]>
IRCT20190618043931N1 IRCT 2020-01-20 Esfahan University of Medical Sciences Role of low level laser therapy on pain intensity and quality of life in patients with diabetic neuropathy Role of low level laser therapy on pain intensity and quality of life in patients with diabetic neuropathy 2016-03-20 anticipated 40 Complete https://irct.ir/trial/40403 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 40 patients with diabetic polyneuropathy (DNP) for 4 weeks would be enrolled in this double-blind randomized clinical trial. Patients will be randomized to receive placebo (sham laser) treatment (n = 20) or low level energy laser (n = 20). For randomization every patient will be pointed by a cod and after that every cod will be selected by provided randomization table. The score of VAS and SF36 will be evaluated in all of the patients in both groups immediately after, 2 and 4 weeks later, Blinding description: In this study the physician who evaluate the VAS criteria and SF36 forms of the patients (out put) will not know anything about the therapeutic method which is used for any patients. The method of therapy is also blind for patient. N/A Painful diabetic neuropathy: Painful diabetic neuropathy (PDN) is a common and debilitating complication of both types of diabetes mellitus. With this disorder the patients’ sleep, mood, function and mainly quality of life (QOL) will be disturbed.. Intervention 1: Intervention group: These patients will receive 8 sessions of low power laser. Treatments were administered twice weekly for 4 weeks. Intervention 2: Control group: These patients will recive 8 sessions of sham (non effectivee) laser. Treatments were administered twice weekly for 4 weeks. Yes - There is a plan to make this available What will be shared: A portion of the information, such as information on the main outcome or the like, can be shared. When: Starting the access period 6 months after printing results To whom: Researchers working in academic institutions Conditions: No specific conditions. Where to obtain: Contact the author and researcher How to obtain: By emailing or calling the author as soon as you respond to the data requestor, you can access the data Comments:
public Najmeh Zare Zardini
Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3668 0048 zarenajme920@gmaail.com Esfahan University of Medical Sciences scientific Najmeh Zare Zardini
Isfahan University of Medical Sciences, Hezar Jerib Ave.,
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3668 0048 zarenajme920@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with painful peripheral neuropathy older than 18 years of age Willingness to participate in the research project (filling the consent letter) 18 years no limit Both malignancy Active or untreated thyroid disease Infection with other known neurological and masculo-skeletal disorders simultaneously in the lower extremity E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Rehabilitation Placebo Intervention group: These patients will receive 8 sessions of low power laser. Treatments were administered twice weekly for 4 weeks. Control group: These patients will recive 8 sessions of sham (non effectivee) laser. Treatments were administered twice weekly for 4 weeks. Pain and quality of life in patients with diabetic neuropathy. Timepoint: Before the intervention, immediately, 1 week and 1 week after the end of treatment in each group. Method of measurement: Pain intensity using VAS criteria and quality of life using SF36 questionnaire. Esfahan University of Medical Sciences Approved 2017-05-22 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib street, Isfahan Isfehan Iran (Islamic Republic of)