Comparison of the Effectiveness of True and Sham Thread Embedding Acupuncture on Spasticity in Multiple Sclerosis Patients

Evaluation the effectiveness and comparing of True and Sham Thread Embedding in acupoints on Spasticity in Multiple Sclerosis

A concealed, block randomized, double-blinded, 3rd phase of sham controlled clinical trial with a parallel group design of 38 patients

Patients referred to the neurology clinic of Mashhad Qaem Hospital, suffering from MS, according to the inclusion criteria and the approval of the MS fellowship, are referred to the acupuncture clinic of Imam Reza hospital. After signing the informed consent form, first evaluations are performed. In addition to the routine neurological treatment, the participants are placed in two groups and 30 acupoints are intervented. In True Embedding intervention group, after disinfection, 2cm PDO threads are embedded in the acupoints by a 20 gauge needle. In the Sham control group, the needle is inserted in the same points for blinding, but the thread is not embedded in the tissue. To prevent infection, cephalexin and to control pain, cold compress or Ibuprofen are prescribed. After 4 and 12 weeks, the outcomes are evaluated.

Inclusion Criteria: Definite diagnosis of MS; EDSS<7; Age>18; Resistant spasticity; Signing informed consent. Non-Inclusion Criteria: Receiving acupuncture in the last 6 months; Relapse or changing maintenance treatment in the last 2 months; Severe chronic systemic disease, cancers and coagulopathy; Sensitivity to Cephalosporins or thread; Pregnancy, Breastfeeding or uncertain contraception

Intervention group: True Embedding of Polydioxanone Threads in 30 Acupoints. Sham control group: Needling in 30 Acupoints Without inserting Threads

Disability, Spasm, Walking quality, Daily life activities, Pain, Fatigue, Sleep, Urinary symptoms, Depression, Anxiety and Quality of life score

Expected recruitment end date and the McDonald's criteria 2024 were updated.

Using the online site www.sealedenvelope.com, random allocation is done in two groups A (intervention) and group B (control). Block Randomization will be done with block sizes of 4 and 6 for random allocation. The prepared blocks will be placed inside the envelope. One of the envelopes will be randomly selected according to the order of patients' arrival, and patients will be assigned to groups. Allocation concealment is done using sealed opaque envelopes. By one of the team members, random numbers will be prepared and placed inside the envelope. The envelopes will be closed and their contents will not be visible from the outside. First, the purpose of the study is explained to the person with entry requirement critrias. Then, the person signs the informed consent form and one envelope will be taken and opened and patient will be entered into one of the two groups.

In this study, the intervention group is True embedding group and the Sham group is designed as a control group, and the participants are thus blinded. The statistical analyst evaluates the information based on group A and B and is blinded to which group is belongs to A or B.