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IRCT20190411043240N1 IRCT 2019-05-23 The University of Kirsehir Ahi Evran Effect of the Extracorporeal Shock Wave Therapy (ESWT) in Chronic Low Back Pain Comparison of the Effect of Classical Physical Therapy Agents and Extracorporeal Shock Wave Therapy (ESWT) on Pain, Disability, Functional Status and Depression in Patients with Chronic Low Back Pain; Prospective randomized controlled trial 2019-07-20 anticipated 80 Complete https://irct.ir/trial/39510 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: simple, individual, sealed envelopes. N/A chronic low back pain. Intervention 1: Intervention group: extracorporeal shock wave therapy. The model name of the device is Modus ESWT. Device has CE ("Conformité Européene") mark. The global product (barcode) number is 8680050920224. The device is registered in Turkey Pharmaceuticals and Medical Devices National Data Bank (TİTUBB). Extracorporeal shock wave therapy (ESWT) is a noninvasive procedure using single-pulse acoustic waves produced outside the body and focused on a specific area in the body.Studies have shown that ESWT is an effective and long-term pain-reducing method for soft tissue diseases such as plantar fasciitis and achilles tendinopathy; ESWT is routinely applied in achilles tendinopathy and plantar fasciitis.Shock waves promote axonal regeneration of peripheral nerves by various molecular reactions.ESWT has been reported to induce analgesia by biochemical changes in the nerve fiber itself and to reduce inflammation of soft tissues.  It has also been shown that ESWT promotes revascularization, stimulates or re-activates the healing process of connective tissues, including tendons and bones, thereby alleviating pain and improving function.ESWT can be used to relieve pain as well as to improve muscle strength through proper motor stimulation by shock waves of muscles and tendons.ESWT device user's manual also includes low back pain in the ESWT indication list, but ESWT; There are few studies on the effects of low back pain on pain, disability and depression.ESWT will be applied in a total of 5 sessions 2-3 weeks after a minimum of 2 days. After the application of the joining gel, the shock wave probe will be placed perpendicular to the areas of the Quadratus Lumborum, Sacroiliac joint and the patient's pain, and the 20mm applicator will be applied at a pressure of 2.8 bar and at a frequency of 10 Hz with 2600 shots. Intervention 2: Intervention group: Classical Physical Therapy Agents. Classic physical therapy agents TENS 20 minutes, Hot pack 20 min, ultrasound 5 min to be applied for 15 days. Yes - There is a plan to make this available What will be shared: Comparison of the Effect of Classical Physical Therapy Agents and Extracorporeal Shock Wave Therapy (ESWT) on Pain, Disability, Functional Status and Depression in Patients with Chronic Low Back Pain; Prospective randomized controlled trial When: When the study starts, study will become available and it will ends after 1 year after the end of study To whom: For medical doctors, physiotherapists Conditions: Data/documents could be used after taking permission Where to obtain: From researcher How to obtain: People which want to access data/document can write via e-mail. Comments:
public Mehmet Okcu
Bağbaşı Mahallesi, Şht. Sahir Kurutluoğlu Cd. No: 100, 40100 Özbağ Belediyesi/Kırşehir Merkez/Kırşehir
Kirsehir Turkey 40100 +90 386 441 02 44 mehmet.okcu@ahievran.edu.tr Ahi evran university scientific Mehmet Okcu
Bağbaşı Mahallesi, Şht. Sahir Kurutluoğlu Cd. No: 100, 40100 Özbağ Belediyesi/Kırşehir Merkez/Kırşehir
Kirsehir Turkey 40100 +90 386 441 02 44 mehmet.okcu@ahievran.edu.tr Ahi evran university Turkey Male and female patients with low back pain who have been diagnosed with chronic low back pain for at least 3 months between 18- 65 years old Patients who are able to understand correctly the patient information form and cooperate Patients consenting to participate in the study according to the informed consent form 18 years 65 years Both Operational history of lumbar spine region. Vertebral compression fracture Spinal tumors Intervertebral disc infections Inflammatory rheumatic disease Pregnant patients Heart disease Structural abnormalities Whether the patient is unwilling or unable to participate for any reason Deciding whether the clinician does not benefit the patient M54.5 Low back pain Treatment - Devices Treatment - Devices Intervention group: extracorporeal shock wave therapy. The model name of the device is Modus ESWT. Device has CE ("Conformité Européene") mark. The global product (barcode) number is 8680050920224. The device is registered in Turkey Pharmaceuticals and Medical Devices National Data Bank (TİTUBB). Extracorporeal shock wave therapy (ESWT) is a noninvasive procedure using single-pulse acoustic waves produced outside the body and focused on a specific area in the body.Studies have shown that ESWT is an effective and long-term pain-reducing method for soft tissue diseases such as plantar fasciitis and achilles tendinopathy; ESWT is routinely applied in achilles tendinopathy and plantar fasciitis.Shock waves promote axonal regeneration of peripheral nerves by various molecular reactions.ESWT has been reported to induce analgesia by biochemical changes in the nerve fiber itself and to reduce inflammation of soft tissues.  It has also been shown that ESWT promotes revascularization, stimulates or re-activates the healing process of connective tissues, including tendons and bones, thereby alleviating pain and improving function.ESWT can be used to relieve pain as well as to improve muscle strength through proper motor stimulation by shock waves of muscles and tendons.ESWT device user's manual also includes low back pain in the ESWT indication list, but ESWT; There are few studies on the effects of low back pain on pain, disability and depression.ESWT will be applied in a total of 5 sessions 2-3 weeks after a minimum of 2 days. After the application of the joining gel, the shock wave probe will be placed perpendicular to the areas of the Quadratus Lumborum, Sacroiliac joint and the patient's pain, and the 20mm applicator will be applied at a pressure of 2.8 bar and at a frequency of 10 Hz with 2600 shots. Intervention group: Classical Physical Therapy Agents. Classic physical therapy agents TENS 20 minutes, Hot pack 20 min, ultrasound 5 min to be applied for 15 days. The Beck Depression Scale will be used to determine the levels of depression, and Oswestry, Health Assessment Questionnaire (Haq). Visual analogue scale (VAS) and Algometer will be used to question the pain status in individuals. Timepoint: before treatment, after treatment and at 3rd month. Method of measurement: The Beck Depression Scale will be used to determine the levels of depression, and Oswestry, Health Assessment Questionnaire (Haq). Visual analogue scale (VAS) and Algometer will be used to question the pain status in individuals. The University of Kirsehir Ahi Evran Approved 2018-11-13 Ethics committee of Kirsehir Ahi Evran University Faculty of Medicine Ahi Evran Üniversitesi Tıp Fakültesi Bağbaşı Yerleşkesi Merkez / Kirsehir/Turkey Kirsehir Kirsehir Turkey