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IRCT20180909040977N1 IRCT 2019-01-08 Gorgan University of Medical Sciences The effect of leech therapy on carpal tunnel syndrome A comparison between leech therapy and medical treatment on clinical symptoms severity as well as nerve and muscle cord changes of patients with carpal tunnel syndrome in moderate grade. 2018-11-22 anticipated 60 Complete https://irct.ir/trial/33745 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be allocated to intervention and control groups based on four blocks randomization. The four blocks are entered into the SPSS software, and by mean of the "select random sample" field in SPSS, a one block randomly will be selected, Blinding description: In this study, data analyzer and an assessor who asks questionnaire on the 30th day from patient via telephone are blinded. N/A The effect of leech therapy on Nerve condition in carpal tunnel syndrome patients. Intervention 1: Intervention group: In the intervention group, the patient uses leech therapy in addition to receiving medical treatment (Tablets of Celecoxib 100 mg twice daily, Gabapentin 100 mg twice daily, vitamin B; 300 mg once daily for one month, using short cock-up splint, which should be used at bedtime). Leech therapy will be implemented once, on the first day and in the absence of improvement of pain and clinical symptoms will be used for the second time on the 15th day with the diagnosis of Iranian medicine expert. Four leeches will be placed on the wrist, on anatomical pathway of the medial nerve. Intervention 2: In the control group: the patient was treated purely with medical treatment, including tablets of Celecoxib 100 mg twice daily, Gabapentin 100 mg twice daily, vitamin B; 300 mg once daily for one month, plus a short cock up splint during sleep will be received. No - There is not a plan to make this available Justification or reason for not sharing IPD is Decision making in this regard is based on patient information data. By considering the confidentiality of information, decided to publish patient information by the authors will be done at the end of the study. Therefore, a program for the dissemination of information does not exist now

public Ali akbar Aghaeinejad

Paramedical School, The beginning of the road Shastakla-

Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 1664 dr.aghaeinejad@goums.ac.ir Gorgan University of Medical Sciences scientific Rozbe Shams amiri

5 Azar Hospital, Azar Avenue,

Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3222 0561 Rshamsa@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) The presence of clinical symptoms and having positive Tinel, Fallen and carpal compersion tests Having positive paraclinical findings (nerve conduction velocity and electromyography) detected by electrodiagnosis and the grades must be in intermediate level by neurologist and neurologist specialist diagnosis. Satisfaction should be gained by the use of one of two methods. Age between 30-60 years 30 years 60 years Both The presence of rheumatic disease, rheumatoid arthritis and other upper limb disorders, coagulation problems, diabetes, hypothyroidism, gout, lupus erythematosus, acromegaly, chronic kidney failure, and diseases that impede CTS symptoms. Pregnancy for up to a year and mental retardation and anemia Frequent fracture or trauma to the wrist and wrist surgery Injection of intra-articular corticosteroid in the wrists during the past 3 months Immune system disorders, severe allergic allergy, use of neuropathic drugs, use of non-steroidal anti-inflammatory drugs during the last two weeks History of stroke syndrome G56.1 Other lesions of median nerve Treatment - Other Treatment - Drugs Intervention group: In the intervention group, the patient uses leech therapy in addition to receiving medical treatment (Tablets of Celecoxib 100 mg twice daily, Gabapentin 100 mg twice daily, vitamin B; 300 mg once daily for one month, using short cock-up splint, which should be used at bedtime). Leech therapy will be implemented once, on the first day and in the absence of improvement of pain and clinical symptoms will be used for the second time on the 15th day with the diagnosis of Iranian medicine expert. Four leeches will be placed on the wrist, on anatomical pathway of the medial nerve. In the control group: the patient was treated purely with medical treatment, including tablets of Celecoxib 100 mg twice daily, Gabapentin 100 mg twice daily, vitamin B; 300 mg once daily for one month, plus a short cock up splint during sleep will be received. Abnormalities in electromyography and nerve study. Timepoint: Once on the first day of the study and once on day 60. Method of measurement: Electromyographic machine Nihon kohden model. Pain score on the analog scale visual pain. Timepoint: In 4 steps, at the beginning of the study (before treatment or leech therapy), on day 15, day 30 and day. Method of measurement: Visual Analogue Scale. Severity of symptoms and functional status. Timepoint: In 4 stages, at the time of entering the study (before treatment or leech therapy), on day 15, day 30 and day 60. Method of measurement: Boston Clinical Symptom Intensity Questionnaire. Gorgan University of Medical Sciences Approved 2018-07-29 Ethics Committee of Golestan University of Medical Sciences The beginning of the road is Shastcolaa Gorgan Golestan Iran (Islamic Republic of)