True Versus Sham Thread Embedding Acupuncture for Spasticity-Related Symptoms and Disabilities in Multiple Sclerosis: Study Protocol of a Randomized Controlled Trial

Abstract

Introduction: Multiple sclerosis (MS) is a chronic autoimmune disease and one of the most common causes of non-traumatic disability in young adults, with over 2.8 million individuals worldwide. Spasticity affects nearly 80% of people with MS (PwMS), contributing to pain, gait disturbance, bowel/bladder dysfunction, sleep/mood disorders, and impaired quality of life. The complex condition known as Spasticity-Plus syndrome is gaining attention. Current pharmacological treatments are limited by side effects and short duration of benefits. Thread Embedding Acupuncture (TEA), which involves embedding absorbable polydioxanone (PDO) sutures into acupoints, offers prolonged stimulation and has shown promise in managing spasticity, particularly after stroke. Several randomized controlled trials (RCTs) have reported positive effects in MS. This is a study that protocol aims to evaluate the efficacy and safety of True TEA (TTEA) compared with Sham TEA (STEA) in reducing spasticity and improving mobility and related symptoms among PwMS. Methods: This is a protocol of a randomized, sham-controlled, patient-, assessor- and analyst-blinded, superiority clinical trial. Thirty-eight eligible PwMS with moderate-to-severe spasticity will be randomized 1:1 to either TTEA or STEA. Both groups will undergo puncture at the same 30 acupoints but only the TTEA group will receive PDO thread implantation. The primary outcome is change in disability (EDSS). Secondary outcomes are Numeric Rating Scale for Spasticity (NRS-S), walking ability (MSWS-12), activities of daily living (Barthel Index), pain (McGill Pain Questionnaire), fatigue (MFIS), sleep quality (PSQI), urinary symptoms (ABSST), mood (HADS), quality of life (EQ-5D-5L), overall treatment satisfaction, willingness to repeat and recommendation to others. Assessments will be conducted at baseline, 4 weeks, and 12 weeks post-intervention. Intention-to-treat analysis will be performed. Perspective: To our knowledge this trial will be the first RCT to evaluate TEA in spasticity-related symptoms in PwMS. By using a sham-controlled design, it will determine whether TEA confers benefits beyond needle puncture alone. Findings may provide evidence for incorporating TEA as a complementary option in MS symptom management and inform future larger-scale trials. Trial registration: IRCT20121228011912N8 (22 March 2024; Updated: 13 July 2026).