Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia

Summary

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common.Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist with skeletal muscle relaxant, sedative and anxiolytic properties.we carried out an open-label clinical trial in order to evaluate the efficacy and safety of combined treatment with tizanidine and pregabalin for pain in FM.

Timeline

Start

2026-01-30

Primary completion

2026-05

Completion

2026-08

Publications

• Liu Q, Wen C, Dai Y, Ma T, Liu M, Jia Z, Luo F, Wang D. Efficacy and Safety of Pregabalin-Tizanidine vs Pregabalin in Patients with Fibromyalgia: Study Protocol for a Multicenter, Prospective, Randomized, Controlled, Open-Label, Blinded Endpoint Trial. J Pain Res. 2026 May 15;19:605429. doi: 10.2147/JPR.S605429. eCollection 2026.

Drugs

Indications