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IRCT20100127003217N15 IRCT 2023-11-01 Tabriz University of Medical Sciences Comparative study of radial shockwave therapy and high intensity laser therapy in the treatment of patients with myofascial pain syndrome in neck and upper back area Comparative study of radial shockwave therapy and high intensity laser therapy in the treatment of patients with myofascial pain syndrome in neck and upper back area 2023-10-23 anticipated 40 Complete https://irct.ir/trial/73364 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Persons in a simple random way with random block method using 2 blocks and software random array subset selection (RASS) divided to two groups of shock wave and high power laser with a 1:1 allocation ratio using opaque sealed envelopes containing the numbers 1 and 2 in order to hide the process, Blinding description: The process of shock wave therapy and high-power laser is performed by a physiatrist and the assessment of patients before and after treatment is done by a resident of physical medicine and rehabilitation, who is unaware of the type of group. N/A Myofascial pain syndrome. Intervention 1: Intervention group: The first group, radial shock wave therapy (ESWT: Extracorporeal shock wave therapy) in 3 sessions, 2 sessions per week with an intensity of 0.2 mj/mm2, frequency of 10 Hz, number of 1000 impulses along with acetaminophen 500 mg and methocarbamol 500 mg every 12 hours for 10 days, upper trapezius stretching, isometric cervical paravertebral, posterior shoulder capsule stretching, and shrug exercises will be taught in three to ten sets during the treatment period of up to 6 weeks to be performed at home. Intervention 2: Intervention group: The second group, high intensity laser therapy (HILT) in 5 sessions, 3 sessions per week, with a total energy output of 1060 joules divided into three phases of 500, 60 and 500 joules, intensity 50 J/cm2 and average power: 3W along with acetaminophen 500 mg and methocarbamol 500 mg every 12 hours for 10 days and upper trapezius stretching exercises, isometric cervical paravertebral stretching, posterior shoulder capsule stretching and shrug exercise in three to ten sets during the treatment period They will be trained for up to 6 weeks to do at home. 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 No more information
public Hiva Shadmani
Physical Medicine & Rehabilitation Ward, Imam Reza Hospital, Golgasht Ave
Tabriz Iran (Islamic Republic of) 5698745213 +98 41 3336 1928 H.shadmany@gmail.com Tabriz University of Medical Sciences scientific Fariba Eslamian
Golgasht Ave.,Imam Reza Hospital,Department of Physical Medicine and rehabilitation
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3337 3967 eslamiyanf@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Acute or chronic pain in the neck and shoulder muscles The presence of trigger points and tight bands in the muscles around the neck and head more than 2 points The appearance of referred pain in the peripheral muscle in response to pressure on the trigger point 20 years 60 years Both The presence of clear radiculopathy based on the history and the presence of one of the findings of radiculopathy in the form of weakness, radicular pain, or decreased reflexes, or upper limb sensation disorder, and a positive Spurling test The presence of extrude cervical discopathy proven in MRI The presence of severe cervical degenerative changes and the presence of radiculopathy History of cervical spine surgery or trauma Existence of systemic diseases such as bleeding disorders or rheumatological and cardiovascular diseases History of taking psychological drugs Pregnancy Malignancy R52.2 Other chronic pain Treatment - Devices Treatment - Devices Intervention group: The first group, radial shock wave therapy (ESWT: Extracorporeal shock wave therapy) in 3 sessions, 2 sessions per week with an intensity of 0.2 mj/mm2, frequency of 10 Hz, number of 1000 impulses along with acetaminophen 500 mg and methocarbamol 500 mg every 12 hours for 10 days, upper trapezius stretching, isometric cervical paravertebral, posterior shoulder capsule stretching, and shrug exercises will be taught in three to ten sets during the treatment period of up to 6 weeks to be performed at home. Intervention group: The second group, high intensity laser therapy (HILT) in 5 sessions, 3 sessions per week, with a total energy output of 1060 joules divided into three phases of 500, 60 and 500 joules, intensity 50 J/cm2 and average power: 3W along with acetaminophen 500 mg and methocarbamol 500 mg every 12 hours for 10 days and upper trapezius stretching exercises, isometric cervical paravertebral stretching, posterior shoulder capsule stretching and shrug exercise in three to ten sets during the treatment period They will be trained for up to 6 weeks to do at home Pain intensity. Timepoint: Before, immediately and 2 months after treatment. Method of measurement: Visual analogue scale ( VAS ). Neck disability index (NDI). Timepoint: Before, immediately and 2 months after treatment. Method of measurement: Neck disability Index questionnaire. Neck range of motion(ROM). Timepoint: bubble inclinometer. Method of measurement: Before, immediately and 2 months after treatment. Pressure pain threshold (PPT). Timepoint: Before, immediately and 2 months after treatment. Method of measurement: Algometer. Tabriz University of Medical Sciences Approved 2023-10-02 کمیته اخلاق دانشگاه علوم پزشکی تبریز Daneshgah Ave, executive field of Tabriz University of Medical Sciences, Vice-Chancellor for research of Tabriz University of Medical Sciences, University Ethics Committee Tabriz East Azarbaijan Iran (Islamic Republic of)