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IRCT20240916063057N1 IRCT 2024-10-20 University of social welfare and rehabilitation sciences the effect of education in treatment of chronic low back pain The effect of adding pain neuroscience education on the clinical results of core muscle training using pressure biofeedback in people with chronic low back pain diagnosed with functional instability 2024-11-17 anticipated 48 Complete https://irct.ir/trial/79217 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: People referring to the Physiotherapy Department of ROFAYDEH Hospital, Department of Low Back Pain School are first examined by the senior researcher (NOT BLIND) according to the Inclusion criteria. If they meet the Inclusion criteria, they are included in the study.) Using the www.sealed envelope.com website with a block size of 4 (block size n=4) a random sequence is made Then, one of the 6 modes AABB, ABAB, ABBA, BBAA, BABA, BAAB will be randomly selected, where A represents the first group and B represents the second group. Then the blind assessor seals using non-transparent envelopes the random sequences generated by the site are placed in envelopes for every 48 people, and people take one of the 48 envelopes without putting them in the order of arrival and enter the study, Blinding description: Therapist doesn't blind to type of treatment and assessment and both groups Assessor blind to type of treatment and assessment and both groups Patient don't blind to type of treatment and groups Statistics analyzer blind to treatment and assessment and both groups. N/A chronic low back pain diagnosed with functional instability. Intervention 1: Intervention group: core muscle training using pressure biofeedback device along with pain neuroscience education. Intervention 2: Control group: core muscle training using pressure biofeedback device. Yes - There is a plan to make this available What will be shared: All ethical forms and documents and informed consent in the process of receiving the code of ethics are registered in the proposal When: 8 months after the publication of the results of the thesis and the publication of the article extracted from the thesis To whom: Senior Researcher (Golnaz Sadria) Ethics Committee of the University of social welfare and Rehabilitation Sciences Conditions: It can be retrieved only if the patient's physical condition becomes problematic and for a detailed examination of the information and the treatment process Where to obtain: In order to receive the results of the research, the contact numbers of the patients and their communication channels are included in the informed consent form, and after the review and analysis of the data by the senior researcher, the results will be provided to the participants via email or face-to-face meeting. How to obtain: First, according to the informed consent form, in which the number of the senior researcher (Golnaz Sadria) is mentioned, contact is made with that number, then after explaining the reason for receiving the documents to the senior researcher and presenting it to the ethics committee of the University of social welfare and rehabilitation science, information After unlocking, the code will be provided to the participant. Comments:
public Golnaz Sadria
kodakyar Ave., daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 gl.sdr9019@gmail.com University of social welfare and rehabilitation sciences scientific Golnaz Sadria
kodakyar Ave., daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 gl.sdr9019@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) age range 18-40 at least education level is diploma prone instability test is positive Gower’s sign is positive at least 3 month patient have continuous pain in lumbago there is no obvious symptom in lumbar region ( patients rule out when have these disorder: decrease sensation in specific dermatome , decrease strength in specific myotome of lumbar region , disc herniation ,sacroiliac joint dysfunction ) at least patient have 3times low back pain during last year intensity of patient's pain during Gower’s test in Visual Analogous Scale should be 3to7 Oswestry disability index more than 12% patient can stand and walk without any supportive aid such as cane patient don't have Rheumatoid and central nervous system disorder patient don't have any history of tumor, malignancy and spinal malposture patient don't have any history of abdominal surgery at least score of MMSE for measuring cognition state should be 27 BMI not more than 30 patient don't get any medications and exercise therapy during last 3 month 18 years 40 years Both pregnancy sitting more than 2 hours a day Rehabilitation Rehabilitation Intervention group: core muscle training using pressure biofeedback device along with pain neuroscience education Control group: core muscle training using pressure biofeedback device Pain. Timepoint: pre treatment,immediate after fifteen session,Three months after the end of treatment. Method of measurement: visual analogous scale. Disability. Timepoint: pre treatment, immediate after fifteen sessions , Three months after the end of treatment. Method of measurement: Oswestry disability index. Fear of movement. Timepoint: pre treatment, immediate after fifteen sessions , Three months after the end of treatment. Method of measurement: tampa scale. Thickness of transverse abdominis muscle. Timepoint: pre treatment, immediate after fifteen sessions , Three months after the end of treatment. Method of measurement: sonography. Brain wave. Timepoint: pre treatment, immediate after fifteen sessions , Three months after the end of treatment. Method of measurement: neurofeedback. University of social welfare and rehabilitation sciences Approved 2024-09-28 Ethics committee of social welfare and rehabilitation science Koodakyar End, Shahid Shahriari Square,Evin Tehran Tehran Iran (Islamic Republic of)