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IRCT20180108038268N3 IRCT 2018-04-13 Ahi Evran University Faculty of Medicine Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study 2015-02-01 anticipated 100 Complete https://irct.ir/trial/30190 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Casual randomization using sealed numbered envelopes without strata or blocks was performed by an administrative assistant. The same physician blinded to randomization evaluated all the patients before treatment, and on the first and twelfth week after the end of the treatments. After evaluation by the physiatrist the patients were randomized into three groups: Group 1: The patients in this group were applied interferential current with vacuum electrodes (n = 34) and exercise therapy. Group 2: The patients in this group were applied interferential current with carbon-silicone pad electrodes (5x5 cm) and exercise therapy. Group 3 (control group): The patients in this group have performed only exercise therapy, Blinding description: Casual randomization using sealed numbered envelopes without strata or blocks was performed by an administrative assistant. The same physician blinded to randomization evaluated all the patients before treatment, and on the first and twelfth week after the end of the treatments. Patients were not blinded. N/A Low back pain (Pain between 12th rib and gluteal fold)- nonspesific origin. Intervention 1: Intervention group 1: The patients in this group were applied interferential current with vacuum electrodes (n = 34). Four vacuum electrodes were placed so that the painful area remained in the middle. The sponges were wetted with tap water and placed in the electrode cups. To apply the electrodes to the patient, the cups were slightly squeezed, brought into contact with the skin and held there for a few minutes until suction occurred. Before application of IFT, hot pack was applied for 20 minutes to the low back. The patients in this group also received exercise therapy. Intervention 2: Intervention group 2: The patients in this group were applied interferential current with carbon-silicone pad electrodes (5x5 cm) (n = 34). Treatment of subjects with bilateral LBP involved paraspinal application of the cathode and anode electrodes at the lateral limits of the painful area parallel to the vertebral column. The sponges for the pad electrodes were wetted with tap water and placed them to the area to be treated using straps in the electrode cups. Before application of IFT, hot pack was applied for 20 minutes to the low back. The patients in this group also received exercise therapy. Intervention 3: Control group: The patients in this group have performed only exercise therapy and hot pack was applied for 20 minutes to the low back (n = 32). Patients were requested to do core strengthening and spine stabilization exercises. The stabilization training included: activation techniques for the neutral spine position, training the activation transversus abdominis, external and internal obliques, training the activation diaphragmatic breathing, myofascial release techniques for the erector spinae muscle, exercising the coordination of superficial and deep trunk muscles, and postural and dynamic training. The exercises were performed 5 times a week. The duration of a training session was 45 min (each exercise once a day with 20 repetitions). Yes - There is a plan to make this available What will be shared: Does The Application of Interferential Current Therapy with Vacuum Electrodes Provide Additional Effect in Patients with Nonspecific Chronic Low Back Pain? A Randomized Controlled Study This is a scientific study which was being conducted to evaluate effectiveness of interferential current therapy on pain, disability and quality of life in patients with chronic low back pain and to compare the advantages of application IFT with vacuum and carbon silicon pad electrodes to each other. When: The data will become available after publishing process. To whom: To the patints, to the PMR specialists, to the physioteharpist Conditions: Data is available after getting permission from the authors. Where to obtain: Via e-mail. How to obtain: For a request, one can write an e-mail to the address : faybalarem@gmail.com Comments:
public Fatmanur Aybala Koçak
Bağbaşı Mah. Şehit Sahir Kurutluoğlu Cad. No: 100
Kırşehir Turkey 40100 +90 386 213 45 15 aybala.kocak@ahievran.edu.tr Ahi Evran University Faculty of Medicine scientific Fatmanur Aybala Koçak
Bağbaşı Mah. Şehit Sahir Kurutluoğlu Cad. No: 100
Kırşehir Turkey 40100 +90 386 213 45 15 aybala.kocak@ahievran.edu.tr Ahi Evran University Faculty of Medicine Turkey To be more than 18 years old Seeking treatment for chronic low back pain 18 years 65 years Both cognitive dysfunction neurological deficits an extruded and/or sequestrated lumbar disc herniation spinal fusion pregnancy malignancy spinal compression fracture spondylolisthesis severe peripheral neuropathy an aortic aneurysm vertebral infection rheumatological disease vertebral column surgery M54.5 Low back pain Treatment - Devices Treatment - Devices Treatment - Other Intervention group 1: The patients in this group were applied interferential current with vacuum electrodes (n = 34). Four vacuum electrodes were placed so that the painful area remained in the middle. The sponges were wetted with tap water and placed in the electrode cups. To apply the electrodes to the patient, the cups were slightly squeezed, brought into contact with the skin and held there for a few minutes until suction occurred. Before application of IFT, hot pack was applied for 20 minutes to the low back. The patients in this group also received exercise therapy Intervention group 2: The patients in this group were applied interferential current with carbon-silicone pad electrodes (5x5 cm) (n = 34). Treatment of subjects with bilateral LBP involved paraspinal application of the cathode and anode electrodes at the lateral limits of the painful area parallel to the vertebral column. The sponges for the pad electrodes were wetted with tap water and placed them to the area to be treated using straps in the electrode cups. Before application of IFT, hot pack was applied for 20 minutes to the low back. The patients in this group also received exercise therapy. Control group: The patients in this group have performed only exercise therapy and hot pack was applied for 20 minutes to the low back (n = 32). Patients were requested to do core strengthening and spine stabilization exercises. The stabilization training included: activation techniques for the neutral spine position, training the activation transversus abdominis, external and internal obliques, training the activation diaphragmatic breathing, myofascial release techniques for the erector spinae muscle, exercising the coordination of superficial and deep trunk muscles, and postural and dynamic training. The exercises were performed 5 times a week. The duration of a training session was 45 min (each exercise once a day with 20 repetitions). Pain intensity. Timepoint: pretreatment, one week and twelve weeks after the treatment. Method of measurement: The VAS pain assessment scale was used for subjective assessment of the pain. Disability. Timepoint: pretreatment, one week and twelve weeks after the treatment. Method of measurement: The Oswestry questionnaire (The Oswestry Low Back Pain Disability Questionnaire, Oswestry Disability Index ) was used to evaluate the functional ability of patients. Quality of life. Timepoint: pretreatment and twelve weeks after the treatment. Method of measurement: Short Form 36 (SF-36) was used to assess quality of life of the patients. Ahi Evran University Faculty of Medicine Approved 2015-01-12 Turgut Özal Üniversitesi Tıp Fakültesi Etik Kurulu Alparslan Türkeş Cad. Cad. No:57 Emek Ankara Merkez Turkey