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IRCT20220506054756N1 IRCT 2022-06-17 Mazandaran University of Medical Sciences The Effectiveness of Acupuncture and Laser in Low Back Pain Comparison of Acupuncture and High Intensity Laser Therapy on Pain, Quality of Life and Disability of Patients with Disc Herniation in Patients with Chronic Low Back Pain, a Randomized Control Study 2022-06-22 anticipated 60 Complete https://irct.ir/trial/63620 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients after selecting and obtaining informed consent to participate in the study after explaining the steps of the study, by simple random allocation using a table of random numbers by computer and online) using the site (www.random.org/ integres as Randomly divided into three groups A, B and C. Patients were divided into three groups, each with its own code, which were written on the sheets in which the patient group was identified. The codes placed patients in one of three groups by selecting each envelope. N/A Lumbar disc herniation, chronic low back pain, sciatica. Intervention 1: Intervention group: In the high-power laser intervention group, high-power laser treatment patients will receive high-power laser from the device manufactured by Novin Company. The device provides the following options: high-power laser with pulse emission (808 nm), very high peak power (1500 mW), frequency 100 Hz, energy density 1200 mJ / cm2 energy density), pulse duration 8:30 minutes, Work cycle about 0.1%, probe diameter 0.5 cm and spot size 0.2 cm2. While the patient is lying down, the handpiece will be treated in contact and perpendicular to the area. The laser will be applied transversely and longitudinally to the back of the waist in the paraspinal region, lower back, quadriceps and buttocks. Also includes hotspots and trigger points. This procedure is repeated three times a week (10 sessions in total). Intervention 2: Intervention group: Proximal and distal lumbar points are selected in the acupuncture treatment group. After disinfecting the skin with alcohol, the needle with a length of 25 and a diameter of 0.30 mm will be placed in the points ST36 GB30, GB34, BL25, BL23. In addition to the acupuncture mentioned, acupuncture is performed on the trigger points of the waist in each session. All needles are manipulated at 45 degrees clockwise and counterclockwise and held for 15 minutes. This procedure is repeated three times a week (10 sessions in total). Intervention 3: Control group: Control group: The group was treated with medication and exercise. The method of exercising was designed to be easily done at home. The exercises will be performed with the aim of increasing flexibility, endurance, strength, stability and painless mobility, as well as controlling the posture of the lumbar spine. General exercises and central stabilization are performed on the muscles responsible for central stabilization, and according to the patient's tolerance, gentle stretching of the lumbar, hip and thigh muscles is performed in the same way for all patients. All treatment groups will be given the same instructions to exercise three times a day for 4 weeks. Medication also includes 2 capsules of piroxicam once a day (a total of 20 mg and methocarbamol 500 mg tablets three times a day for 2 weeks. During this time, follow-up exercise and medication will be done by phone). became. Yes - There is a plan to make this available What will be shared: All potential personal data is shared after individuals are not identified. When: Access starts 6 months after the results are published To whom: For researchers working in academic and scientific institutions Conditions: For researchers working in academic and scientific institutes, in order to conduct further studies in the future, the study method and study statistical data are available. Where to obtain: Mahin Jafari Kakroodi 1368@yahoo.com; Dr. Mahin Safari 00981133366552 How to obtain: After receiving the documentation request email, the data file will be sent. Comments:
public Mahin Safari
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3336 6552 Mahinsafarikakroodi1368 @yahoo.com Mazandaran University of Medical Sciences scientific Mahin Safari
Sports Medicine Department, Mostafavian Clinic, Razi St., Sari
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3336 6552 Mahinsafarikakroodi1368 @yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 60 years They signed informed consent forms and volunteered to participate in the experiments They have had back pain for more than 3 months On examination they have local sensitivity in the back, buttocks and legs, and shooting pain, and they have a Straight Leg Rising (SLR) test or a Slump test MRI of the lumbar disc herniation was seen Have the mental ability to answer questionnaire questions 18 years 60 years Both Acute trauma or fracture of the lumbar spine or dysplasia of the spinal structure (spondylolysis) Congenital anomaly, abdominal aneurysm 3. Lumbar spine surgery Uncontrolled or severe metabolic disorders or cardiovascular, hepatic and renal disorders Lumbar spine surgery Uncontrolled or severe metabolic disorders or cardiovascular, hepatic and renal disorders Inflammatory pain Severe or progressive neurological disorders or lumbar instability Physiotherapy treatments on the back in the last 3 months History of lumbar injection in the last 4 weeks Severe osteopenia Systemic rheumatic disease (rheumatoid arthritis and fibromyalgia) Spinal cancers and patients with spinal tuberculosis Danger symptoms include nocturnal pain, recent involuntary weight loss, and symptoms of Cauda equina syndrome Spondylolisthesis Hypersensitivity to piroxicam and methocarbamol Patients who have undergone lumbar spine fusion or have indication for surgery Pregnant patients Patients who have had a tattoo or melanocytic moles in or near the treatment areas Patients with lupus or any other autoimmune disease, thrombophlebitis or anemia, and skin allergies Not participating in treatment sessions for more than 2 sessions Dissatisfaction with participating in the study at any stage of the study No referral for follow-up 4 weeks later and no phone response 3 months after starting treatment Emergence of severe medical diseases during the study that affect the individual's referral and follow-up M54.40 Lumbago with sciatica, unspecified side Rehabilitation Rehabilitation Rehabilitation Intervention group: In the high-power laser intervention group, high-power laser treatment patients will receive high-power laser from the device manufactured by Novin Company. The device provides the following options: high-power laser with pulse emission (808 nm), very high peak power (1500 mW), frequency 100 Hz, energy density 1200 mJ / cm2 energy density), pulse duration 8:30 minutes, Work cycle about 0.1%, probe diameter 0.5 cm and spot size 0.2 cm2. While the patient is lying down, the handpiece will be treated in contact and perpendicular to the area. The laser will be applied transversely and longitudinally to the back of the waist in the paraspinal region, lower back, quadriceps and buttocks. Also includes hotspots and trigger points. This procedure is repeated three times a week (10 sessions in total) Intervention group: Proximal and distal lumbar points are selected in the acupuncture treatment group. After disinfecting the skin with alcohol, the needle with a length of 25 and a diameter of 0.30 mm will be placed in the points ST36 GB30, GB34, BL25, BL23. In addition to the acupuncture mentioned, acupuncture is performed on the trigger points of the waist in each session. All needles are manipulated at 45 degrees clockwise and counterclockwise and held for 15 minutes. This procedure is repeated three times a week (10 sessions in total). Control group: Control group: The group was treated with medication and exercise. The method of exercising was designed to be easily done at home. The exercises will be performed with the aim of increasing flexibility, endurance, strength, stability and painless mobility, as well as controlling the posture of the lumbar spine. General exercises and central stabilization are performed on the muscles responsible for central stabilization, and according to the patient's tolerance, gentle stretching of the lumbar, hip and thigh muscles is performed in the same way for all patients. All treatment groups will be given the same instructions to exercise three times a day for 4 weeks. Medication also includes 2 capsules of piroxicam once a day (a total of 20 mg and methocarbamol 500 mg tablets three times a day for 2 weeks. During this time, follow-up exercise and medication will be done by phone). became. Pain intensity, quality of life, degree of disability in patients with chronic low back pain. Timepoint: Initially studied, 4 weeks and three months after starting treatment. Method of measurement: McGill Pain Questionnaire ,Oswestry Low Back Pain Disability Questionnaire, WHO Quality of Life, Visual Analogue Scale. Mazandaran University of Medical Sciences Approved 2022-06-01 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, beginning of Vali Asr Highway, Joybar Three Ways,Imam Square, Sari, Mazandaran, Iran Sari Mazandaran Iran (Islamic Republic of)