Effect of High-intensity Laser Therapy on Supraspinatus Tendon Elasticity

NCT ID: NCT06514105

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2025-03-03

Brief Summary

Subacromial impingement syndrome, one of the most common causes of shoulder pain. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.

Detailed Description

Subacromial impingement syndrome, one of the most common causes of shoulder pain, occurs when the supraspinatus tendon, subacromial bursa or bicipital tendon becomes compressed between the acromion, coracoacromial ligament, coracoid process and/or acromioclavicular joint during shoulder movements. Several factors contribute to subacromial impingement syndrome, including weakening of the rotator cuff, capsular tension, poor scapulohumeral rhythm, and muscular imbalance in the upward rotation force of the scapula. Steroid and non-steroidal anti-inflammatory agents, physiotherapy applications, laser therapy, manual therapy, ESWT and active and passive normal joint movements involving the shoulder joint are frequently applied treatments in the treatment of subacromial impingement syndrome.

It is stated that high-intensity laser treatment can quickly produce photochemical and photothermic effects in deep tissue. Therefore, collagen production in tendons is promoted and blood flow, vascular permeability and cell metabolism can be increased. As a result of all these processes, tissue healing begins and painful stimuli decrease. In studies investigating the effectiveness of high-intensity laser in patients with subacromial impingement syndrome, it was stated that high-intensity laser reduced the complaints of patients in the early and late periods. However, there is no research examining the effect of high-intensity laser on the supraspinatus tendon. Therefore, in this study, the investigators aimed to investigate the effect of high-intensity laser on the supraspinatus tendon using shear wave elastography.

Conditions

Subacromial Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High intensity laser group

In addition to the physiotherapy program, high intensity laser application will be applied to the high intensity laser group.

Group Type: ACTIVE_COMPARATOR

Physiotherapy program

Intervention Type: OTHER

All patients participating in the study will be included in the physiotherapy program. Physiotherapy program consist of hot-pack (for 15 minutes), ultrasound (Continuous ultrasound, for 5 minutes, 1-MHZ 1.5W/cm2, a 5-cm ultrasound head on the subacromial region),TENS (for 20 minutes with the BTL 4000 combined device) and exercise program (Stretching exercises for the rotator cuff, rhomboid muscles, levator scapula, serratus anterior and pectoaral muscles and strengthening the muscles around the shoulder with a resistance exercise band selected in a color appropriate to the patient's strength).

High intensity laser

Intervention Type: OTHER

High intensity laser will be applied using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area by making circular movements from the center to the outside for 100 seconds at a power of 10W and a dose of 10 J/cm2 (analgesic effect). The last 5 sessions will be applied to the painful area with linear movements at 4W power and 100 J/cm2 dose (biostimulation effect) for 10 minutes and 25 seconds.

Control group

In addition to the physiotherapy program, sham high intensity laser application will be applied to the control group.

Group Type: ACTIVE_COMPARATOR

Physiotherapy program

Intervention Type: OTHER

All patients participating in the study will be included in the physiotherapy program. Physiotherapy program consist of hot-pack (for 15 minutes), ultrasound (Continuous ultrasound, for 5 minutes, 1-MHZ 1.5W/cm2, a 5-cm ultrasound head on the subacromial region),TENS (for 20 minutes with the BTL 4000 combined device) and exercise program (Stretching exercises for the rotator cuff, rhomboid muscles, levator scapula, serratus anterior and pectoaral muscles and strengthening the muscles around the shoulder with a resistance exercise band selected in a color appropriate to the patient's strength).

Sham high intensity laser

Intervention Type: OTHER

In sham application, the patient will be positioned on the treatment stretcher and the device will be turned on. The guide light of the high-intensity laser device, which gives the same color as the laser light, will be applied to the subacromial region in circular movements from outside to inside and from inside to outside.

Interventions

Physiotherapy program

All patients participating in the study will be included in the physiotherapy program. Physiotherapy program consist of hot-pack (for 15 minutes), ultrasound (Continuous ultrasound, for 5 minutes, 1-MHZ 1.5W/cm2, a 5-cm ultrasound head on the subacromial region),TENS (for 20 minutes with the BTL 4000 combined device) and exercise program (Stretching exercises for the rotator cuff, rhomboid muscles, levator scapula, serratus anterior and pectoaral muscles and strengthening the muscles around the shoulder with a resistance exercise band selected in a color appropriate to the patient's strength).

Intervention Type: OTHER

High intensity laser

High intensity laser will be applied using the BTL-6000 (BTL Company, UK) device. The first 5 sessions will be applied to the painful area by making circular movements from the center to the outside for 100 seconds at a power of 10W and a dose of 10 J/cm2 (analgesic effect). The last 5 sessions will be applied to the painful area with linear movements at 4W power and 100 J/cm2 dose (biostimulation effect) for 10 minutes and 25 seconds.

Intervention Type: OTHER

Sham high intensity laser

In sham application, the patient will be positioned on the treatment stretcher and the device will be turned on. The guide light of the high-intensity laser device, which gives the same color as the laser light, will be applied to the subacromial region in circular movements from outside to inside and from inside to outside.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Shoulder pain lasting more than 6 weeks.
• Diagnosed with subacromial impingement
• Being between the ages of 30-60
• Volunteering to participate in the study

Exclusion Criteria

• Acute inflammatory disease affecting the shoulder area
• Presence of cervical radiculopathy
• Surgical intervention involving the shoulder and neck area
• Soft tissue or bone problems affecting the shoulder
• had any neurologic problems
• Patients who wish to withdraw from the study at any stage after volunteering

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adiyaman University

OTHER

Sponsor Role: lead

Responsible Party

Esin Akbas

Assistant Professor Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Esin Akbaş

Role: PRINCIPAL_INVESTIGATOR

Adiyaman University

Locations

Adiyaman university

Adıyaman, Adıyaman Province, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ADU-FTR-EA-01

Identifier Type: -

Identifier Source: org_study_id