36). The relapse rate during the first year post-enrollment in the study was also documented.

RESULTS: After one month, the study group exhibited a significantly greater reduction in pain intensity, as measured by the NRS-P, compared to the control group (23.2±8.8 versus 35.2±7.4; p<0.05). After two months, the study group demonstrated significant improvements in functional activity (BPFS: 51.7±15.7 vs. 40.2±13.1) and the physical component of quality of life (MOS SF-36: 86.8±5.5 vs. 77.2±8.1; p<0.05). No intergroup differences were noted on the DN4 scale, indicating nociceptive pain. Treatment adherence in the study group was high, with a score of 9.9±4.2 on the Adherence to Refills and Medications Scale (ARMS-7). A relapse occurred in 20% of patients in the study group and 32% in the control group after one year (relative risk [RR] 1.4 [confidence interval [CI] 0.513-3.824]; number needed to treat [NNT]=8.3). Adverse events were reported in all groups; however, they were mild and did not require treatment discontinuation.

CONCLUSION: The addition of Theraflex Ultra to the standard therapy regimen for discogenic chronic non-specific low back pain yields a significant reduction in pain intensity, enhanced functional activity and quality of life, and a decreased risk of relapse within a year. The product demonstrates high treatment adherence and favorable tolerability. Subsequent randomized studies are warranted to validate these findings.

PMID:42246534 | DOI:10.17116/jnevro2026126051108