TENS Versus Aceclofenac-Tizanidine for Orofacial Myofascial Pain Syndrome: A Randomized Controlled Trial in an Indian Cohort
摘要
Orofacial myofascial pain syndrome (MPS), a major subtype of temporomandibular disorders (TMD), commonly presents with facial pain, headache, and referred otalgia, often mimicking primary otologic disease. This prospective assessor-blinded randomized controlled trial evaluated the efficacy and safety of transcutaneous electrical nerve stimulation (TENS) compared with aceclofenac–tizanidine pharmacotherapy in patients diagnosed with orofacial MPS using Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Sixty adult patients were randomly allocated into two equal groups. The TENS group received daily TENS therapy for seven consecutive days using standardized parameters (40 Hz frequency, 100 µs pulse width, 15 min duration), while the pharmacotherapy group received aceclofenac 100 mg and tizanidine 2 mg twice daily for seven days. Pain intensity was assessed using the Visual Analog Scale (VAS) at baseline, Day 2, Day 5, and Day 8. Adverse events and treatment discontinuation were also evaluated. Both treatment modalities resulted in significant pain reduction; however, TENS demonstrated superior clinical efficacy. Mean VAS scores decreased from 8.00 ± 0.95 to 1.40 ± 1.07 in the TENS group compared with 8.20 ± 1.03 to 3.13 ± 1.04 in the pharmacotherapy group. A reduction of ≥50% in pain intensity was achieved in 86.7% of patients receiving TENS versus 56.7% receiving pharmacotherapy. No adverse effects were observed in the TENS group, whereas mild drowsiness and gastrointestinal discomfort occurred in the pharmacotherapy group, leading to treatment discontinuation in two patients. TENS therapy demonstrated superior analgesic efficacy and a more favorable safety profile compared with aceclofenac–tizanidine therapy in the management of orofacial myofascial pain syndrome. As a safe, non-invasive, and well-tolerated modality, TENS may represent an effective outpatient treatment option for patients with TMD-related myofascial pain.