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IRCT20240207060929N1 IRCT 2024-02-26 Walailak university Comparison of the Effectiveness of Radial Extracorporeal Shockwave Therapy Versus High Intensity Laser Therapy in Patients With Myofascial Pain Syndrome of Upper Trapezius Muscle Comparison of the Effectiveness of Radial Extracorporeal Shockwave Therapy Versus High Intensity Laser Therapy in Patients With Myofascial Pain Syndrome of Upper Trapezius Muscle 2024-03-01 anticipated 69 Complete https://irct.ir/trial/75436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The sample size was determined using G*Power. The means and standard deviations were derived from a previous study, with the values being Mean±SD = 6.56 ± 2.06 and 6.46 ± 1.84, respectively. The calculated effect size was 0.46, resulting in a total of 58 participants, with an additional allowance for a 15% dropout rate. Consequently, the total number of participants in this study amounted to 69 (comprising 23 participants per group), Randomization description: Stratified Randomization with matched pairs of variables, including age, gender, and BMI. Subsequently, computer software is employed as the tool for randomization, Blinding description: This study employs a double-blind method for both participants and outcome assessors. Once participants are randomized into groups, they are scheduled for treatment sessions at different times for each group. Furthermore, the outcome assessor, who is a physiotherapist unaware of the participant's group allocation, conducts baseline and post-treatment measurements. Another physiotherapist, who is responsible for overseeing the study, performs participant randomization into groups and administers the interventions. 1-2 Myofascial pain syndrome at Upper trapezius muscle. Intervention 1: Intervention group 1: Participants in the Shockwave group will receive 2,000 shocks, consisting of 1,000 shocks at 1.5 bars with a frequency of 15 Hz at trigger points, and 1,000 shocks at 2 bars with a frequency of 8 Hz around the trigger point, with treatments conducted once a week. The total duration of treatment for all groups is 4 weeks. Intervention 2: Intervention group 2: Participants in the High-intensity Power Laser group will be treated with lasers of wavelengths 810 nm and 980 nm, at a power of 7 watts, also once a week. The total duration of treatment for all groups is 4 weeks. Intervention 3: Control group: Participants in the Control group, as well as those in all other groups, will perform stretching exercises daily and record data in a log book. The total duration of treatment for all groups is 4 weeks. Yes - There is a plan to make this available What will be shared: Data will be collected for the primary outcome measure only and all collected de-identified. When: Personal information of research project participants will be kept confidential and will not be publicly disclosed individually. A consolidated report will be generated, and all documents will be starting in March 2024 and securely destroyed by January 2028. To whom: The personal data of research participants will be collected on encrypted computers inaccessible to individuals not involved in the study. The researcher will anonymize information for academic purposes. Conditions: The personal data of research participants will be collected on encrypted computers inaccessible to individuals not involved in the study. The researchers will analyze the results using the SPSS program, which is an offline application. Where to obtain: Researchers will communicate with participants via telephone. Postal or email addresses, website URLs, and fax numbers are not required for this study. Data files will be treated as confidential and will not be disclosed publicly on an individual basis. A consolidated report will be produced, and all documents will be securely destroyed by January 2028. How to obtain: The data supporting the findings of this study are available from the corresponding author upon reasonable request. However, access will be provided only for the primary outcome measure and data that cannot be personally identified. Comments:
public Sirinthip Pakdee
222 Thaiburi
Thasala Thailand 80160 +66 75 672 611 Sirinthip.pa@wu.ac.th Walailak University scientific Kanruethai Threesittidath
222 Thaiburi
Thasala Thailand 80160 66756702645 kanruethai.si@wu.ac.th Walailak University Thailand A student aged between 18-24 years Diagnosed with Myofascial pain syndrome of the Upper trapezius muscle Duration of pain is equal to or more than 3 months Severity of pain during the day is equal to or more than 3 out of 10 (pain scale ≥ 3/10) 18 years 24 years Both Use of medication such as anti-coagulants, pain relievers, and anti-inflammatories History of cancer Current infection or wound in the area requiring treatment Patient with a pacemaker History of easy bleeding Pregnant Diagnosed by a physician with a mental disorder such as depression Vigorous exercise or physical activity Experienced trauma in the neck area affecting the function of the upper trapezius muscle, such as wounds, fractures, or whiplash injuries Currently undergoing treatment for pain in the upper trapezius muscle area M79 Other and unspecified soft tissue disorders, not elsewhere classified Treatment - Devices Treatment - Devices Other Intervention group 1: Participants in the Shockwave group will receive 2,000 shocks, consisting of 1,000 shocks at 1.5 bars with a frequency of 15 Hz at trigger points, and 1,000 shocks at 2 bars with a frequency of 8 Hz around the trigger point, with treatments conducted once a week. The total duration of treatment for all groups is 4 weeks. Intervention group 2: Participants in the High-intensity Power Laser group will be treated with lasers of wavelengths 810 nm and 980 nm, at a power of 7 watts, also once a week. The total duration of treatment for all groups is 4 weeks. Control group: Participants in the Control group, as well as those in all other groups, will perform stretching exercises daily and record data in a log book. The total duration of treatment for all groups is 4 weeks. Pain symptoms at upper trapezius muscle. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Pain symptoms will be assessed using a Pressure Algometer, with participants indicating their level of pain on the Visual Analog Scale (VAS). Muscle length of the Upper trapezius muscle. Timepoint: Before intervention and 1, 2, 3, 4 weeks after intervention. Method of measurement: Muscle length will be measured using tape measurement, with assessment points located between the Spinous process of C7 and the Distal end of the acromion process. This measurement will be taken during neck flexion combined with lateral flexion to the opposite side and rotation to the same side. Range of motion of the neck. Timepoint: Before intervention and 1, 2, 3, 4 weeks after intervention. Method of measurement: Measurements will be conducted using a cervical range of motion device. The starting position will be seated in a chair. From this position, the degree of neck flexion, neck extension, lateral flexion of the neck, and neck rotation will be measured. Neck function. Timepoint: Before intervention and 1, 2, 3, 4 weeks after intervention. Method of measurement: The Neck Disability Index (NDI) comprises 10 questions covering the following areas: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleep, and Recreation. Each question offers six choices, with scores ranging from 0 to 5. A score of 0 indicates no pain or interference with activity, while a score of 5 signifies very severe pain or extreme disruption, to the point of being unable to perform the activity. The total possible score for the NDI assessment ranges from 0 to 50 points. Frequency of pain. Timepoint: Before intervention and 1, 2, 3, 4 weeks after intervention. Method of measurement: A questionnaire will be utilized to investigate the frequency of pain. No funding Approved 2024-01-12 Ethic Committee in Human Research Walailak University 222 Thaiburi Thasala Nakhon Si Thammarat Thailand