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IRCT20180721040539N3 IRCT 2021-08-30 Babol University of Medical Sciences Comparing the Effects of High Intensity Laser, Hydrocortisone Phonophoresis and Ultrasound in Unilateral Subacromial Impingement Syndrome Patients Comparing the Effects of High Intensity Laser, Hydrocortisone Phonophoresis and Ultrasound on Pain, Range of Motion, Grip Strength, Upper Limb Function and Quality of Life in Unilateral Subacromial Impingement Syndrome Patients 2021-09-01 anticipated 60 Complete https://irct.ir/trial/57254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The simple randomization method will be used; Randomization list will be generated based on a computer program (Excel Office 2010) by a researcher who has no role in recruitment and evaluation process. Based on the results of randomization, the same researcher will be responsible for treating all patients belonging to each of the three groups of high intensity laser, hydrocortisone phonophoresis and ultrasound in all sessions, Blinding description: At first the patients will be visited by an Orthopedic specialist who will determine eligible participants based on inclusion and exclusion criteria and will referred them to a physiotherapy specialist who will evaluate the clinical outcomes. Then all eligible patients will be randomized and allocated into three treatment groups (HIL, Hydrocortisone phonophoresis and US) by a researcher who is not involved in recruitment and evaluation process. This same researcher will be responsible for treating all patients belonging to each of the three groups in all sessions. This researcher will not disclose the programmed intervention to the other researchers involved in the study until its final completion. Assessment of the outcomes at the end of the 10 treatment sessions and 1month follow-up will be performed by the same assessor who carried out the first evaluation. Eventually, collected data will be analyzed by a blind statistician. Thus assessor and statistician will be blinded throughout the study. 2 Unilateral Subacromial Impingement Syndrome. Intervention 1: Intervention group: HIL group: HIL will be applied using the Delta Laser New Age device (Italy) with a wavelength of 980 nm and 13 W maximum power output with probe diameter of 1 cm. The treatment will be consisted of three phases in each session. The initial phase will involve a peak power of 13 W, average power of 3/90 W, duty cycle 30% and 111 J energy. The intermediate phase will be applied a peak power of 13 W, average power of 6/5 W, duty cycle 50% and 1852 J energy. The final phase will be performed with a peak power of 13 W, average power of 3/90 W, duty cycle 30% and 111 J energy the same as the initial phase. HIL treatment will be included 15 min application time (each phase 5 min), and total energy of 4074 J in each session. Probe will be held in contact with the dry skin previously cleaned with alcohol, at 90 degree angle perpendicular to the On the anterior and superior surface of the shoulder joint in affected side. The hand piece will be moved slowly to the intended area. Intervention 2: Control group: Phonophoresis hydrocortisone group: An ultrasound device (215P Novin, Iran) will be used with a frequency of 1 MHz, an intensity of 1/2 watts per centimeter and a 60% duty cycle for 5 minutes on the anterior and superior surface of the shoulder joint. Hydrocortisone 1% gel will be used for phonophoresis. The probe is moved vertically, in full contact with the skin surface, in gentle circular motions lasting 3 seconds along each circular motion. Intervention 3: Control group: Ultrasound group: All conditions and settings of the device will be exactly the same as those mentioned in the use of phonophoresis, the difference is that instead of hydrocortisone 1% gel, non-therapeutic conductive gel is used to increase the absorption of waves. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet
public Pardis Norouzi
Babol University of Medical Science, Ganjafrouz Ave
Babol Iran (Islamic Republic of) 44176-47745 00981132199592-5 pardis.norouzi.pt@gmail.com Babol University of Medical Sciences scientific Seyyede Roghayeh Mousavi Khatir
Babol University of Medical Science, Ganjafrouz Ave
Babol Iran (Islamic Republic of) 44176-47745 00981132199592-5 r-mousavi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Aged 18-55 years Positive Neer and Hawkins tests in involved side Positive Empty can and Speed tests in involved side Painful range of motion active and passive abduction, flexion, internal rotation and external rotation of involved shoulder At least 4 weeks have passed since the onset of pain and symptoms on the involved side Resting pain score above 3 in the subacromial region of the involved side Confirmation of diagnosis of phase 1 and 2 subacromial impingement syndrome based on Neer criteria in MRI findings 18 years 55 years Both Radicular pain in involved upper limb Glenohumeral and acromioclavicular joint osteoarthritis History of shoulder surgeries history of acute trauma to the shoulder girdle History of humerus head fractures on the involved shoulder Frozen shoulder Thyroid diseases Heart disease and pacemaker Pregnancy Skin complications in the treated area Tumor Active cancer or a history of cancer less than one year after treatment Epilepsy Photosensitive diseases Mental illness Systemic and metabolic diseases Diabetes Presence of calcium deposition, complete or incomplete rupture in rotator cuff tendons and long head of biceps Fibromyalgia Physiotherapy or drug injections to reduce pain in the subacromial area at the same time as the study Rehabilitation Rehabilitation Rehabilitation Intervention group: HIL group: HIL will be applied using the Delta Laser New Age device (Italy) with a wavelength of 980 nm and 13 W maximum power output with probe diameter of 1 cm. The treatment will be consisted of three phases in each session. The initial phase will involve a peak power of 13 W, average power of 3/90 W, duty cycle 30% and 111 J energy. The intermediate phase will be applied a peak power of 13 W, average power of 6/5 W, duty cycle 50% and 1852 J energy. The final phase will be performed with a peak power of 13 W, average power of 3/90 W, duty cycle 30% and 111 J energy the same as the initial phase. HIL treatment will be included 15 min application time (each phase 5 min), and total energy of 4074 J in each session. Probe will be held in contact with the dry skin previously cleaned with alcohol, at 90 degree angle perpendicular to the On the anterior and superior surface of the shoulder joint in affected side. The hand piece will be moved slowly to the intended area. Control group: Phonophoresis hydrocortisone group: An ultrasound device (215P Novin, Iran) will be used with a frequency of 1 MHz, an intensity of 1/2 watts per centimeter and a 60% duty cycle for 5 minutes on the anterior and superior surface of the shoulder joint. Hydrocortisone 1% gel will be used for phonophoresis. The probe is moved vertically, in full contact with the skin surface, in gentle circular motions lasting 3 seconds along each circular motion. Control group: Ultrasound group: All conditions and settings of the device will be exactly the same as those mentioned in the use of phonophoresis, the difference is that instead of hydrocortisone 1% gel, non-therapeutic conductive gel is used to increase the absorption of waves. Pain at rest. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Visual Analog Scale. Pain while moving. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Visual Analog Scale. Shoulder active flexion range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder active abduction range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder active external rotation range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder active internal rotation range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder passive flexion range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder passive abduction range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder passive external rotation range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Shoulder passive internal rotation range of motion. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Standard plastic goniometer. Hand grip. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Dynamometer SEAHAN 5001. Upper limb function. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: Quick DASH questionnaire. Quality of Life. Timepoint: Prior to treatment initiation, at the end of the 10 treatment sessions and 1month after the completion of last treatment session. Method of measurement: SF-36 questionnaire. Babol University of Medical Sciences Approved 2021-05-08 Ethics committee of Babol University of Medical Sciences Babol University of Medical Science, Ganjafrouz Ave Babol Mazandaran Iran (Islamic Republic of)