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IRCT20230205057336N2 IRCT 2023-09-27 Shiraz University of Medical Sciences Investigating the effect of dry needling compared to sham dry needling on the sensitization of the nervous system at peripheral, spinal and cerebral levels in patients with Non-specific Chronic Low Back Pain(NSCLBP) Investigating the effect of dry needling compared to sham dry needling on the sensitization of the nervous system at peripheral, spinal and cerebral levels in patients with Non-specific Chronic Low Back Pain(NSCLBP) 2023-10-01 anticipated 56 Complete https://irct.ir/trial/72616 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned to intervention and sham groups by permutation randomization method which is done with the help of randomization program (block number 14 and block size 4). Allocation of samples is done in a ratio of 1:1. In order to hide the allocation, opaque and sealed envelopes are used, Blinding description: In order to blind the study, evaluation tests are performed by one physiotherapist and dry needling treatment techniques are performed by another physiotherapist. Statistical analysis is performed by a person who does not know the grouping of patients. On the other hand, the participants do not know about the group they are randomly placed in. N/A Non-specific Chronic Low Back Pain. Intervention 1: Intervention group: Patients in this group receives three treatment sessions with an interval of 72 hours. In the range of minimum 3 to maximum 7 muscles from lumbar multifidus muscles, gluteus maximus, gluteus medius, quadratus lumbarum and paravertebral muscles, which is considered as paravertebral muscle, lumbar iliocostalis muscle. All muscles are selected and dry needled based on the number of active trigger points they have. In this dry needling study, the fast in-fast out technique is used. We manipulate the needle in different directions until the first twitch is seen. The size of the needles is selected according to the volume of fat tissue in the patient's body. In cases where it is necessary, strong pressure is applied to compress the skin tissue. Intervention 2: Control group: Control group: the needle is taken out of the box without tearing its packaging, and its tip is shortened enough that it no longer touches the patient's skin and is placed back in the packaging. The patient is placed exactly like the treatment group for all muscles and an alcohol pad is used. In this treatment, the guide is pressed on the patient's body to create a sensation similar to dry needling. Other interventions will be completely similar to the intervention group. 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 After preparing and completing the files, they will be available to the readers or other scientific people if needed
public Narges Meftahi
Abiverdi st1, Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 meftahin@sums.ac.ir Shiraz University of Medical Sciences scientific Narges meftahi
Abiverdi st 1, Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 meftahin@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) At least three months have passed since the onset of their back pain Have an average age of 18-45 years There are no signs of involvement of nerve roots, disc inflammation and sciatic nerve Have at least 3 to a maximum of 7 active trigger points in the gluteus maximus, gluteus medius, quadratus lumbarum, paravertebral and multifidus muscles The score of the CSI questionnaire is equal to or greater than 40 Numerical evaluation of pain should have at least score of 3 No previous history of dry needling treatment 18 years 45 years Both History of hemophilia and coagulation disorders A patient with lymphedema Pregnancy Cancer, fracture, infection or immunodeficiency diseases such as AIDS and hepatitis Specific back pains including back pains originating from disc involvement and nerve roots, spondylolisthesis and spondylolysis A patient with back pain that is the origin of visceral pain Use of anticoagulants Patients with fear of needles in the form of phobia Treatment - Other Placebo Intervention group: Patients in this group receives three treatment sessions with an interval of 72 hours. In the range of minimum 3 to maximum 7 muscles from lumbar multifidus muscles, gluteus maximus, gluteus medius, quadratus lumbarum and paravertebral muscles, which is considered as paravertebral muscle, lumbar iliocostalis muscle. All muscles are selected and dry needled based on the number of active trigger points they have. In this dry needling study, the fast in-fast out technique is used. We manipulate the needle in different directions until the first twitch is seen. The size of the needles is selected according to the volume of fat tissue in the patient's body. In cases where it is necessary, strong pressure is applied to compress the skin tissue. Control group: Control group: the needle is taken out of the box without tearing its packaging, and its tip is shortened enough that it no longer touches the patient's skin and is placed back in the packaging. The patient is placed exactly like the treatment group for all muscles and an alcohol pad is used. In this treatment, the guide is pressed on the patient's body to create a sensation similar to dry needling. Other interventions will be completely similar to the intervention group. Conditioned pain modulation. Timepoint: Before, immediately and six weeks after the intervention. Method of measurement: The difference in pressure pain tolerance threshold with algometer before and after the application of conditioned pain by pressure cuff. Temporal summation of pain. Timepoint: Before, immediately and six weeks after the intervention. Method of measurement: The difference in pain report based on numeric rate scale after one stimulation and several repeated painful stimulations. Pressure pain threshold both in the pain area and in the distal area. Timepoint: Before, immediately and six weeks after the intervention. Method of measurement: Record the number shown on the algometer display at the moment of pain after applying pressure. Central sensitization. Timepoint: Before, immediately and six weeks after the intervention. Method of measurement: Central sensitization inventory. Pain. Timepoint: Before, immediately and six weeks after the intervention. Method of measurement: Numeric rate scale. Function rate. Timepoint: Before, immediately and six weeks after the intervention. Method of measurement: Extensor muscle endurance test. Shiraz University of medical sciences Approved 2023-07-26 Ethics Committee in Shiraz Faculty of Rehabilitation Science research Abiverdi st 1, Chamran Blvd Shiraz Fars Iran (Islamic Republic of)