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IRCT20180604039980N1 IRCT 2021-03-13 Shiraz University of Medical Sciences Repetitive transcranial magnetic stimulation and cervical spondylotic myelopathy Evaluation of the effect of repetitive transcranial magnetic stimulation in cervical spondylotic myelopathy patients after surgery 2021-04-09 anticipated 52 Complete https://irct.ir/trial/53833 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, two groups are defined, in the first stage, both groups receive the same intervention, and then in the second stage, only one group receives the second intervention, Randomization description: We will perform a prospective single-blind, randomized trial in which 52 cervical myelopathy spondylosis(CSM)patients after surgery will be enrolled. A general practitioner not only will assess 52 patients for eligibility, but also will evaluate baseline characteristics of eligible patients before randomization. Written informed consent will be obtained from all patients before operation. Eligible participants will be randomly assigned to two groups by opening sealed envelopes. The envelopes will be prepared beforehand and sorted randomly by using random allocation software (computerized random number generators). Randomization will be performed by a neurosurgery resident after the inclusion of the patients into the study by the surgeon. The patient will draw one of the two envelopes indicating the combination of repetitive transcranial magnetic stimulation (rTMS) and physiotherapy or only physiotherapy. The patients will be randomly allocated to one of two groups. 26 patients will be rehabilitated by the combination of rTMS and physiotherapy (group 1) and 26 patients will be rehabilitated by physiotherapy alone (group 2), Blinding description: The data analysts and evaluators will be blind in this study, therefore it will be a single-blind study. N/A Effects of the combination of repetitive transcranial magnetic stimulation (rTMS) and physiotherapy as well as physiotherapy alone on motor and sensory improvement were assessed after spinal cord decompression in patients with CSM.. Intervention 1: Control group: Intervention group: Performing physiotherapy on patients after cervical myelopathy spondylosis. Conventional physiotherapy for 2 weeks (each week, 5 sessions, and each session, 30 min). The conventional physiotherapy in this study consisted of, massage and strengthening,. Intervention 2: Intervention group: Performing repetitive transcranial magnetic stimulation (rTMS) and physiotherapy on patients after cervical myelopathy spondylosis. Non-invasive magnetic stimulation of the patient’s motor cortex will be performed postoperatively (1800 pulses in 90 trials with a frequency of 10 Hz, 90% motor threshold (MT)) for 2 weeks (each week, 5 sessions and each session, 20 min) and conventional physiotherapy 30 min after each session.The conventional physiotherapy in this study consisted of, massage and strengthening,. Yes - There is a plan to make this available What will be shared: physiotherapy with/without rTMS was performed after surgical decompression in CSM patients and the effects of physiotherapy whit/without rTMS on the motor and sensory improvement were evaluated using neurologic assessment elements (ASIA score, mJOA scale, Ashworth scale, and Nurick grade). When: After the publication of the results. To whom: All readers Conditions: All data of the patients will be available to the corresponding author of this proposal. For any query on the data of the patients in this study, you can contact Shiraz Neuroscience Research Center and pose your request to the corresponding author of this study. Where to obtain: Shiraz Neuroscience Research Center How to obtain: Contact Shiraz Neuroscience Research Center Comments:
public Dr. Majid Reza Farrokhi
Shiraz Neurosciences Research Center-Chamran Hospital-Shiraz
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3623 4508 farrokhimr@yahoo.com Shiraz University of Medical Sciences scientific Dr. Majid Reza Farrokhi
Shiraz Neurosciences Research Center-Chamran Hospital-Shiraz
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3623 4508 farrokhimr@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) • All the patients with a diagnosis of cervical spondylotic myelopathy and neurological deficits in the neurological exam. The patients whose information and follow-ups were complete. The patients with an age range between 18 & 70 years old. • The patients with have symptoms between 2 months to 4 years before operation / Operation to rTMS interval below 6 months. • The patients which in pre operation cervical spine MRI having one or more levels of stenosis or cord compression. 18 years 70 years Both The patients with cognitive disorder, neurological or musculoskeletal disorder The patients with any contraindication for receiving magnetic stimulation like vascular clipping in the brain, intraocular prosthesis and etc. M47.12 Other spondylosis with myelopathy, cervical region Rehabilitation Rehabilitation Control group: Intervention group: Performing physiotherapy on patients after cervical myelopathy spondylosis. Conventional physiotherapy for 2 weeks (each week, 5 sessions, and each session, 30 min). The conventional physiotherapy in this study consisted of, massage and strengthening, Intervention group: Performing repetitive transcranial magnetic stimulation (rTMS) and physiotherapy on patients after cervical myelopathy spondylosis. Non-invasive magnetic stimulation of the patient’s motor cortex will be performed postoperatively (1800 pulses in 90 trials with a frequency of 10 Hz, 90% motor threshold (MT)) for 2 weeks (each week, 5 sessions and each session, 20 min) and conventional physiotherapy 30 min after each session.The conventional physiotherapy in this study consisted of, massage and strengthening, Motor and sensory changes. Timepoint: Before and after the intervention. Method of measurement: Motor and sensory changes (ASIA score). Ability to walking. Timepoint: Before and after the intervention. Method of measurement: Ability to walking (Nurick scale). Muscle tone. Timepoint: Before and after the intervention. Method of measurement: Muscle tone (modified Ashworth scale). Motor and sensory dysfunction. Timepoint: Before and after the intervention. Method of measurement: Motor and sensory dysfunction:(Modified Japanese Orthopaedic Association scoring system). ASIA score(Motor and sensory changes). Timepoint: Before and after the intervention. Method of measurement: Motor index scoring: It is done by rating zero to 5 muscle strength and giving a score of zero to 5 to each key muscle. Due to the presence of 5 key muscles in each limb, the maximum score of each limb is 25 points (5 × 5) and in a total of four limbs, the maximum score is 100 points. Sensory index scoring: There is a maximum total of 56 points each for light touch and pinprick (sharp/dull discrimination) modalities, for a total of 112 points per side of the body. Nurick scale(Ability to walking). Timepoint: Before and after the intervention. Method of measurement: Signs or symptoms of root involvement but without evidence of spinal cord disease→ grade=0 Signs of spinal cord disease but no difficulty in walking → grade=1 Slight difficulty in walking which did not prevent full-time employment→ grade=2 Difficulty in walking which prevented full-time employment or the ability todo all housework, but which was not so severe as to require someone else’s help to walk → grade=3 Able to walk only with someone else’s help or with the aid of a frame → grade=4 Chair bound or bedridden → grade=5. Modified Ashworth scale(Muscle tone). Timepoint: Before and after the intervention. Method of measurement: 0: No increase in muscle tone 1: Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion, when an affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion 2: A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved 3: Considerable increase in muscle tone, passive movement difficult 4: Affected part(s) rigid in flexion or extension. Modified Japanese Orthopaedic Association scoring system(Motor and sensory dysfunction). Timepoint: Before and after the intervention. Method of measurement: It is an 18-point scale that addresses upper (0-5 points) and lower extremity (0-7 points) motor function, sensation (0-3 points), and sphincter dysfunction (0-3 points). A score of 18 reflects no neurological deficits whereas a lower score indicates a greater degree of disability and functional impairment. Shiraz University of Medical Sciences Approved 2017-07-10 Ethics committee of Shiraz University of Medical Sciences Central building of Shiraz University of Medical Sciences Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)