Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

Izmir Katip Celebi University

Status: Unknown

Conditions: Supraspinatus Tear

Treatments: Other: Exercises; Device: High-intensity lazer therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05335785

IzmirKCU*

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

5 session lazer therapy

Active Comparator group

Description:

30 patients will be included to 5 session lazer therapy group. They will take totally 5 sessions of high-intensity laser every other day.

Treatment:

Device: High-intensity lazer therapy

10 session lazer therapy

Active Comparator group

Description:

30 patients will be included to 10 session lazer therapy group. They will take totally 10 sessions of high-intensity laser every other day.

Treatment:

Device: High-intensity lazer therapy

control group

Other group

Description:

30 patients will be included to control group. They will take only exercise program three times in a week.

Treatment:

Other: Exercises