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IRCT20220410054486N1 IRCT 2022-06-23 Iran University of Medical Sciences The effect of high power laser therapy on radicular low back pain The effect of high power laser therapy on pain, functional disability, range of motion and pressure pain threshold in subjects with radicular low back pain due to intervertebral disc herniation 2022-07-11 anticipated 36 Complete https://irct.ir/trial/62860 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible patients with chronic radicular low back pain are randomly divided into two groups of treatment: high-intensity laser therapy and placebo high-intensity laser therapy groups with a 1: 1 ratio. Generatorslist.com is used to determine random allocation; This method is done with the help of four-digit blocks including even and odd numbers. For this purpose, 4-digit numbers are selected that have 2 even digits and 2 odd digits; Each digit represents each participant in the study. The random allocation process will be performed by someone outside the research team before the study begins. At the end of the random allocation, the numbers will be placed inside the numbered envelopes separately and after the initial evaluation by the examiner, the numbered envelopes will be given according to the ordinal number of each person entered in the study. Finally, after each participant enters the treatment sessions, the therapist opens the envelope of the participants and applies therapeutic interventions based on the number in the envelope. Patients are told not to provide information about their group to the assessor to prevent data contamination, Blinding description: In this study, patients and assessor of outcomes are blind to treatment groups. First, the assessor measures the outcomes and then includes the study and the therapist performs the treatments of both groups, the assessor is not aware of the type of treatment during the study. Patients are first informed with a full explanation that the study is a clinical trial and has two groups and they will be in the intervention group or the control group, randomly. All patients wear a protective blindfold during treatment (due to laser treatment); To create real therapeutic conditions for the placebo group; The patient lies prone with a pillow under his abdomen and wears a protective blindfold. The difference is that the laser is off and an audio player turns on the sound of the laser device, to simulate the situation. At the end of the study, the examiner performs the final evaluation. N/A Radicular low back pain. Intervention 1: Intervention group: high-intensity laser therapy as the patient sleeps prone and a pillow will be placed under the abdomen and he wears a protective blindfold, the laser scanner is placed at a distance of 50 cm from the skin and the area under the 12th ribs to the upper part of the iliac crest from 4.2 cm outside the spine spinous process. Also, the sciatic, tibial and peroneal nerve pathways are laser irradiated. GaAlAs laser device with an average power of 1.6 watts and a wavelength of 808nm. The duty cycle is 80%. At the beginning of treatment with 10 joules per square centimeter and according to the patient's subjective symptoms, after every 3 sessions, 2 joules will be added to the previous dose; The final indication for a therapeutic dose is 16 joules per square centimeter and the treatment of motor control exercises is the basic treatment for all patients: The transverse abdominis and multifidus contractions will be done separately and also will be done as co-contractions in various positions. Contractions are initially performed up to a maximum of 10 repetitions per movement. Hold the contraction for 10 seconds. From the third week, the patient should be able to easily perform 10 repetitions and hold the contraction for 10 seconds and increase it. So, the exercises are progressive. Correction of activities including how to sleep, sit and stand properly, and how to carry loads are taught to the patient. Intervention 2: Control group: Unrealistic high-power laser as the patient lies prone with a pillow under his abdomen and wears a protective blindfold. The difference is that the laser is off and an audio player turns on the sound of the device to simulate the situation and the treatment of motor control exercises is the basic treatment for all patients: The transverse abdominis and multifidus contractions will be done separately and also will be done as co-contractions in various positions. Contractions are initially performed up to a maximum of 10 repetitions per movement. Hold the contraction for 10 seconds. From the third week, the patient should be able to easily perform 10 repetitions and hold the contraction for 10 seconds and increase it. As a result, the exercises are progressive. Correction of activities including how to sleep, sit and stand properly, and how to carry loads are taught to the patient. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary. When: Starting 6 months after publication To whom: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders Conditions: The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Where to obtain: Applicants can contact Dr. Mohammad Reza Pourahmadi (PT, PhD) by email. Email address: pourahmadipt@gmail.com How to obtain: Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days. Comments:
public Mohammad Reza Pourahmadi
Department of Physiotherapy, Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 4391-15875 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences scientific Mohammad Reza Pourahmadi
Department of Physiotherapy, Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 4391-15875 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Age between 25-60 years Diagnosis of radicular low back pain from the origin of the intervertebral disc herniation of the fourth lumbar to the first sacral vertebra by a neurosurgeon At least 12 weeks have passed since the symptoms Persistent pain or paraesthesia (numbness and/or tingling) in the lower back or both limbs due to herniation of the lumbar intervertebral disc in the path of the nerve root dermatome Patients on MRI stereotypes have protrusion or extrusion disc herniation 25 years 60 years Both Local or systemic infection, rheumatic disease, diabetes Vertebral and sacroiliac joint dysfunction (Gillette test positive) Pregnancy History of previous surgery in the area Patients with MRI of spinal canal stenosis or spondylolisthesis Patients with vascular disorders, cancer and tumors and synovial cysts History of physiotherapy for at least the last 12 weeks sciatic nerve Contusion psychiatric illnesses Active trigger point of gluteus minimus muscle (diffuse sciatica-like pain) M54.17 Radiculopathy, lumbosacral region Rehabilitation Rehabilitation Intervention group: high-intensity laser therapy as the patient sleeps prone and a pillow will be placed under the abdomen and he wears a protective blindfold, the laser scanner is placed at a distance of 50 cm from the skin and the area under the 12th ribs to the upper part of the iliac crest from 4.2 cm outside the spine spinous process. Also, the sciatic, tibial and peroneal nerve pathways are laser irradiated. GaAlAs laser device with an average power of 1.6 watts and a wavelength of 808nm. The duty cycle is 80%. At the beginning of treatment with 10 joules per square centimeter and according to the patient's subjective symptoms, after every 3 sessions, 2 joules will be added to the previous dose; The final indication for a therapeutic dose is 16 joules per square centimeter and the treatment of motor control exercises is the basic treatment for all patients: The transverse abdominis and multifidus contractions will be done separately and also will be done as co-contractions in various positions. Contractions are initially performed up to a maximum of 10 repetitions per movement. Hold the contraction for 10 seconds. From the third week, the patient should be able to easily perform 10 repetitions and hold the contraction for 10 seconds and increase it. So, the exercises are progressive. Correction of activities including how to sleep, sit and stand properly, and how to carry loads are taught to the patient. Control group: Unrealistic high-power laser as the patient lies prone with a pillow under his abdomen and wears a protective blindfold. The difference is that the laser is off and an audio player turns on the sound of the device to simulate the situation and the treatment of motor control exercises is the basic treatment for all patients: The transverse abdominis and multifidus contractions will be done separately and also will be done as co-contractions in various positions. Contractions are initially performed up to a maximum of 10 repetitions per movement. Hold the contraction for 10 seconds. From the third week, the patient should be able to easily perform 10 repetitions and hold the contraction for 10 seconds and increase it. As a result, the exercises are progressive. Correction of activities including how to sleep, sit and stand properly, and how to carry loads are taught to the patient. Visual analog scale (VAS): Rated zero (painless) to 10 (most severe imaginable pain) of lumbar. Timepoint: The visual analog scale of pain is measured by the assessor before the intervention and every three sessions until the end of treatment, and one month after the end of treatment. Method of measurement: In this study, pain is determined on a visual analog scale with a score of zero (painless) to 10 (the most severe pain imaginable for patients). The average pain in the last 7 days is the number of VAS. Functional disability. Timepoint: Before the start of treatment by the assessor and the end of treatment and one month after the end of treatment. Method of measurement: In this study, the functional disability of the score obtained from the localized and Persianized Oswestry questionnaire, which was validated by Mousavi et al. In 2006. Pressure pain threshold. Timepoint: Before the start of treatment by the assessor and the end of treatment and one month after the end of treatment. Method of measurement: In this study, an algorithm will be used to measure the pressure threshold of pain. The algometer will record each point three times and an average of numbers per point will be written finally. 2 and 5 cm outside the first lumbar vertebra, 2 and 5 cm outside of the third lumbar vertebra,2 cm outside of the fifth lumbar vertebra bilaterally, on the common peroneal nerve (which comes from behind the fibula bone and reaches the front of the neck bone) and tibial nerve (outside the tibial artery) and the sciatic nerve (between the ischial tuberosity and the large trochanter deep in the gluteus maximus muscle), obtained at the moment of pain onset by participants, by algometer, in Newtons per square centimeter. Range of motion. Timepoint: Before the start of treatment by the assessor and the end of treatment and one month after the end of treatment. Method of measurement: In this study, the range of motion is the active movement of the lumbar region forward (using Schubert test) and the SLR range of motion of the affected lower limb (using a goniometer). Iran University of Medical Sciences Approved 2022-05-09 Ethics committe of Iran University of Medical Science Maddakaran Alley, Shah Nazari St., Madar Square Tehran Tehran Iran (Islamic Republic of)