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IRCT20180728040618N5 IRCT 2021-08-01 Iran University of Medical Sciences The effectiveness of traditional physiotherapy and High-Tone therapy vs. routine physiotherapy alone on trigger point in upper trapezius muscle The effectiveness of traditional physiotherapy and High-Tone therapy vs. routine physiotherapy alone on pain, cervical ROM, disability level and quality of life in chronic non-specific neck pain subjects with trigger point in upper trapezius muscle 2021-07-16 anticipated 30 Complete https://irct.ir/trial/57292 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with nonspecific chronic neck pain are randomly divided into two groups: routine physiotherapy and high-tone therapy (group A) and routine physiotherapy group alone (B) with a ratio of 1:1. Random allocation will be done by the method of balanced (permuted) block randomization, which consists of 4-letter blocks and are made of letters A and B. Then, the treatment allocation list obtained in letters A and B is placed inside the numbered envelopes. The letter A stands for routine physiotherapy and high-tone therapy, and the letter B denotes routine physiotherapy alone. The random assignment process is performed by someone outside the research team before the study begins. Block randomization tool will be done by Random allocation software. After the initial evaluation of the patient by the examiner, the envelopes will be numbered according to the number of each person entered in the study. Finally, after each patient enters the treatment sessions, the intervention provider adjusts the treatment interventions based on the letters in the envelope, Blinding description: The assessor will be completely unaware of the letters inside the envelopes at the random assignment stage. It should also be noted that after placing patients in the desired group, they are asked not to provide their grouping information to the assessor. All assessments will be performed by a physiotherapist. This person does not know the grouping of patients with chronic non-specific neck pain. In other words, at the time of the final evaluation of the patients, the assessor is not able to determine what type of treatment each patient has received. Therapeutic interventions will be performed by another physiotherapist. N/A Chronic non-specific neck pain. Intervention 1: Intervention group: Individuals with non-specific chronic neck pain who are in the routine physiotherapy and hightone therapy groups receive the same routine physiotherapy protocol twice a week for 4 weeks. In addition, individuals in the experimental group treated with hightone therapy. This study uses hightone currents with HITOP device (manufacturer: GBO Country of manufacture: Germany), which produces currents with a pulse width of less than 350 mA and less than 70 volts. The current starts with an initial frequency of 4096 Hz and reaches a frequency of 32768 Hz in more than 3 seconds. At frequency 32768, the current is maintained for a maximum of 3 seconds and then returns to the base frequency, and the intensity of the current increases to such an extent that the person does not feel pain or discomfort. Individuals in the experimental group receive Hightone currents for 20 minutes per session, twice a week for 4 consecutive weeks. Intervention 2: Control group: Individuals with chronic non-specific neck pain who are placed in the routine physiotherapy group alone receive the following protocol twice a week for 4 weeks.1- Heat (using infrared light for 10 minutes at the beginning of treatment) 2- Acupuncture-like current (TENS) (due to chronic pain) with a frequency below 10 Hz, pulse duration 150-250 microseconds. Four electrodes (two channels) are placed on the neck area and the sore spot of the trigger points for 15 minutes. 3- Ischemic pressure technique on trigger points: To apply this technique, the person is placed in a prone position and the upper trapezius muscle is placed in a shortened position. This technique involves continuous deep pressure using the thumb, which gradually increases to the patient's tolerance threshold. The pressure is relieved when either a tissue release is felt under the contraction or it lasts more than 60 seconds. This technique is applied 3 times per session for each trigger point with a 10 second rest interval. 4- Upper Trapezius Muscle Stretching Training: To stretch the each side of upper trapezius muscle, asked while sitting facing on chair, to bend the neck forward, and lateral flex to the opposite side, and rotate towards the affected. People are asked to do this exercise three days a week, 2 times a day, 10 repetitions each time, and 30 seconds for the involved side. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary When: Starting 6 months after publication To whom: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders Conditions: The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of hightone current and trigger points of upper trapzius muscle. Where to obtain: Applicants can contact the researcher of this study Zamane bonyatpour by email. Email address: zamane94@gmail.com How to obtain: Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days. Comments:
public Holako Mohsenifar
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 8670 2504 Mohsenifarpt@gmail.com Iran University of Medical Sciences scientific Holako Mohsenifar
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran St, Shah Nazari St, Madar Sq, Mirdamad Blvd, Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 Mohsenifarpt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patient with chronic non-specific neck pain Age between 20 to 50 years old Ability to read and write in Persian 20 years 50 years Both Specific neck pain History of migraine Peripheral nerve involvement in shoulder and neck region Existence of fractures in the spine Existence of tumor in the spine Existence of musculoskeletal disorders in shoulder region M54.2 Cervicalgia Treatment - Other Treatment - Other Intervention group: Individuals with non-specific chronic neck pain who are in the routine physiotherapy and hightone therapy groups receive the same routine physiotherapy protocol twice a week for 4 weeks. In addition, individuals in the experimental group treated with hightone therapy. This study uses hightone currents with HITOP device (manufacturer: GBO Country of manufacture: Germany), which produces currents with a pulse width of less than 350 mA and less than 70 volts. The current starts with an initial frequency of 4096 Hz and reaches a frequency of 32768 Hz in more than 3 seconds. At frequency 32768, the current is maintained for a maximum of 3 seconds and then returns to the base frequency, and the intensity of the current increases to such an extent that the person does not feel pain or discomfort. Individuals in the experimental group receive Hightone currents for 20 minutes per session, twice a week for 4 consecutive weeks. Control group: Individuals with chronic non-specific neck pain who are placed in the routine physiotherapy group alone receive the following protocol twice a week for 4 weeks.1- Heat (using infrared light for 10 minutes at the beginning of treatment) 2- Acupuncture-like current (TENS) (due to chronic pain) with a frequency below 10 Hz, pulse duration 150-250 microseconds. Four electrodes (two channels) are placed on the neck area and the sore spot of the trigger points for 15 minutes. 3- Ischemic pressure technique on trigger points: To apply this technique, the person is placed in a prone position and the upper trapezius muscle is placed in a shortened position. This technique involves continuous deep pressure using the thumb, which gradually increases to the patient's tolerance threshold. The pressure is relieved when either a tissue release is felt under the contraction or it lasts more than 60 seconds. This technique is applied 3 times per session for each trigger point with a 10 second rest interval. 4- Upper Trapezius Muscle Stretching Training: To stretch the each side of upper trapezius muscle, asked while sitting facing on chair, to bend the neck forward, and lateral flex to the opposite side, and rotate towards the affected. People are asked to do this exercise three days a week, 2 times a day, 10 repetitions each time, and 30 seconds for the involved side. Pain. Timepoint: Before the intervention and 4 weeks after the last treatment session. Method of measurement: visual analog scale. Neck range of motion. Timepoint: Before the intervention and 4 weeks after the last treatment session. Method of measurement: guniameter. Neck disability. Timepoint: before the intervention and 4 weeks after the last treatment session. Method of measurement: neck disability index questionnaire. Quality of life. Timepoint: before the intervention and 4 weeks after the last treatment session. Method of measurement: quality of life questionnaire SF-36. Iran University of Medical Sciences Approved 2021-06-28 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)