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IRCT20210702051760N1 IRCT 2022-03-29 The University of Lahore Teaching Hospital Effects of low-level laser therapy in addition to conventional physical therapy on pain and numbness Effects of low-level laser therapy in addition to conventional physical therapy on pain and numbness of lower limb in patients with diabetic peripheral neuropathy: a randomized controlled trial 2021-07-26 anticipated 43 Complete https://irct.ir/trial/57248 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Computer generated randomization assignments will be designed by an independent statistician and randomization will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis. The computer will randomly place the participants into control group and experimental group. The randomization assignments will be kept in opaque, sealed envelopes and unsealed by a researcher after baseline testing. Outcome assessors will be unaware of group assignment. The experiment will be started on the day after randomization, Blinding description: Only the participants will be blinded. As both groups will be treated in prone lying and both, the participant and the care provider, will be wearing laser protection goggles, the participants will not be able to identify whether the laser probe is emitting any rays or not. 2-3 Diabetic Peripheral Neuropathy. Intervention 1: Intervention group: In experimental group, patients will receive 20-25 minutes of therapy session including 5 minutes of LLLT on lumbosacral area and plantar surface of foot each, along with the conventional therapy, including TENS for 15 minutes on lumbosacral area and plantar surface of foot having rectangular wave, 100µs pulse width, 150Hz frequency and 20mA intensity. TENS will be used on both sites at the same time. The 19 diode cluster head of the Laser 755 model will be used which have a wavelength of 640 nm (visible) and 950 nm (infrared) and a power of 10 mW (visible) and 15 mW (infrared) respectively. The cluster head will have 9 visible laser diodes and 10 infrared diodes. This session will be given for 4 days a week, for 4 consecutive weeks. Intervention 2: Control group: The patients in this group will also receive the same treatment including TENS and LLLT but the laser unit will be switched off this time to get sham therapy. As the patient will be in prone lying with face turned downward and will be wearing protective goggles, so the participant will not be able to determine if the laser is turned off. 20-25 minutes of therapy session will be given in again in controlled group for 4 days a week, for 4 consecutive weeks. 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 further information.
public Shahzaib Anwer
4-B, Sadaat Street, Wahdat Colony,
Lahore Pakistan 54000 +92 42 35405234 shahzaibanwer33@gmail.com The University of Lahore scientific Shahzaib Anwer
4-B, Sadaat street, Ghazali Park, Wahdat colony,
Lahore Pakistan 54000 +92 42 35405234 shahzaibanwer33@gmail.com The University of Lahore Pakistan Both males and females Age ranging from 45 to 70 years Type II diabetes with clinical stage N2a of diabetic peripheral neuropathy Peripheral neuropathic symptoms lasting for ≥ 6 months 45 years 70 years Both Unstable glycemic index Pregnancy Some surgical cases such as knee replacement or any spinal surgery Spinal stenosis, spinal compression or any other relative radiculopathy Patients having malignancy and who have received radiotherapy treatment during last six months Peripheral vascular disease or Claudication Skin discoloration or skin ulcers E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified Treatment - Devices Placebo Intervention group: In experimental group, patients will receive 20-25 minutes of therapy session including 5 minutes of LLLT on lumbosacral area and plantar surface of foot each, along with the conventional therapy, including TENS for 15 minutes on lumbosacral area and plantar surface of foot having rectangular wave, 100µs pulse width, 150Hz frequency and 20mA intensity. TENS will be used on both sites at the same time. The 19 diode cluster head of the Laser 755 model will be used which have a wavelength of 640 nm (visible) and 950 nm (infrared) and a power of 10 mW (visible) and 15 mW (infrared) respectively. The cluster head will have 9 visible laser diodes and 10 infrared diodes. This session will be given for 4 days a week, for 4 consecutive weeks. Control group: The patients in this group will also receive the same treatment including TENS and LLLT but the laser unit will be switched off this time to get sham therapy. As the patient will be in prone lying with face turned downward and will be wearing protective goggles, so the participant will not be able to determine if the laser is turned off. 20-25 minutes of therapy session will be given in again in controlled group for 4 days a week, for 4 consecutive weeks. Pain. Timepoint: Before intervention, after 2 weeks and after 4 weeks of intervention. Method of measurement: Visual Analogue Scale for Pain. Numbness. Timepoint: Before intervention, after 2 weeks and after 4 weeks of intervention. Method of measurement: Michigan Neuropathy Screening Instrument (MNSI). The University of Lahore Teaching Hospital Approved 2021-11-15 Ethics committee of The University of Lahore 1-Km Defence Road, near Bhuptian Chowk, Lahore Punjab Pakistan