Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Supraspinatus Tear
• Intervention / Treatment: Device: High-intensity lazer therapy; Other: Exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karabaglar
    • Izmir, Karabaglar, Turkey, 35360
      • Izmir Katip Celebi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 5 session lazer therapy; 30 patients will be included to 5 session lazer therapy group. They will take totally 5 sessions of high-intensity laser every other day.	Device: High-intensity lazer therapy; 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.
ACTIVE_COMPARATOR: 10 session lazer therapy; 30 patients will be included to 10 session lazer therapy group. They will take totally 10 sessions of high-intensity laser every other day.	Device: High-intensity lazer therapy; 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.
OTHER: control group; 30 patients will be included to control group. They will take only exercise program three times in a week.	Other: Exercises; Exercise program including Codman, Range of motion and streightening exercises three times in a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant score	The Constant score (CS) is one of the most frequently applied tools for the assessment of the shoulder joint.The Constant score is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient	6 th month

Collaborators and Investigators

• Sponsor: Izmir Katip Celebi University
• Investigators: Study Director: Korhan Barış Bayram, assoc. prof., Katip Celebi University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 2, 2020
• Primary Completion (ANTICIPATED): December 2, 2022
• Study Completion (ANTICIPATED): December 2, 2023

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (ACTUAL): April 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: rotator cuff tear; shoulder; supraspinatus tear; hiltherapy; lazer therapy
• Other Study ID Numbers: IzmirKCU*

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol will be shared for first 6 months after the study finish results and statisitcs will be shared.
• IPD Sharing Time Frame: when the study start and data will be avaliable for 6 months
• IPD Sharing Access Criteria: study protocol will be shared for first 6 months after the study finish results and statisitcs will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No