NCT05335785|Unknown
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Sponsor study identifier
interventional
90
1 country
1
Study Start
December 2, 2020
Actual (reported)Primary Completion
December 2, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rotatorcuff lesions constitute 10% of the causes of shoulder pain. Supraspinatus tear is one of the common rotatorcuff lesions. It affects the quality of life negatively and causes loss of range of motion and muscle strength. It can be seen due to traumatic or degenerative causes. Its incidence increases with advanced age. While the incidence was reported as 4% in the population aged 40-60 years, this rate was reported to be 17-50% in the group over the age of 60 and 80% in the group over the age of 80. Radiologically, classification is made as partial or full-thickness tears. Rotatorcuff tears can be treated conservatively or surgically. Although the risk of post-surgical rupture is reduced with new methods, the lack of desired tendon healing has led to the search for alternative applications such as biological augmentation and high-intensity laser. The aim of this study is to reveal the effectiveness of high-intensity laser therapy in patients with partial supraspinatus tear.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2, 2020
Actual (reported)March 8, 2022
Actual (reported)April 19, 2022
Actual (reported)December 2, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
VAS (visuel analog score)
evaluation of pain with scale of between 0 and 10 that means 0 no pain and 10 too much pain.
3rd month
Constant score
6 th month
30 patients will be included to 5 session lazer therapy group. They will take totally 5 sessions of high-intensity laser every other day.
30 patients will be included to 10 session lazer therapy group. They will take totally 10 sessions of high-intensity laser every other day.
30 patients will be included to control group. They will take only exercise program three times in a week.
Patients in the laser group will be given hiltherapy (high-intensity laser) with the HIRO 3 device every other day. One session of laser therapy application consists of 3 phases: the beginning, the middle and the ending phase. The initial phases are fast scanning and the ending phase is slow scanning. A total of 2000 J will be applied to the rotatorcuff muscles, the upper part of the trapezius muscle, the deltoid muscle and the pectoralis major muscle, 1000 J in the rapid scan phase and 1000 J in the finishing phase. In the middle phase, 50 J will be applied for the trigger point (hard intramuscular points that cause referred pain) in each muscle and a maximum of 500 J in total. The total dose prescribed for patients in one session will be 2500 J. Each phase will be 15 minutes on average and the session will last for 45 minutes in total. The laser probe will be applied with 90 degrees. During the application, the practitioner and the patient will have protective glasses.
Izmir Katip Celebi University
Izmir, Karabaglar, 35360, Turkey (Türkiye)
Meislin RJ, Sperling JW, Stitik TP. Persistent shoulder pain: epidemiology, pathophysiology, and diagnosis. Am J Orthop (Belle Mead NJ). 2005 Dec;34(12 Suppl):5-9.
Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
Korhan Barış Bayram, assoc. prof.
Katip Celebi University
First Submitted
March 8, 2022
First Posted
April 19, 2022
Study Start
December 2, 2020
Actual (reported)Primary Completion
December 2, 2022
Treatment of the Biceps With Concomitant Supraspinatus Tears
Exercise program including Codman, Range of motion and streightening exercises three times in a week.
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Elsodany AM, Alayat MSM, Ali MME, Khaprani HM. Long-Term Effect of Pulsed Nd:YAG Laser in the Treatment of Patients with Rotator Cuff Tendinopathy: A Randomized Controlled Trial. Photomed Laser Surg. 2018 Sep;36(9):506-513. doi: 10.1089/pho.2018.4476.
Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.
Aleem AW, Brophy RH. Outcomes of rotator cuff surgery: what does the evidence tell us? Clin Sports Med. 2012 Oct;31(4):665-74. doi: 10.1016/j.csm.2012.07.004.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 19, 2022
Record last verified: 2022-04
study protocol will be shared for first 6 months after the study finish results and statisitcs will be shared.
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Source: ClinicalTrials.gov.
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