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IRCT20250205064650N1 IRCT 2025-03-13 Shahid Beheshti University of Medical Sciences The effect of manipulation derived from traditional medicine on low back pain Evaluation of an Iranian Traditional Medicine Based Manipulation (Hasanzadeh Technique) on Clinical Symptoms and Quality of Life of Patients Chronic Radicular Low Back Pain compared to Physiotherapy. 2025-02-19 anticipated 70 Complete https://irct.ir/trial/81779 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to assign patients to two treatment groups, the Blocked Randomization method with blocks of four will be used. First, six possible states of blocks (BAAB, ABBA, BABA, BBAA, ABAB, AABB) are listed and a number from one to six is assigned to each block. Then, numbers between one and six are randomly selected using a table of random numbers, and then people are assigned to the Manipulation (A) and Physiotherapy (B) group based on the block corresponding to the selected number, and this work is done until completion. The sample size will continue. N/A Radicular Low Back Pain. Intervention 1: Intervention group: Administering a technique from Traditional Medicine known as "Ghamz therapy", which involves applying pressure with a specially designed wooden tool to targeted areas of the patient's back and lower limbs. This treatment consists of three sessions: one at the beginning of the visit, another one week later, and a final session 37 days after the intervention begins. Intervention 2: Control group: Patients in the physiotherapy group will receive 10 consecutive one-hour physiotherapy sessions three times a week. Each session will include hot pack therapy (heat at 71-74°C for 20 minutes), transcutaneous electrical nerve stimulation (TENS; at a frequency of 100 Hz for a total of 20 minutes, intensity adjusted according to patient tolerance), and ultrasound (1 MHz, 1.5 W/cm2 for a total of 10 minutes) applied to the lumbar region. Yes - There is a plan to make this available What will be shared: Information on the main outcomes of the study When: 6 months after the publication of the research paper To whom: Faculty members of universities Conditions: With the aim of modeling to conduct a similar study Save translation Where to obtain: Email of the chief researcher to the following address: Rokhafruz.bahman@gmail.com How to obtain: Submission of the request via email, obtaining approval from the center's research council, and then receiving the requested information. Comments:
public Bahman Rokhafrooz
Department of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Shams Alley, Vali Asr ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rokhafruz.bahman@gmail.com Shahid Beheshti University of Medical Sciences scientific Bahman Rokhafrooz
Department of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Shams Alley, Vali Asr ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 rokhafruz.bahman@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) unilaterally radicular low back pain Completed informed consent to enter the study Pain onset at least 8 weeks ago (continuous or intermittent) Age between 18-60 years Pain severity VAS score ≥ 3 18 years 60 years Both Previous surgical history or RCLBP Presence of paresthesia and specific pathology including spondylolysis, spondylolisthesis, vertebral fracture Having muscle wasting and weakness of the lower limbs• Having various myopathies Fever, sweating and unexplained weight loss in the last few months Long-term corticosteroid therapy Symptoms of cauda equina syndrome including numbness and weakness of both legs, pain radiating to the anus, perineal numbness, sphincter paralysis Having malignancy Having an indication for emergency surgery with criteria including acute onset of motor deficit, perineal numbness, and bladder and bowel dysfunction in cauda equina syndrome Severe osteoporosis according to history if there is a bone density scan T-score less than -2.5 Vascular problems of the lower extremities Diabetes: Given that in this study, neuromuscular examination is not performed and there is no estimate of nerve involvement, diabetic patients were excluded from this study History of hip fracture and dislocation Known psychological disorders based on the patient's history including major depression, severe anxiety, psychosis, schizophrenia, bipolar disorder, and personality disorder History of surgery and muscle and fascial tears in the lower extremities Patients treated with blood thinners including warfarin and heparin History of use of injectable opioids History of rheumatic diseases M54.5 Low back pain Treatment - Other Treatment - Surgery Intervention group: Administering a technique from Traditional Medicine known as "Ghamz therapy", which involves applying pressure with a specially designed wooden tool to targeted areas of the patient's back and lower limbs. This treatment consists of three sessions: one at the beginning of the visit, another one week later, and a final session 37 days after the intervention begins Control group: Patients in the physiotherapy group will receive 10 consecutive one-hour physiotherapy sessions three times a week. Each session will include hot pack therapy (heat at 71-74°C for 20 minutes), transcutaneous electrical nerve stimulation (TENS; at a frequency of 100 Hz for a total of 20 minutes, intensity adjusted according to patient tolerance), and ultrasound (1 MHz, 1.5 W/cm2 for a total of 10 minutes) applied to the lumbar region. Pain intensity. Timepoint: Before the start of the intervention and 38 days after the start of the intervention. Method of measurement: Visual Analogue Scale (VAS). Quality of life. Timepoint: Before the start of the study and 38 days after the start of the study. Method of measurement: WHO quality of life questioner (Short Form-WHOQOL). Diability. Timepoint: Before the start of the study and 38 days after the start of the study. Method of measurement: Roland-Morris disability questionnaire. Shahid Beheshti University of Medical Sciences Approved 2025-01-12 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Valenjak. Tehran Tehran Iran (Islamic Republic of)