Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

Supraspinatus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05335785
• Other study ID #: IzmirKCU*
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: December 2, 2023

Study information

• Verified date: April 2022
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: December 2, 2023
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Supraspinatus Tear

Intervention

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:
• Exercises
Exercise program including Codman, Range of motion and streightening exercises three times in a week.

Locations

Country	Name	City	State
Turkey	Izmir Katip Celebi University	Izmir	Karabaglar

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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