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IRCT20190315043058N3 IRCT 2024-03-29 Iran University of Medical Sciences The effect of sciatic nerve mobilization on pain, functional disability, sciatic nerve morphology and lower extremity muscles morphology in patients with lumbar radiculopathy due to disc herniation: A randomized controlled trial. The effect of sciatic nerve mobilization on pain, functional disability, sciatic nerve morphology and lower extremity muscles morphology in patients with lumbar radiculopathy due to disc herniation: A randomized controlled trial. 2024-04-20 anticipated 46 Complete https://irct.ir/trial/76115 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After completion of personal information and initial evaluations, patients with low back pain with radiculopathy symptoms will be randomly divided into two groups A or main treatment group: group B and control group receiving nerve mobilization placebo technique. Random allocation will be done in the variable block method, which consists of four-letter blocks made up of letters A and B. Then, the random list of treatments that will be obtained at the end of the assignment will be placed in the letters A and B in sealed and numbered envelopes (letter A represents nerve mobilization technique and the letter B represents the placebo technique of nerve mobilization). The random assignment process will be performed by an outside of the research team before the start of the study. After the initial evaluation by the examiner, the numbered envelopes will be presented to each person entering the study. Finally, after the patient enters the therapy sessions, the therapist will adjust the treatment interventions based on the letters in the envelope, Blinding description: Participants will be given envelopes in a closed envelope before the start of the first treatment session, and one of the letters A or B is written. Attendees deliver envelopes to their therapist, only the therapist is allowed to open the envelopes. The evaluator does not know the groups of participants. N/A patients with lumbar radiculopathy due to disc herniation. Intervention 1: Intervention group: Mobilization of the sciatica nerve (gliding). Intervention 2: Intervention group: Electrotherapy will consist of 20 minutes of conventional TENS (parameters include frequency 80-100 Hz; pulse width 50-100 microseconds; Flow Mode: Continuous; Patient Sense: Tingling within the patient's tolerance range). Intervention 3: Control group: Shame sciatic nerve mobilization techniques (nerve gliding). Intervention 4: Control group: Electrotherapy will consist of 20 minutes of conventional TENS (parameters include frequency 80-100 Hz; pulse width 50-100 microseconds; Flow Mode: Continuous; Patient Sense: Tingling within the patient's tolerance range). 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 No more information
public Dr. Esmaeel Ebrahimi Takamjani
Shahnazari Ave., Mirdamad Blvd., Tehran Town
Tehran Iran (Islamic Republic of) 1998135353 +98 21 2239 2426 ebrahimitakamjani.e@iums.ac.ir Iran University of Medical Sciences scientific Maryam Ahmadi
Shahnazari Ave., Mirdamad Blvd., Tehran Town
Tehran Iran (Islamic Republic of) 1998135353 +98 21 2239 2426 maryamahmadima226@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 46 patients with radiculopathy in one leg for at least 3 months (having at least one of the symptoms: pain, numbness, tingling) Age between 18-55 Positive SLR test at an angle of 20 to 70 degrees Pain score based on the NPRS scale in the lower back should be more than 40 and less than 60 during the last 24 hours at rest. BMI<30 Confirmation of disc bluging using MRI at levels of L4-L5 and L5-S1. Having a minimum reading and writing literacy (cycle) to fill out questionnaires. 18 years 55 years Both Absence of any underlying disease, including diabetes, previous problems, etc. Any dissatisfaction and lack of participation of patients during the course of treatment. Low back pain due to rheumatoid arthritis, inflammation of the spine joints, infection, spondylolisthesis, fracture, trauma, osteoporosis, etc. pregnancy Physical therapy at least 1 month ago Any disease during the course of treatment that interferes with the research process. Injury to the limbs or back area during the course of treatment. Absence of more than 2 sessions during the course of treatment. Treatment - Other Treatment - Other Placebo Treatment - Other Intervention group: Mobilization of the sciatica nerve (gliding) Intervention group: Electrotherapy will consist of 20 minutes of conventional TENS (parameters include frequency 80-100 Hz; pulse width 50-100 microseconds; Flow Mode: Continuous; Patient Sense: Tingling within the patient's tolerance range). Control group: Shame sciatic nerve mobilization techniques (nerve gliding) Control group: Electrotherapy will consist of 20 minutes of conventional TENS (parameters include frequency 80-100 Hz; pulse width 50-100 microseconds; Flow Mode: Continuous; Patient Sense: Tingling within the patient's tolerance range). Pain. Timepoint: Measurement of pain is done at the beginning of the study (before the intervention) and the last treatment period. Method of measurement: Numeric pain rating scale (Moderate back pain in the last 24 hours at rest). Functional disability. Timepoint: Measurement of pain is done at the beginning of the study (before the intervention) and the last treatment period. Method of measurement: Persian version of Oswestery disability index. Straight leg raise Angle. Timepoint: Measurement of pain is done at the beginning of the study (before the intervention) and the last treatment period. Method of measurement: Goniometer. Changes in Sciatic Nerve Morphology. Timepoint: At the beginning of the study (before the intervention) and immediately after the last treatment session. Method of measurement: Ultrasonography devices. Morphological Changes in Lower Extremity Muscles. Timepoint: At the beginning of the study (before the intervention) and immediately after the last treatment session. Method of measurement: Ultrasonography devices. Iran University of Medical Sciences Approved 2024-03-11 Ethics committee of Iran university of medical sciences Hemmat Highway., next to Milad Tower Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)