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IRCT20200114046128N1 IRCT 2020-03-15 Artesh University of Medical Sciences A randomized, double-blind controlled trial study comparing the efficacy of granisetron versus lidocaine injection of trigger points in upper trapezius of patients with Myofascial Pain Syndrome referring to the AJA University Hospital A randomized, double-blind controlled trial study comparing the efficacy of granisetron versus lidocaine injection of trigger points in upper trapezius of patients with Myofascial Pain Syndrome referring to the AJA University Hospital 2018-09-23 anticipated 40 Complete https://irct.ir/trial/45027 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For random allocating of two groups with the same size of 20 participants (40 patients in total) we used block randomization with different block sizes. The sizes of blocks would be a multiple of 2 and a divisor of 40 (2,4,8). At first, the block sizes were selected randomly. Then, for each block, different permutations for equal group size were determined. Finally, one of the permutations was selected randomly. Random numbers were generated in an independent statistical office and with the help of a computer, Blinding description: Our study was a double-blind randomized trial. The participants, investigators, and clinicians were unaware of the treatment assignments. The sequence of allocation was concealed from all investigators and participants with sequentially numbered sealed envelopes prepared at the statistical office. The envelopes contained cards with the group assignments type. A nurse who was neither involved in the intervention nor in the assessments opened the envelope and prepared the solutions for injection based on the treatment assignments. The solution was then injected by a physician blinded to its content. All follow-up evaluations were done by a physical therapist blinded to the group assignment. N/A neck and upper trapezius pain. Intervention 1: Intervention group: patients with complain of Neck pain or Shoulder pain and clinical diagnosis of Myofascial Pain Syndrome in Upper trapezius muscle, single dose 1CC Granisetron (produced by Caspian Co.) were injected. Intervention 2: Intervention group: patients with complain of Neck pain or Shoulder pain and clinical diagnosis of Myofascial Pain Syndrome in Upper trapezius muscle, single dose 1CC Lidocaine 0.5% (produced by Caspian Co.) were injected. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Need to make a decision at the university research council
public Reza Mohtasham
501 Hospital, Etemadzade,West Fatemi Blvd
Tehran Iran (Islamic Republic of) 1411718541 +98 21 6666 1211 Reza.mohtasham51@gmail.com Artesh University of Medical Sciences scientific Sharif Najafi
No etemadzade 501 hospital
Tehran Iran (Islamic Republic of) 6666677777 +98 21 8888 1211 setarekavireiran@yahoo.com Artesh University of Medical Sciences Iran (Islamic Republic of) Being at least 18 years old Neck or shoulder pain complaints for at least one month At least one trigger point in the upper trapezius muscle Non pregnant woman No prior disease (severe cystic, spine, spinal canal stenosis) No history of fibromyalgia or rheumatic diseases No prior history of allergy to Granisetron or lidocaine 18 years no limit Both No patient co-operation No refer for follow up Pain aggravation (unbearable for patient) M79.1 Myalgia Treatment - Drugs Treatment - Drugs Intervention group: patients with complain of Neck pain or Shoulder pain and clinical diagnosis of Myofascial Pain Syndrome in Upper trapezius muscle, single dose 1CC Granisetron (produced by Caspian Co.) were injected Intervention group: patients with complain of Neck pain or Shoulder pain and clinical diagnosis of Myofascial Pain Syndrome in Upper trapezius muscle, single dose 1CC Lidocaine 0.5% (produced by Caspian Co.) were injected Severity of neck pain with Visual Analogue Scale. Timepoint: pain severity at start, one month and 3 months later. Method of measurement: Visual Analogue Scale. NDI. Timepoint: Neck disability index at start, one month and 3 months later. Method of measurement: Neck Disability Index. NPDS. Timepoint: Neck pain and disability scale at start, one month and 3 months later. Method of measurement: Neck Pain and Disability Scale. Aja university Approved 2019-12-23 Ethics Committee of Artesh University of Medical Scinces 501 Hospital, Etemadzade Ave, West Fatemi Blvd Tehran Tehran Iran (Islamic Republic of)