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IRCT20180731040647N1 IRCT 2019-02-24 Tehran University of Medical Sciences Effect of Frankincense on carpal tunnel syndrome Evaluation the effectiveness of Frankincense on symptoms,signs & electrodiagnostic parameters of patients with carpal tunnel syndrome. 2018-11-06 anticipated 36 Complete https://irct.ir/trial/34831 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Subject selection will be done by simple randomization among patients with Carpal Tunnel Syndrome ,coming to physical medicine & rehabilitation clinics affiliated with Tehran University of Medical Sciences in 2018-2019. Treatment allocation was constructed with table of random numbers . In addition, numbered opaque envelopes used to conceal random sequence, Blinding description: The study is triple blind. The patients ,the clinical teams and the people who analyze the data are kept blind. 3 carpal tunnel syndrome. Intervention 1: Intervention group: they go under treatment of topical product,derived from Frankincense ,every other 12 hours for 6 weeks on their volar surface of wrist.they also wear cock up splints as a standard care for mild or moderate carpal tunnel syndrome. Intervention 2: Control group: they go under treatment of placebo,which is completely similar to drug in appearance,color and viscosity ,every other 12 hours ,for 6 weeks on their volar surface of wrist.they also wear cock up splints as a standard care for mild or moderate carpal tunnel syndrome. 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 there is no more information.
public Setareh Rohani Shahraki
No. 49 , 7th floor,C2 block, 1st phase ,Ekbatan town,Tehran
tehran Iran (Islamic Republic of) 8164743533 +98 21 4464 0337 setarehhhr87@gmail.com Tehran University of Medical Sciences scientific Setareh Rohani Shahraki
No. 49 , 7th floor,C2 block, 1st phase ,Ekbatan town,Tehran
tehran Iran (Islamic Republic of) 8164743533 +98 21 4464 0337 setarehhhr87@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients aged >=18 years Patients with unilateral or bilateral mild or moderate CTS Patients who heve at least two signs or one sign and one symptom of CTS, such as numbness, paresthesia, positive Tinel or Phalen tests patients who agreed to participate in this study 18 years no limit Both Patients with severe CTS Patients with history of previous surgical release of the median nerve Patients with sequelae of fracture of the wrist Patient who have intra canal corticosteroids injection in the last 6 months Patients with cervical radiculopathy Patient who have taken analgesics or cortcosteroid Patients with any undelying disease such as DM, CRF, neuropathy Alcoholic patients Patients who have allergy to drug or placebo Patients who do not agree to participate or who do not sign the consent form G56.0 Mononeuropathies of upper limb,urrent traumatic nerve disorder,Carpal tunnel syndrome Treatment - Drugs Placebo Intervention group: they go under treatment of topical product,derived from Frankincense ,every other 12 hours for 6 weeks on their volar surface of wrist.they also wear cock up splints as a standard care for mild or moderate carpal tunnel syndrome. Control group: they go under treatment of placebo,which is completely similar to drug in appearance,color and viscosity ,every other 12 hours ,for 6 weeks on their volar surface of wrist.they also wear cock up splints as a standard care for mild or moderate carpal tunnel syndrome. Pain score based on visual analogue scale. Timepoint: Before intervention and 2,6 weeks after intervention. Method of measurement: Visual Analogue Scale. Grip power in affected hand. Timepoint: Before intervention and 2 and 6 weeks after intervention. Method of measurement: hand dynamometry. Electrodiagnostic parameters including median sensory and motor nerve conduction studies to determine initial latency and base to peak amplitude are registered. Timepoint: Before intervention and 2,6 weeks after intervention. Method of measurement: Electrodiagnostic machine. Symptom severity scale & functional status scale. Timepoint: Before intervention and 2,6 weeks after intervention. Method of measurement: Boston Questionnaire. Tehran University of Medical Sciences Approved 2018-02-12 Ethics committee of Tehran university of Medical Sciences Ghods St, Keshavarz Blvd,Tehran Province, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)