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IRCT20201108049305N1 IRCT 2020-12-13 Esfahan University of Medical Sciences Effect of Psoas myofascial release in nonspecific low back pain Comparison between the effect of routine physiotherapy and routine physiotherapy with Psoas muscle direct myofascial release technique on pain and disability index in patient with chronic nonspecific low back pain 2020-11-20 anticipated 40 Complete https://irct.ir/trial/52220 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study simple randomization is used. For generating random sequence, table of random numbers generated by Start Trek website is used, there are 40 numbers in this table which are coding from 01 to 40. After writing the numbers by the researcher, she will read the randomized number from left to right, so the first 20 codes will be in the control group and the second 20 codes will be in the intervention group. Based on the time of attending, the participants will be coded from 01, 02, ..., 40 till the sample size being completed, Blinding description: This is a single blinded study. The assessor (who going to assess the outcome measures and collect the data) will be blind. Each participant will be aware of treatment that is being used for her/him. The researcher(physiotherapist) is aware of each participant's sort of treatment. The person who prepares the article draft and Data Safety and Monitoring Committee, will not be aware of each participant's grouping. N/A Nonspecific chronic low back pain. Intervention 1: Intervention group: The intervention is Psoas muscle myofascial release technique, This technique is going to be done as following: In supine position with 90 degree hip and knees. Therapist puts her hands on Psoas muscle for 3 min and then will perform transvers sliding. In the intervention group, in addition to this technique, routine physiotherapy is performed (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy). Patients will receive 8 sessions of routine physiotherapy in 3 weeks (3 sessions per week) and 4 sessions of myofascial release therapy (in sessions 1, 3, 5, 7). Intervention 2: Control group: Participants in the control group will receive routine physiotherapy in 8 sessions (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy). Yes - There is a plan to make this available What will be shared: All data obtained, including information on the main outcomes and individual characteristics of the participants (including height, weight, body mass index and gender) will be published as an article without identifying the participant. If needed, individual information will be shared with other researchers and the Data Safety and Monitoring Committee. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions can apply for information. Conditions: Other researchers can be used to collect data or write systematic reviews, to guide and improve the quality of patients' treatment and encourage similar studies. Where to obtain: Applicants should contact the general manager of this research to obtain documentation and data. For this purpose, contact Kosar Iranpour at 00989217104152, email address K.iranpour75@gmail.com and postal code 81799-37531. Address: No. 12, Lale Ally, Farabi2 Ave, Ghadir Blvd, Sepahanshahr Town, Isfahan. How to obtain: After 6 months from the publication of the results of the study, individuals who have a certificate from academic institutions can apply for data and documents and receive the documents about 1 to 2 months later. Comments:
public Kosar Iranpour
No. 12, Lale alley, Farabi 2 Ave, Ghadir Blvd, Sepahanshahr
Isfahan Iran (Islamic Republic of) 81799-37531 +98 31 3650 2472 k.iranpour75@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Kosar Iranpour
No. 12, Lale alley, Farabi 2 Ave, Ghadir Blvd, Sepahanshahr
Isfahan Iran (Islamic Republic of) 81799-37531 0098 31 6502472 K.iranpour75@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 18_60 years old patient with diagnosed nonspecific chronic low back pain Pain in lumbar region, at least since 3 months ago Score 3_7 in Visual Analog Scale Disability index score of 4_8 in Roland‐Morris disability questionnaire Having enough literacy for filling the questionnaire Having at least two parameters of tree following conditions: - Positive modified Thomas test, at least in one side of pelvic - Tenderness due to pressure on Psoas muscle, at least in one side of pelvic - Producing pain and uncomfortable due to Psoas muscle maximum contraction, at least in one side of pelvic 18 years 60 years Both Pregnancy BMI score more than 30 History of lumbar spine surgery Low back pain due to serious spinal pathology such as tumor, infection, inflammatory disorders Symptoms of disc herniation (reduction of lower extremity force, reduction of reflexes of lower extremity, positive Straight Leg Raise test in less than 45 degrees. No pain reduction in rest, No pain increasing with activity History of fracture in spinal region History of recent trauma to spine Pain in resting Joint disorders such as Rheumatoid Arthritis Lumbar vertebral Spondylolisthesis Using paregoric and muscle relaxant medicine in past 48 hours before assessment Fibromyalgia History of myofascial or rehabilitation treatment in past 2 months M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: The intervention is Psoas muscle myofascial release technique, This technique is going to be done as following: In supine position with 90 degree hip and knees. Therapist puts her hands on Psoas muscle for 3 min and then will perform transvers sliding. In the intervention group, in addition to this technique, routine physiotherapy is performed (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy). Patients will receive 8 sessions of routine physiotherapy in 3 weeks (3 sessions per week) and 4 sessions of myofascial release therapy (in sessions 1, 3, 5, 7). Control group: Participants in the control group will receive routine physiotherapy in 8 sessions (consist of 20min electrotherapy, 5min Ultrasound, 10 min hot pack, exercise therapy). Pain score. Timepoint: Before starting the treatment, 1day and 4 weeks after the end of treatment. Method of measurement: Visual Analog Scale. Disability index. Timepoint: Before starting the treatment, 1day and 4 weeks after the end of treatment. Method of measurement: Roland‐Morris Disability Questionnaire. Esfahan University of Medical Sciences Approved 2020-09-26 Ethics committee of Isfahan University of Medical Sciences Building No. 4, Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan Isfahan Isfehan Iran (Islamic Republic of)