Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear
Phase: NA
Conditions: Supraspinatus Tear
Sponsor: Izmir Katip Celebi University

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
                                                     RESEARCH  PROTOCOL 
 
 
EFFİCACY OF HİGH-İNTENSİTY LASER THERAPY İN PATİENTS WİTH PARTİAL 
SUPRASPİNATUS TEARS 
 
 
 
 
 
                                                                    PRIVACY NOTICE 
 
. This document is confidential and may not be printed or reproduced without the knowledge of the 
research team. 
 
 
 
 
 
 
1. ABSTRACT  
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.  
 
 
2. AIM and  PURPOSE 
 
Rotatorcuff lesions constitute 10% of the causes of shoulder pain. Supraspinatus tear is one of the common 
rotatorcuff lesions (1). It affects the quality of life negatively and causes loss of range of motion and muscle 
strength (2,3). 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 (3,4). Radiologically, classification is 
made as partial or full-thickness tears. Rotatorcuff tears can be treated conservatively or surgically (5). 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 (6) and high-intensity laser (7). The aim of 
this study is to reveal the effectiveness of high-intensity laser therapy in patients with partial supraspinatus tear. 
PRİMARY PURPOSE 
Demonstrating the efficacy of high-intensity laser therapy in patients with partial supraspinatus tears 
 
SECONDARY PURPOSE 
Comparison of two different applications of high-intensity laser with 5 sessions and 10 sessions in terms of 

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
effectiveness in patients with partial supraspinatus tear 
 
 
 
3.  HYPOTHESIS  OF THE STUDY 
 
H0: High-intensity laser therapy is ineffective in patients with partial supraspinatus tears. 
 
H1: High-intensity laser therapy is effective in patients with partial supraspinatus tears. 
 
 
 
4. SELECTION OF POPULATION & PATIENTS TO BE RESEARCHED 
 
Disease 
Partial supraspinatus tear 
Number of Patients & 
Characteristics 
 
women            Man            Age  20-65 
Healthy                 : 
Patient       :90 
Total             :     90 
 
Volunteers will be included in the study among the patients who applied to the FTR outpatient clinic and were 
diagnosed with a partial supraspinatus tear of the shoulder. 
 
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  

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
*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 
 
 Exclusion Criteria and Practices in this Case 
 
 
Patients will be excluded from the study if they do not attend follow-up and laser sessions regularly. 
 
 
5.  STUDY DESIGN & METHOD 
 
STUDY DESIGN 
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. 
  
 
DETAİLS of METHOD 
     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. 
     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. 
     30 patients will be included to control group. They will take only exercise program three times in a week. 
Description of Transactions on Working Days & Visits 
 
Patients diagnosed with partial supraspinatus tear on working days will be evaluated in the ftr outpatient clinic 
and suitable patients will be included in the study. Demographic information of the patients will be recorded. 
Consent will be obtained from the patients on the same day. Patients randomized to 3 groups will be included in 
the treatment protocol prescribed for each group at 0, 1, 3 and 6 month will be evaluated with VAS, shoulder 

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
pain dissability index, quickdash, constant score and  range of motion including abduction, adduction, flexion, 
extension, internal and external rotation by goniometer according to the neutral  position. 
 
Randomization 
After the subjects included in the study are informed about the study, they will be randomized into 3 groups 
according to their order of application. 
 
Blindness 
None 
Ensuring Patient Compliance 
 
Detailed information about the purpose of the study and its scientific contribution will be given to the patients 
and their relatives. Patients and their relatives will be informed that their names will be kept confidential. Parts 
that cannot be understood in the informed consent form will be explained in more detail. They will be informed 
that the study has the right to withdraw from the study at any time. 
 
 Materials to be Used & Storage Conditions & Responsibilities 
 
Thera band  will be used for the exercises. 
 
 
6. COLLECTION OF STUDY DATA 
 
Data Recording/ Case Report Forms 
 
A Case Report Form will be completed for each registered patient and signed by the responsible investigator or 
an authorized representative of the study staff. This also applies to enrollments for patients who did not 
complete the study (even during pre-randomisation screening, if a case report form was prepared). If a patient 
withdraws from the study, the reason for this will be recorded on the Case report form. If a patient is withdrawn 
from the study due to a treatment-limiting adverse event, every effort will be made to clearly document the 
outcome. All forms must be typewritten or filled with indelible ink and be legible. Errors can be crossed out, but 
errors cannot be erased; correction is entered and the change is initialed and dated by the researcher or his 
authorized representative. The investigator will ensure that the data reported to the sponsor in case report forms 
and all required reports are correct, complete, legible and processed in a timely manner. The researcher is 
responsible for the accuracy of the data transferred on the forms and will sign these forms to show their 
compatibility with the recorded data. 
 
 
7. SURGICAL PROCEDURES 
 
None 
 
8. PRECAUTIONS & WARNINGS FOR ENSURING PATIENT SAFETY 
 
In the physical therapy unit, there will be an emergency kit and healthcare personnel ready for intervention in 
terms of possible complications (hypotension, emergency cardiological conditions, skin reactions, burns, etc.) 
that may develop during treatment. During the application, the practitioner and the patient will have protective 

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
glasses. 
 
 
9. CONDITIONS TO STOP THE STUDY 
 
There is an unresolved malfunction in the device in the protocol 
  
 
10. STATISTICAL PROCEDURES 
 
Sample Size 
 
Sample size calculation was made using G*POWER 3.1.9 program. Using the findings of a similar study 
conducted before (6), it was predicted that a high level of effect size would be obtained between the groups 
(f=0.40) for the SPADI score of 22±1.2 for the 6th month before and after the treatment and 41.4±2.6 for the 
control group (f=0.40), 90% power, and type 1 error level: 5%, it is aimed to reach at least 84 people in total, 
and at least 90 people considering that there may be losses in the follow-up. 
 
 
Statistical & Analytical Methods 
 
The data will be analyzed with the SPSS 18.0 package program. GraphPad for Windows will be used in the 
randomization process. Continuous variables will be presented as mean and standard deviation or median (25p-
75p). Categorical variables will be presented as percentages. The conformity of the data to the normal 
distribution will be evaluated with the Shapiro Wilk test. Analysis of variance (ANOVA) and split-mixed 
ANOVA will be used in the analysis of within-group changes and in repeated measures of significance between 
the differences between groups. Tukey and Games Howell tests will be used in post-hoc tests. 
 
 
11. ETHICAL & LEGAL REQUIREMENTS & QUALITY ASSURANCE 
 
Informing Patients and Informed Consent 
 
Consent will be obtained from patients acording to Helsınkı declaratıon. 
Ensuring Confidentiality 
 
The investigator will ensure that the names of the patients are kept confidential and that the identities of the 
individuals are protected from unauthorized parties, that the patients will be identified only by the initials of the 
name-surname and randomization number on the Case Report Form; It will be explained that any document that 
identifies the patient will be kept in complete confidentiality by the principal investigator, and that the 
investigator may authorize appropriate legal authority(s) to review patients' files in line with Good Clinical 
Practices and legal requirements. 
 
Protocol Changes and Approval of Changes 
 

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
All protocol adjustments will not be made without the approval of the local ethics committee for any regulation 
that may affect the safety of patients or the conduct of the study, prior to the implementation of any changes to 
the protocol. 
 
 
 
Records Retention and Quality Assurance Measures 
 
The records will be saved on our encrypted computer and the patient's privacy will be protected by deleting the 
data after it is used for scientific purposes. 
 
Financial and Criminal Liability 
 
It will be stated that the expenses of non-routine procedures and in cases where the patient is harmed within the 
scope of the trial, the costs will be covered by the sponsor, and in case of going out of the protocol of the study, 
the financial and penal responsibility belongs to the responsible investigator. 
 
 
 
- 
 
13. REFERENCES 
1. Meislin RJ, Sperling JW, Stitik TP. PersistentShoulderPain: 
epidemiology,pathophysiologyanddiagnosis. Am J Orthop, 2005;34(12):5-9. 
2. Bayram K.B, Bal S, Satoglu I.S, Kocyigit H, Gurgan A, Akcay S, Kazimoglu C. 
DoesSuprascapularNerveBlockImproveShoulderDisability in 
ImpingementSyndrome? A RandomizedPlacebo-ContolledStudy.Journal of 
Musculoskeletal Pain,2014;22(2): 170–174. 
3. Boilaeu P, Brassart N, Watkinson DJ et al. Arthroscopicrepair of full-ticknesstears of 
thesupraspinatus: doesthetendonrealyheal? J Bone JointSurg Am. 2005;87:1229-1240. 
4. Alexander WA, Robert HB. Outcomes of rotatorcuffsurgery.Clinical Sports Medicine. 
2012;31: 665-674. 
5. Taiceer A. Abdul-Wahab, Jean P. Betancourt, Fadi Hassan, Saeed Al. Thani, 
HenedChoueiri, Nitin B. Jain, Gerard A. Malanga, Wiliam D. Murrell, AnilPrasad, 
OliverVerborgt.Initialtreatment of 
completerotatorcufftearandtransitiontosurgicaltreatment: systematicreview of 
theevidence. Muscles, LigamentsandTendonsJournal, 2016;6(1):35-47. 
6. Elsodany 
AM, Alayat 
MSM, Ali 
MME, Khaprani 
HM. 
Long-
Term Effect of Pulsed Nd: YAG Laser in theTreatment of Patients with Rotator Cuff 
Tendinopathy: A RandomizedControlled Trial.   PhotomedLaserSurg. 2018 
Sep;36(9):506-513. 
7. Sturla H, Liv Heide M, Jon J et al. The Efficacy of Low‐Level Laser Therapy for 
Shoulder Tendinopathy: A Systematic Review and Meta‐Analysis of Randomized 
Controlled Trials.Physiother Res Int. 2015 June; 20 (2): 108-25. 
 
 

Protocol name/ version number /date: Efficacy of high-intensity laser therapy in patients with partial 
supraspinatus tears 
Versiyon no: 02 -Tarih: 02.12.2020 
 
 
 
 
 
 
 
 
 
 
 
 
Date/ Sıgnature 
02.12.2020 
RESPONSIBLE RESEARCHER