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IRCT20230502058059N1 IRCT 2023-07-09 University of social welfare and rehabilitation sciences Evaluation of the effect of lumbopelvic fascial release alone with lumbopelvic and cervical fascial release on pain intensity, functional disability, pressure pain threshold, quality of life and sonoelastography indices of the fascia in both regions in non-specific chronic low back pain patients associated with neck pain Evaluation of the effect of lumbopelvic fascial release alone with lumbopelvic and cervical fascial release on pain intensity, functional disability, pressure pain threshold, quality of life and sonoelastography indices of the fascia in both regions in non-specific chronic low back pain patients associated with neck pain 2023-07-15 anticipated 44 Complete https://irct.ir/trial/70255 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to two groups based on the random block method (block size of 4 and allocation ratio 1:1) using the website www.randomization.com. To conceal the sequence of random allocation, numbered sealed envelopes containing group A or group B contents will be used, Blinding description: In the present study, the outcome evaluator and the person who analyzes the results will be blind to the study conditions. In this way, the questionnaires are taken by another person and the sonoelastography is performed by a radiologist and the results are analyzed by a statistician. In this study, the patients are blinded in terms of placement in the groups, but they are not blinded in terms of the type and place of treatment they receive, because the treatment process is explained to the patient. Also, the therapist is not blind and a trained and skilled physiotherapist (myself) performs fascia release. N/A Condition 1: Low back pain. Condition 2: Neck pain. Intervention 1: The first intervention group: they receive lumbo-pelvic fascial release. Intervention 2: The second intervention group: they receive lumbo-pelvic and cervical fascial release. No - There is not a plan to make this available Justification or reason for not sharing IPD is Considering that in the ethical considerations section, we said that we do not publish the information, the data of the participants will not be published and there is no more information regarding the non-identification of individual data.
public Soodeh Zandi
No. 42, The First Bell., West Dolatshad Ave., Farid Afshar., Zafar
Tehran Iran (Islamic Republic of) 1916615463 +98 21 2200 6911 soodeh.zandi@ymail.com University of social welfare and rehabilitation sciences scientific Soodeh Zandi
No. 42, The First Bell., West Dolatshad Ave., Farid Afshar., Zafar
Tehran Iran (Islamic Republic of) 1916615463 +98 21 2200 6911 soodeh.zandi@ymail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) People with the simultaneous complication of non-specific chronic low back pain and neck pain, where the intensity of low back pain is greater compared to the neck pain Age between 20 and 55 years Not having low back pain and neck pain caused by specific pathologies Not receiving painkillers and anti-inflammatory drugs in the last 3-7 days Not currently receiving physical therapy or other treatment 20 years 55 years Both pregnancy Not attending regular therapy sessions Unwillingness to continue participating in the study Infecting or developing cases (after the start of the study) that violates the criteria for entering the study for any reason M95.9-M99. M95.9-M99. XIII Diseases of the musculoskeletal system and connective tissue XIII Diseases of the musculoskeletal system and connective tissue Rehabilitation Rehabilitation The first intervention group: they receive lumbo-pelvic fascial release. The second intervention group: they receive lumbo-pelvic and cervical fascial release. Pain score on Visual Analog Scale. Timepoint: Before the start of the intervention, at the end of the intervention and after the two-week follow-up. Method of measurement: Visual Analog Scale. Back disability score in back disability questionnaire. Timepoint: Before the start of the intervention, at the end of the intervention and after the two-week follow-up. Method of measurement: Oswestry Disability Index. Neck disability score in neck disability questionnaire. Timepoint: Before the start of the intervention, at the end of the intervention and after the two-week follow-up. Method of measurement: Neck Disability Index. Pressure pain threshold score. Timepoint: Before the start of the intervention, at the end of the intervention and after the two-week follow-up. Method of measurement: Algometer tool. Quality of life score. Timepoint: Before the start of the intervention, at the end of the intervention and after the two-week follow-up. Method of measurement: Short form health survay. Fascia elasticity. Timepoint: Before the start of the intervention, at the end of the intervention and after the two-week follow-up. Method of measurement: Sonoelastography. University of social welfare and rehabilitation sciences Approved 2023-03-15 Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences First bell, No. 42, Dolatshad West St., Farid Afshar St., Zafar St Tehran Tehran Iran (Islamic Republic of)