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IRCT20181225042118N1 IRCT 2019-09-21 Tehran University of Medical Sciences Effect of Fateh Massage on Low Back Pain Comparing the Effect of an Iranian Massage (Fateh Method) on Pain and Disability of Patients Suffering from Chronic Low Back Pain with Physiotherapy and Acupuncture 2019-09-19 anticipated 90 Complete https://irct.ir/trial/41740 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A chronic low back pain. Intervention 1: Intervention group 1: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. In this group 10 sessions of massage with the special method of Fateh -deep fascial release- is done. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. Intervention 2: Intervention group 2: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Acupuncture patients receive 10 sessions of therapy each 20 minutes, twice a week. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. Intervention 3: Control group: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Patients of physiotherapy group receive 10 sessions of standard physiotherapy for chronic low back pain. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. 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 there is no more information
public Parva Namiranian
No 6, Entesariyeh st., 2nd alley, north karegar street
Tehran Iran (Islamic Republic of) 1413915518 +98 21 8800 3198 p-namiranian@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammad Hossein Ayati
North sarparast, Ahmadieh health building
Tehran Iran (Islamic Republic of) 1417653761 +98 21 8897 6527 mh-ayati@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic low back pain without paresthesis and radicular pain and any specific pathology Pain more than 3 months Confirmation of low back pain and clinical examination by expert to exclude pathologies 19 years 69 years Both Pregnancy or breastfeeding History of surgery due to low back pain Red flags that need more investigations or surgery Ankylosing Spondylitis Neuropathy or neurologic problems in physical examination Severe untreated Scoliosis Infection in low back or spinal cord Acute radiculopathy Menthal problems Acute trauma Rheumatoid inflammatory disorders Uncontrolled Hypertension or Diabetus Mellitus Digestive system problems including stomach pain or ulcer, IBD Low back pain due to Uterus conditions Signs of weakness or Emtela Use of Digoxin, Warfarin; Heparin Addiction to alcohol or drugs and so on History of epidural or transforaminal injection of anesthetics or corticosteroids during 4 weeks prior to start of treatment M54.5 Loin pain, Low back strain, Lumbago NOS Rehabilitation Rehabilitation Rehabilitation Intervention group 1: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. In this group 10 sessions of massage with the special method of Fateh -deep fascial release- is done. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. Intervention group 2: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Acupuncture patients receive 10 sessions of therapy each 20 minutes, twice a week. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. Control group: patients are selected according to inclusion criteria and examined by a doctor. After elimination of patients with exclusion criteria, the research is explained to patients and the ones who accept to be part of the study, fill the written consent form out. Patients of physiotherapy group receive 10 sessions of standard physiotherapy for chronic low back pain. lifestyle and exercise are taught to the patients to relieve pain and exercise instructions are given to each. Diclofenac is also given to patients to use if needed (one 100 mg Tablet of Iran Najou pharmacy company) and write down the exact number of tablets carefully. Pain level due to low back pain. Timepoint: Before starting study, after the intervention, one month after intervention. Method of measurement: Visual Analogue Scale questionnaire. Disability level due to low back pain. Timepoint: Before starting study, after the intervention, one month after intervention. Method of measurement: Roland Morris disability questionnaire. Tehran University of Medical Sciences Approved 2018-12-15 Ethics committee of Tehran University of Medical Sciences Central building of Tehran University of Medical Sciences, Ghods street crossing Keshavarz Bld Tehran Tehran Iran (Islamic Republic of)