Clinical trial NCT05335785: Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear
Official title: Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supraspinatus Tear
Keywords: shoulder
supraspinatus tear
rotator cuff tear
hiltherapy
lazer therapy
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 90 patients aged 20-60 years who were diagnosed with partial supraspinatus tear and met the inclusion criteria of the study will be included in the study. Patients will be randomized into three groups: 30 patients in the first group who have 5 sessions of high-intensity laser, 30 patients in the second group who have 10 sessions of high-intensity laser, and 30 patients in the third group control group who have only exercises. It was planned to give 5 sessions of laser+exercise every other day to the the first group, 10 sessions of laser+exercise every other day to the second group, and only exercise program three days in a week to the control group. All groups will be evaluated with joint range of motion (ROM) (measurements including abduction, adduction, flexion, extension, internal and external rotation by goniometer according to neutral 0 position), visual analog scale (VAS), shoulder pain dissability index, quickdash, constant score at 0th month, 1st month, 3rd and 6th months.

Eligibility criteria: Inclusion Criteria:

* age between 20-65 years
* Patients with VAS\>4 pain in the shoulder for at least 3 months
* Patients with at least 25% loss in the range of motion of the joint compared to the contralateral side, especially in abduction and external rotation, or on physical examination or positivity of at least one of the impingement tests including jobb, lift off, ERLS , speed, yergeson, O Brien's test, dropparm tests or popeye signs.
* Diagnose of partial supraspinatus with ultrasound or MR

Exclusion Criteria:

* Patients with incomplete skin integrity, hyperemia, signs of infection or tattoos
* Patients with suspected full-thickness tear
* History of rheumatic disease (rheumatoidarthritis, osteoarthritis, PMR)
* Patients with accompanying shoulder pathology such as calcifictendinitis
* History of malignancy
* Surgery, manipulation, mobilization, arthroscopy performed on the affected shoulder
* Steroid, local anesthetic, hyaluronic acid injection, cnesiotaping or neural therapy in the affected shoulder in the last 3 months
* Reflex sympathetic dystrophy, neurodeficit in the affected extremity
* Diabetes patients or any Patients who cannot feel the burning pain due to a peripheral neuropathy or sensory defect
* Patients with epilepsy

Primary outcomes:
measure: VAS (visuel analog score)
timeFrame: 3rd month
Secondary outcomes:
measure: Constant score
timeFrame: 6 th month
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
state: Karabaglar
Study officials:
affiliation: Katip Celebi University
name: Korhan Barış Bayram, assoc. prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.