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IRCT20230502058050N1 IRCT 2023-05-22 Tehran University of Medical Sciences Investigating the Effect of Traditional Iranian Manual Technique on Pain and Disability in Patients with Chronic Low Back Pain Investigating the Effect of Traditional Iranian Manual Technique on Pain and Disability in Patients with Chronic Low Back Pain 2023-06-05 anticipated 108 Complete https://irct.ir/trial/69936 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The calculated sample size in each group is 54 people, which is 60 people in each group by calculating a ten percent loss, Randomization description: Using simple randomization with a table of random numbers to divide clients into two groups in the order of admission, Blinding description: By using a table of random numbers and inserting a random code on the paper inside the numbered envelopes, the patients are divided into two intervention and placebo groups (54 envelopes with even codes and 54 envelopes with odd codes are prepared). At the beginning of the intervention, the therapist chooses in which group (an even number or an odd number) to perform Iranian medicine manipulation and in which group to perform placebo manipulation (for example, if the code inside the envelope was an even number, the main manipulation will be performed on them, and in the case of an odd number, manipulation placebo will be done). The patient's name and surname are entered in a separate table along with the assigned code. In this way, the doctor treating the patient was not blinded, but the patient, the researcher, the author of the article, and the analyst of the results were blinded to the data. N/A Low Back Pain. Intervention 1: Intervention group: Iranian manual technique group, First, the patient lies on the examination bed in a supine position and both legs are placed together, and examinations such as: comparison of the length of the legs are performed (the distance between the two landmarks from the anterior superior iliac crest to the inner ankle in two side) and if this size is different, the person can be included in the study by considering other entry criteria. To perform the technique, the patient is placed on his side on the examination bed and the therapist holds the patient's chest and shoulder steady with one hand and puts pressure on the patient's back and pelvis with the other hand. The same technique is also performed lying on the opposite side. Intervention 2: Placebo group: Sham manipulation technique, In this group, the patient first lies on the examination bed in a supine position and both legs are placed together, and examinations such as: comparison of the length of the legs are performed (the distance between the two landmarks from the anterior superior iliac crest to the ankle internal on both sides) and if this size is different, the person can be included in the study considering other inclusion criteria. To perform the technique, the patient is placed on his side on the examination bed and slight pressure is applied on the iliac crest and tibia bone (bilaterally). Yes - There is a plan to make this available What will be shared: Information about its main outcomes can be shared. When: 6 months after the results are published To whom: All people Conditions: The data can be used for scientific analysis. Where to obtain: Our email: abbasian@sina.tums.ac.ir How to obtain: After viewing the resume and the reason for the request, it will be reviewed and sent within 3 months. Comments:
public Alireza Abbassian
No. 27, Taleghani Ave., North Sarparast St., Faculty of Persian Medicine
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4536 abbasian@sina.tums.ac.ir Tehran University of Medical Sciences scientific Alireza Abbassian
No. 27, Taleghani Ave., North Sarparast St., Faculty of Persian Medicine
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8897 4536 abbasian@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Personal and informed consent of the individual to participate in the research project Presence of chronic low back pain (history of more than three months of pain) Age range between 20 and 70 years old 20 years 70 years Both The presence of paresthesia and radicular pain and any specific pathology such as nerve root inflammation, spinal canal stenosis, spondylolysis, spondylolisthesis, vertebral fracture (clinical examination by a neurosurgeon to rule out any pathology) Non-mechanical back pain (wakes the patient up at night or causes pain and dryness in the morning) Fever, sweating and unexplained weight loss in the last few months Long-term corticosteroid therapy The symptoms of horse tail syndrome include numbness and weakness of both legs, pain in the anus, numbness of the perineum, paralysis of the sphincters. M54.5 Low back pain Treatment - Other Placebo Intervention group: Iranian manual technique group, First, the patient lies on the examination bed in a supine position and both legs are placed together, and examinations such as: comparison of the length of the legs are performed (the distance between the two landmarks from the anterior superior iliac crest to the inner ankle in two side) and if this size is different, the person can be included in the study by considering other entry criteria. To perform the technique, the patient is placed on his side on the examination bed and the therapist holds the patient's chest and shoulder steady with one hand and puts pressure on the patient's back and pelvis with the other hand. The same technique is also performed lying on the opposite side. Placebo group: Sham manipulation technique, In this group, the patient first lies on the examination bed in a supine position and both legs are placed together, and examinations such as: comparison of the length of the legs are performed (the distance between the two landmarks from the anterior superior iliac crest to the ankle internal on both sides) and if this size is different, the person can be included in the study considering other inclusion criteria. To perform the technique, the patient is placed on his side on the examination bed and slight pressure is applied on the iliac crest and tibia bone (bilaterally). Intensity of pain. Timepoint: Before and immediately after the intervention and one week after the intervention. Method of measurement: VAS questionnaire. Degree of disability. Timepoint: Before and one week after the intervention. Method of measurement: Roland Morris questionnaire. The number of diclofenac tablets taken. Timepoint: One week after the intervention. Method of measurement: Counting and averaging the number of pills taken daily. Tehran University of Medical Sciences Approved 2023-04-29 Ethics committee of Research School of Pharmaceutical Sciences, Tehran University of Medical Science Poursina Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences (TIPS) Tehran Tehran Iran (Islamic Republic of)