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IRCT20221101056358N1 IRCT 2022-11-21 Semnan University of Medical Sciences The Evaluation of adding tecar therapy effect on routine physiotherapy treatments compared to placebo tecar and routine physiotherapy treatments on pain, disability and electrical activity of erector spine muscles in patients with non-specific chronic low back pain The Evaluation of adding tecar therapy effect on routine physiotherapy treatments compared to placebo tecar and routine physiotherapy treatments on pain, disability and electrical activity of erector spine muscles in patients with non-specific chronic low back pain 2022-12-01 anticipated 32 Complete https://irct.ir/trial/66611 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: The sampling method in this research is done in the form of simple sampling. Allocation of samples (into two groups) is done randomly using the Stratified Permuted Block Randomization method with 5 blocks of 4 and 8 assigned to two groups 1 BBBAABAA 2 ABAB 3 AABBAABB 4 AABBBABA 5 AABB. Considering A as the routine physiotherapy treatment group and B as the exercise group, the methodologist randomly selects a number between 1 and 5 after each patient enters. The result of the lottery result of the corresponding block number is determined. In the next step, by referring to the above table, the type of intervention (whether it is A or B) is determined. For example, let's assume that the number 3 appears at some point in the lottery, by referring to block three, we can see that before AAB choices were made and now it is the turn to perform intervention B, then, the expert is asked for this patient exercise and Takar should be done together. In the image that the block number appeared in the lottery that all the previous options were completed, the lottery is completed again until the number of duplicate samples is completed, Blinding description: The main researcher will not divide the samples into two groups, and this work will be done by the research assistant who is a physiotherapy expert, and the information obtained from the data will be provided to the statistical evaluator in a coded and non-recognizable form. And the evaluator will not know about the grouping of people. Also, the intervention is done by another person, and the evaluation before and after the treatment is done by the main researcher, so this study is a thriple-blind one. N/A non-specific chronic low back pain. Intervention 1: The patients in the treatment group are treated for 5 sessions a week and a total of 10 sessions. 10 minutes of capacitive Tecar and 10 minutes of resistance Tecar are used. The frequency of the capacitive phase of the treatment is 600 KHZ and the frequency of the resistive phase of the treatment is 450 KHZ. Intensity in both types of treatment is 10-12 w or 0.42 j/cm2 for an area of ​​228.2 cm. The routine physiotherapy treatment is 10 sessions of TENS along with therapeutic exercises similar to the sessions of the treatment group and in each treatment session for 35 minutes (20 minutes Low-frequency TENS, with a frequency of 5 Hz and a pulse duration of 300 microseconds and the use of IR for 15 minutes on the lower back area), therapeutic exercise including lumbar pelvic stabilization exercises and paraspinal stretching. Intervention 2: Control group: Routine physiotherapy treatment, 10 sessions of TENS along with therapeutic exercises similar to the sessions of the treatment group and in each treatment session for 35 minutes (20 minutes of low frequency TENS, with a frequency of 5 Hz and pulse duration of 300 microseconds and use of IR for 15 minutes on the lower back area), therapeutic exercises include lumbar pelvic stabilization exercises and paraspinal stretching. Also, Tecar placebo is used. 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 uncertain variables that are included in intervention
public Morteza Heydari Nasir
East Sahib Al Zaman St. corner of Pakan Alley
Asadabad Iran (Islamic Republic of) 6541833586 +98 81 3311 7923 m.heydarinasir@gmail.com Semnan University of Medical Sciences scientific Morteza Heydari Nasir
East Sahib Al Zaman St. corner of Pakan Alley
Asadabad Iran (Islamic Republic of) 6541833586 +98 81 3311 7923 m.heydarinasir@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with symptoms of chronic back pain who are between 20 and 60 years old Diagnosis of chronic back pain for at least 12 weeks Visual pain index 4-7 Patients with back pain who have no documentation of discopathy or disc herniation 20 years 60 years Both Contraindication of tecar therapy: neoplasm, regional infection, patients with cardiac pacemaker and pregnancy. Active vertebral fracture previous spine surgery Rheumatoid diseases such as rheumatoid arthritis infectious diseases Systemic diseases that affect pain perception, such as diabetes and... Local injection such as (local anesthesia, corticosteroid...) Taking medicines and doing physiotherapy in the last 4 weeks M95-M99 Other disorders of the musculoskeletal system and connective tissue Rehabilitation Rehabilitation The patients in the treatment group are treated for 5 sessions a week and a total of 10 sessions. 10 minutes of capacitive Tecar and 10 minutes of resistance Tecar are used. The frequency of the capacitive phase of the treatment is 600 KHZ and the frequency of the resistive phase of the treatment is 450 KHZ. Intensity in both types of treatment is 10-12 w or 0.42 j/cm2 for an area of ​​228.2 cm. The routine physiotherapy treatment is 10 sessions of TENS along with therapeutic exercises similar to the sessions of the treatment group and in each treatment session for 35 minutes (20 minutes Low-frequency TENS, with a frequency of 5 Hz and a pulse duration of 300 microseconds and the use of IR for 15 minutes on the lower back area), therapeutic exercise including lumbar pelvic stabilization exercises and paraspinal stretching Control group: Routine physiotherapy treatment, 10 sessions of TENS along with therapeutic exercises similar to the sessions of the treatment group and in each treatment session for 35 minutes (20 minutes of low frequency TENS, with a frequency of 5 Hz and pulse duration of 300 microseconds and use of IR for 15 minutes on the lower back area), therapeutic exercises include lumbar pelvic stabilization exercises and paraspinal stretching. Also, Tecar placebo is used. Pain. Timepoint: Before the intervention and two weeks after the intervention and 1 month after the end of the last session of the intervention. Method of measurement: visual analogue scale- -. Functional disability. Timepoint: Before the intervention and two weeks after the intervention and 1 month after the end of the last session of the intervention. Method of measurement: Oswestry disability scale. Electrical activity of erector spine muscles. Timepoint: Before the intervention and two weeks after the intervention and 1 month after the end of the last session of the intervention. Method of measurement: Electromyographic device. Semnan University of Medical Sciences Approved 2022-10-31 Ethics committee of Semnan University of Medical Sciences East Sahib Al Zaman Street, corner of Pakan Alley, P7 asadabad Hamadan Iran (Islamic Republic of)