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IRCT20210205050256N1 IRCT 2021-02-10 Riphah International University Effects of Instrument Assisted Soft Tissue Mobilization Techniques in Patients with Chronic Low Back Pain EIASTM&CPT Comparison of the Effectiveness of Instrument Assisted Soft Tissue Mobilization Techniques with and without Routine Physical Therapy in Chronic Low Back Pain Patients 2021-01-05 anticipated 38 Complete https://irct.ir/trial/54132 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Non probability convenient sampling will be used. Subjects will be randomly distributed to two groups with the use of the lottery method of randomization. Slips will be prepared from 1 to 38. They will be homogeneous in shape, color, and size etc. Furthermore, they will be shuffled and will be placed in a box. The selected 19 slips will be allocated to Group 1, who will receive instrument assisted soft tissue mobilization with routine physical therapy and the other 19 will be allocated to Group 2, who will receive routine physical therapy, Blinding description: Outcome assessor blinding: Every patient will be assessed by independent assessor at the start and end of total treatment sessions to keep the assessment unbiased. N/A Low Back Pain. Intervention 1: Intervention group 1: Instrument assisted soft tissue mobilization with routine physical therapy. In this group, patients will receive instrument assisted soft tissue mobilization during 4 weeks: sacrum, hip lateral rotators, and hamstring bilaterally and general exercise. In the first, subjects will be asked to kneel directly on the bed. The hip lateral rotators instrument assisted soft tissue mobilization will be applied to kneeling prone position with knee and hip flexion side lying position at gluteus maximus and gluteus medius. The hamstring bilaterally instrument assisted soft tissue mobilization will be applied to prone position at biceps femoris, semitendinosus, and semimembranosus. This treatment will be applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle. Following immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for additional 20-seconds, resulting in a total treatment time of approximately 40 seconds. However, this group will also be given conventional treatment which will be hot pack and lumbar isometrics to maintain the blood circulation and muscle strength. Intervention 2: Intervention group 2: Routine Physical Therapy. In this group, the patients will receive general exercise. It will include stretching exercises and stationary bicycling for 10–15 minutes. Three sets of fifteen repetitions will be performed, with rest times of 1 minute between sets during 4 weeks. These patients will also receive conventional treatment which will be hot pack and lumbar isometrics to maintain the blood circulation and muscle strength. 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 further information
public Dr. Naveed Anwar
Quaid e Azam Campus, 28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpath, Lahore.
Lahore Pakistan 54000 +92 42 35126110 naveed.anwer@riphah.edu.pk Riphah International University scientific Dr. Naveed Anwar
Quaid e Azam Campus, 28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpath, Lahore.
Lahore Pakistan 54000 +92 42 35126110 naveed.anwer@riphah.edu.pk Riphah International University Pakistan Age between 40 and 60 years Not make use of continuous drugs for low back pain Previous spine surgeries Do not present medical restriction to practice physical exercise or if they presented any limitations in lower limbs that physical exercises 40 years 60 years Both Participants will be excluded if they had neurological signs, specific spinal pathology (e.g. malignancy, or inflammatory joint or bone disease) Patients who will be reported osteoarthritis or disc lesions (prolapse, protrusion or herniation without neurological compromise) with or without leg pain Pregnant women M54.5 Chronic Low Back Pain Treatment - Devices Treatment - Other Intervention group 1: Instrument assisted soft tissue mobilization with routine physical therapy. In this group, patients will receive instrument assisted soft tissue mobilization during 4 weeks: sacrum, hip lateral rotators, and hamstring bilaterally and general exercise. In the first, subjects will be asked to kneel directly on the bed. The hip lateral rotators instrument assisted soft tissue mobilization will be applied to kneeling prone position with knee and hip flexion side lying position at gluteus maximus and gluteus medius. The hamstring bilaterally instrument assisted soft tissue mobilization will be applied to prone position at biceps femoris, semitendinosus, and semimembranosus. This treatment will be applied for approximately 20-seconds in a direction parallel to the muscle fibers being treated with the instrument at a 45° angle. Following immediately by treating the muscles in a direction perpendicular to the muscle fibers with the instrument at a 45° angle for additional 20-seconds, resulting in a total treatment time of approximately 40 seconds. However, this group will also be given conventional treatment which will be hot pack and lumbar isometrics to maintain the blood circulation and muscle strength. Intervention group 2: Routine Physical Therapy. In this group, the patients will receive general exercise. It will include stretching exercises and stationary bicycling for 10–15 minutes. Three sets of fifteen repetitions will be performed, with rest times of 1 minute between sets during 4 weeks. These patients will also receive conventional treatment which will be hot pack and lumbar isometrics to maintain the blood circulation and muscle strength. Pain. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Numeric Pain Rating Scale (NPRS). Function. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Modified Oswestry Disability Index (MODI) and Rolland Morris Questionnaire (RMQ). Riphah International University Approved 2020-03-27 Riphah Ethical Committee Quaid e Azam Campus, 28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpath, Lahore. Lahore Punjab Pakistan