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IRCT20210316050727N1 IRCT 2021-07-06 Tabriz University of Medical Sciences Effects of interferential therapy on electroencephalography of patients with chronic nonspecific low back pain Effects of one session interferential therapy on electroencephalography of patients with chronic nonspecific low back pain: A Randomized Controlled Trial 2021-05-05 anticipated 40 Complete https://irct.ir/trial/55084 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Random software allocation For the allocation concealment, the type of intervention received is written on a piece of paper and placed inside the opaque envelopes and the back of the envelope will be numbered. The envelopes will be opened according to the entry of the participants and the type of group for each patient will be specified accordingly, Blinding description: Participants: Individuals are unaware of the groupings and the group to which they belong and there is no exchange of information between participants. Data Analyzer: The collected information is provided to the analyzer without mentioning the groupings and patient information. N/A chronic nonspecific low back pain. Intervention 1: Intervention group 1: In the intervention group, participants will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with intensity at the level of sensory stimulation in the lumbar region. The intensity of the current increases until the patient has a strong tingling sensation and at the same time comfort, and the intensity of the current will increase every 5 minutes. Intervention 2: Intervention group 2: placebo group, In the placebo group, patients will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with ineffective intensity so that the current intensity does not reach the target point and every 5 minutes without increasing the current intensity, the patient's comfort will be questioned. Intervention 3: Control group: Healthy people participating in the study will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with intensity at the level of sensory stimulation in the lumbar region. The intensity of the current increases until the patient has a strong tingling sensation and at the same time comfort, and the intensity of the current will increase every 5 minutes. 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 Abas Soltani someh
Rehabilitation Faculty, Daneshgah avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3337 5359 ab.soltani@yahoo.com Tabriz University of Medical Sciences scientific Abas Soltani someh
Rehabilitation Faculty, Daneshgah avenue, Tabriz
Tabriz Iran (Islamic Republic of) 5167631444 +98 41 3337 5359 ab.soltani@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Low back pain with or without pain radiating to the lower extremities above the knee for more than three months Pain perception over 40 mm in the Visual Analogue Scale 20 years 65 years Both Existence of any serious disorders in the spine such as fractures, tumors, inflammatory diseases Nerve root disorders confirmed by neurological testing Having simultaneous treatment Cancer patients and heart patients with pacemakers Any contraindicationto the use of electrotherapy Having received physiotherapy treatment in the eight weeks before data collection Having metal implants in the spine Pregnancy Taking drugs that affect the nervous system History of neuropsychological diseases Corticosteroid treatment in the last 2 weeks sleep disorder M54.5 Low back pain Treatment - Other Placebo N/A Intervention group 1: In the intervention group, participants will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with intensity at the level of sensory stimulation in the lumbar region. The intensity of the current increases until the patient has a strong tingling sensation and at the same time comfort, and the intensity of the current will increase every 5 minutes. Intervention group 2: placebo group, In the placebo group, patients will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with ineffective intensity so that the current intensity does not reach the target point and every 5 minutes without increasing the current intensity, the patient's comfort will be questioned. Control group: Healthy people participating in the study will receive one session interferential current for 30 minutes with a carrying frequency of 4 kHz and a bit frequency of 100 Hz with intensity at the level of sensory stimulation in the lumbar region. The intensity of the current increases until the patient has a strong tingling sensation and at the same time comfort, and the intensity of the current will increase every 5 minutes. Theta wave power( Absolute power of the frequency range 4-7 Hz). Timepoint: Before and after the intervention. Method of measurement: EEG recorder. Alpha wave power( Absolute power of the frequency range 8-12 Hz). Timepoint: Before and after the intervention. Method of measurement: EEG recorder. Beta wave power( Absolute power of the frequency range 13-30 Hz). Timepoint: Before and after the intervention. Method of measurement: Absolute power of the frequency range 13-30 Hz. Gamma wave power( Absolute power of frequency range above 30 Hz). Timepoint: Before and after the intervention. Method of measurement: EEG recorder. Intensity of pain( VAS scale score). Timepoint: Before and after the intervention. Method of measurement: VAS scale. Tabriz University of Medical Sciences Approved 2021-02-14 Ethics committee of Tabriz University of Medical Sciences Rehabilitation faculty, Daneshgah avenue, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)