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IRCT20180721040539N2 IRCT 2020-12-08 Babol University of Medical Sciences The Effects of High Intensity Laser on Clinical and Electrophysiological Findings of Unilateral Cervical Radiculopathy Due to Disc Protrusion The Effects of High Intensity Laser on Clinical and Electrophysiological Findings of Unilateral Cervical Radiculopathy Due to Disc Protrusion؛ A Triple Blind Randomized Clinical Trial Study 2020-12-21 anticipated 30 Complete https://irct.ir/trial/51588 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomized into one of the intervention groups. The simple randomization method will be used; Randomization list will be generated by a computer program (Excel Office 2010) by a statistician and performed by a participating researcher not involved with the recruitment or evaluation of patients. This same researcher will be responsible for programming the HIL device according to the result of the randomization. The HIL device used in the present study will make the same sounds regardless of the programmed dose and mode (active HIL or placebo HIL). This researcher will not disclose the programmed intervention (active HIL or placebo HIL) to the therapist or any of the patients and other researchers involved in the study until its final completion. Concealed allocation will be achieved through the use of sequentially numbered, sealed and opaque envelopes, Blinding description: Initially the patients will be visited by the first study's blinded assessor (neurology specialist) who will determine eligible participants based on inclusion and exclusion criteria and will obtain the electrophysiological outcomes. Next, the second study's blinded assessor (physiotherapy specialist) will collect the clinical outcomes. Then all eligible patients will be randomized and allocated into two treatment groups (active HIL or placebo HIL) by a researcher who is not involved with the recruitment or evaluation of patients. This same researcher is the only person that aware of patients allocation to their treatment groups and will be responsible for programming the HIL device according to the result of the randomization. This researcher will not disclose the programmed intervention to the therapist or any of the patients and other researchers involved in the study until its final completion; Thus Patients, therapist and assessors will be blinded throughout the study. Assessment of clinical and electrophysiological outcomes at the end of the 10 treatment sessions and 1month follow-up will be performed by the same assessors who carried out the first evaluations. Eventually, collected data will be analyzed by a statistician. 2 Unilateral cervical radiculopathy due to disc protrusion. Intervention 1: Active HIL group: HIL will be applied using the Delta Laser New Age device (Italy) with a wavelength of 980 nm and 13 W maximum power output with probe diameter of 1 cm. The treatment will be consisted of three phases in each session. The initial phase will involve a peak power of 13 W, average power of 6/5 W and 1852 J energy.The intermediate phase will be applied a peak power of 11 W, average power of 5/5 W and 1574 J energy. The final phase will be performed with a peak power of 13 W, average power of 6/5 W and 1852 J energy the same as the initial phase. HIL treatment will be included 15 min application time (each phase 5 min), duty cycle of 50% (in all 3 phases) and total energy of 5278 J in each session. Probe will be held in contact with the dry skin previously cleaned with alcohol, at 90 degree angle perpendicular to the paraspinal muscles above the transverse processes of each of the cervical and upper thoracic vertebrae in affected side which will be consisted 30 cm2 treatment area. The hand piece will be moved in a parallel slow motion to the intended muscle fibers. Intervention 2: Placebo HIL Group: The placebo HIL will be applied on the same irradiated sites in the active HIL group using the same device that activates HIL but without any emission of therapeutic dose. Thus patients will receive a total dose of 0 J in placebo mode. The active and placebo HIL procedures will be performed in the prone position with slightly flexion in cervical spine and also laser protective goggles will be used in both groups. To ensure blinding for therapist and patients, the device will emit the same sounds regardless of the programmed mode (active or placebo). Furthermore, because the device produces a non-significant amount of heat, the patients will not be able to know if active or placebo HIL will be administered. The device was previously coded as active or placebo modes, and only one researcher not involved in the evaluation and treatment is aware of these codes. Patients will undergo treatment (active HIL or placebo) according to prior randomization, three times a week on even days, for 10 sessions totally. Ultrasound and TENS therapy will be done similarly in both groups. Ultrasound therapy will be performed in prone position by the apparatus Novin 215P (Iran), frequency of 1 MHz, intensity of 1/5 w/cm, duty cycle of 50% and treatment time of 5 minutes. Surface of US probe covered with conductivity gel will be moved on the cervical paraspinal muscles in affected side with the slow circular movements. TENS application will be applied in supine position by the stimulator device Novin 735X (Iran) in conventional mode for 20 min at 70-Hz frequency and 100-μs wavelength. Four 4×6 electrodes stimulator device will be placed in a standardized dermatomal pain pattern. The intensity of the electrical stimulation will be adjusted to the maximum tolerated amplitude without producing muscle contractions. 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 I have not decided yet
public Pardis norouzi
In front of Shaolin gym, Shahid nikpey Alley, Kashef sharghi Ave
Lahijan Iran (Islamic Republic of) 44168-77797 +98 13 4222 3382 pardis.norouzi.pt@gmail.com Babol University of Medical Sciences scientific Seyyede roghayeh mousavi khatir
Ganjafrouz Ave, Babol university of medical science
Babol Iran (Islamic Republic of) 44176-47745 00981132199592-5 r-mousavi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Aged 20-55 years Neck pain visual analogue score of 3-7 Radicular pain and/or paresthesia in affected upper limb C5-C6، C6-C7 ،C7-C8 and C8-T1 disc protrusion confirmed by MRI Diagnosed unilateral cervical radiculopathy due to disc protrusion by a neurology specialist based on nerve conduction study (NCS) and electromyography (EMG) Symptoms lasting for at least 3 months Positive Spurling compression test Positive Median nerve tension test 20 years 55 years Both Inflammatory diseases such as rheumatoid arthritis Viral, fungal, and bacterial infections Systemic and metabolic diseases History of neck surgery Abnormal laboratory findings Psychiatric illnesses Photosensitive diseases Trauma and fracture in cervical spine Fibromyalgia Active cancer or a cancer history of less than 1 year after the end of treatment Epilepsy Upper limb peripheral nerves entrapment syndromes Tumor Muscle weakness Loss of reflex Cervical disc extrusion and sequestration Atrophy Metal implants Skin lesions in the treatment area Pregnancy Degenerative changes of cervical or thoracic region Cardiovascular failure Pacemaker Decreased motor nerves amplitude in electrophysiological findings Rehabilitation Rehabilitation Active HIL group: HIL will be applied using the Delta Laser New Age device (Italy) with a wavelength of 980 nm and 13 W maximum power output with probe diameter of 1 cm. The treatment will be consisted of three phases in each session. The initial phase will involve a peak power of 13 W, average power of 6/5 W and 1852 J energy.The intermediate phase will be applied a peak power of 11 W, average power of 5/5 W and 1574 J energy. The final phase will be performed with a peak power of 13 W, average power of 6/5 W and 1852 J energy the same as the initial phase. HIL treatment will be included 15 min application time (each phase 5 min), duty cycle of 50% (in all 3 phases) and total energy of 5278 J in each session. Probe will be held in contact with the dry skin previously cleaned with alcohol, at 90 degree angle perpendicular to the paraspinal muscles above the transverse processes of each of the cervical and upper thoracic vertebrae in affected side which will be consisted 30 cm2 treatment area. The hand piece will be moved in a parallel slow motion to the intended muscle fibers. Placebo HIL Group: The placebo HIL will be applied on the same irradiated sites in the active HIL group using the same device that activates HIL but without any emission of therapeutic dose. Thus patients will receive a total dose of 0 J in placebo mode. The active and placebo HIL procedures will be performed in the prone position with slightly flexion in cervical spine and also laser protective goggles will be used in both groups. To ensure blinding for therapist and patients, the device will emit the same sounds regardless of the programmed mode (active or placebo). Furthermore, because the device produces a non-significant amount of heat, the patients will not be able to know if active or placebo HIL will be administered. The device was previously coded as active or placebo modes, and only one researcher not involved in the evaluation and treatment is aware of these codes. Patients will undergo treatment (active HIL or placebo) according to prior randomization, three times a week on even days, for 10 sessions totally. Ultrasound and TENS therapy will be done similarly in both groups. Ultrasound therapy will be performed in prone position by the apparatus Novin 215P (Iran), frequency of 1 MHz, intensity of 1/5 w/cm, duty cycle of 50% and treatment time of 5 minutes. Surface of US probe covered with conductivity gel will be moved on the cervical paraspinal muscles in affected side with the slow circular movements. TENS application will be applied in supine position by the stimulator device Novin 735X (Iran) in conventional mode for 20 min at 70-Hz frequency and 100-μs wavelength. Four 4×6 electrodes stimulator device will be placed in a standardized dermatomal pain pattern. The intensity of the electrical stimulation will be adjusted to the maximum tolerated amplitude without producing muscle contractions. Pain. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Visual Analog Scale. Radicular pain and/or paresthesia in affected upper limb. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Short-Form McGill pain questionnaire (SF-MPQ-2). Functional disability. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Neck disability index questionnaire. Neck active range of motion including flexion, extension, lateral flexion (both sides), rotation (both sides). Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Median nerve tension. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Median nerve tension test. Electrophysiological parameters including motor distal latency, motor nerve conduction velocity and F-wave of radial, ulnar, median motor nerves. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Electrodiagnosis device Negarandishegan-EMG/NCV/EP400S. Babol University of Medical Sciences Approved 2020-09-19 Ethics committee of Babol University of Medical Sciences Babol university of medical science, Ganjafrouz Ave Babol Mazandaran Iran (Islamic Republic of)