Effect of High-intensity Laser Therapy on Supraspinatus Tendon Elasticity

NCT06514105 | Completed

• 1 other identifier: ADU-FTR-EA-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Keywords

Elasticity Imaging Techniques; Physical Therapy Modalities; Rotator Cuff

Outcome Measures

Primary Outcomes (1)

• Elasticity Measurement

  In patients diagnosed with subacromial impingement syndrome as a result of physical examination, the degree of elasticity of the supraspinatus tendon and supraspinatus muscle on the relevant side will be evaluated numerically by Shear Wave elastography. All patients will be scanned by an expert radiologist using a high-resolution broadband linear probe with a Samsung RS 85 Prestige device. While the patients are sitting comfortably and the arm is in a neutral position, the linear probe will be placed parallel to the supraspinatus tendon and the tendon will be displayed in the longitudinal direction. Velocity and elasticity values of the muscle in kPa will be measured using 3 mm diameter range of interest (ROIs) with the help of Shear Wave elastography in the supraspinatus tendon at a distance of 0.5-1.5 cm from the tuberculum majus. For each patient, the measurement will be repeated three times and the average of these three values will be recorded.

  2 weeks

Secondary Outcomes (2)

• Functional level

  2 weeks

• Pain assessment

  2 weeks

Study Arms (2)

High intensity laser group

ACTIVE COMPARATOR

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

Other: Physiotherapy program; Other: High intensity laser

Control group

ACTIVE COMPARATOR

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

Other: Physiotherapy program; Other: Sham high intensity laser

Interventions

Physiotherapy program 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).

Control group; High intensity laser group

High intensity laser 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.

High intensity laser group

Sham high intensity laser 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.

Control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adiyaman University: lead

Study Sites (1)

Adiyaman university

Adıyaman, Adıyaman Province, 02000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Esin Akbaş

  Adiyaman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be done by the physiotherapist who applies the physiotherapy program and high-intensity laser. The patient, the measuring radiologist, and the investigator will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr

Model Details: The study was planned as double-blind, randomized controlled. There are two groups in the study. The groups consist of the control group and high intensity laser group.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 23, 2024
• Study Start: July 22, 2024
• Primary Completion: February 17, 2025
• Study Completion: March 3, 2025
• Last Updated: July 10, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)