Tolperisone for Muscle Spasm Associated with Intervertebral Disc Protrusion
Tolperisone should not be used for muscle spasm associated with intervertebral disc protrusion, as traditional "muscle relaxants" do not actually relieve true muscle spasm and their effects are nonspecific, while tolperisone specifically lacks established evidence for disc-related pain conditions. 1
Critical Evidence Gap for Disc-Related Conditions
The available evidence for tolperisone is limited to acute, non-specific low back pain with muscle spasm, not pain specifically associated with intervertebral disc protrusion:
Tolperisone studies have only evaluated acute muscle spasm of the back without documented disc pathology 2, 3. The Phase 2 STAR study and ongoing Phase 3 RESUME-1 trial specifically enrolled patients with "back pain due to acute muscle spasm" but did not require or document disc protrusion 2, 3.
One comparative study showed tolperisone improved pain scores and range of motion in acute low back pain with spasm, but again without specific evaluation of disc-related pathology 4.
Why Traditional Muscle Relaxants Are Inappropriate
The fundamental problem is that so-called "muscle relaxants" do not actually relieve muscle spasm:
Muscle relaxant drugs may relieve skeletal muscle pain, but their effects are nonspecific and not related to muscle relaxation 1. They should not be prescribed in the mistaken belief that they relieve muscle spasm 1.
If true muscle spasm is suspected, drugs with known effects on muscle spasm (benzodiazepines or baclofen) should be considered instead 1.
Many muscle relaxants are associated with greater risk for falls in older persons 1.
Appropriate Management for Disc Protrusion
For muscle spasm associated with intervertebral disc protrusion, evidence-based approaches include:
Conservative management with physical therapy and medical management is first-line for acute low back pain with or without radiculopathy, as this is a self-limiting condition in most patients 1.
Imaging abnormalities including disc protrusion are common in asymptomatic patients - disc protrusion prevalence ranges from 29% in 20-year-olds to 43% in 80-year-olds without symptoms 1.
The majority of disc herniations show some degree of reabsorption or regression by 8 weeks after symptom onset 1.
If true paravertebral muscle spasm exists in the context of disc disease, external brace immobilization may be more appropriate than pharmacologic intervention 1.
Safety Concerns with Tolperisone
While tolperisone appears better tolerated than traditional muscle relaxants:
The most common adverse events are headache (7.1%) and diarrhea (2.4%) 3.
Importantly, prophylactic tolperisone resulted in reduced isometric force in one study, suggesting potential functional impairment 5.
Somnolence rates are low (1.2%), which is favorable compared to traditional muscle relaxants 3.
Clinical Bottom Line
For disc protrusion with associated symptoms, focus on evidence-based interventions: conservative management with physical therapy for 4-6 weeks, NSAIDs for pain control, and consideration of epidural steroid injections or surgical consultation if conservative measures fail 1. Avoid tolperisone and other "muscle relaxants" as they lack specific efficacy for disc-related pathology and do not address the underlying problem.