Effectiveness of High Intensity Laser Treatment In Partial Supraspinatus Tendon Tears (HILT)

October 12, 2024 updated by: Oznur Uzun, Ankara City Hospital Bilkent

Effectiveness of High Intensity Laser Treatment in Partial Supraspinatus Tendon Tears: A Randomised Controlled Trial

The primary goal of this clinical trial is to compare the effects of High Intensity Laser Therapy (HILT) on tears of tendons of shoulder girdle muscles with those of Ultrasound (US) therapy. It will also learn about the effects of HILT on pain and range of motion of injured shoulder. The main questions it aims to answer are:

Does HILT decrease the debilitating pain? Does HILT increase the range of motion of the sholuder joint? How long does the effect of HILT continue?

Researchers will compare the effects of HILT to a control group (ultrasound therapy group, an established method of treatment in shoulder girdle tendon tears) to see if HILT works better to treat shoulder girdle tendon tears.

Participants will:

receive HILT or US therapy 3 sessions per week for 3 weeks in addition to the therapeutic exercise program.

Visit the clinic at the beginning, at the 4th week and at the 12th week to determine the level of pain and disability via application of surveys.

Tendon thickness of participants will also be measured at the beginning, at the 4th week and at the 12th week to see if the treatment works to heal the tear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Shoulder disorders are one of the most common musculoskeletal problems worldwide. After low back pain and knee pain, shoulder pain has been estimated to be the third most common musculoskeletal presentation in primary care. Shoulder joint is surrounded by rotator cuff muscles and rotator cuff tendinopathy is the most common cause of shoulder pain. Shoulder pain caused by partial supraspinatus tendon tear (STT) is a complex and challenging issue for clinicians. The choice of the most appropriate treatment management for these tears is controversial.

For Ellman grade I and II tears which comprise STTs of less than 50% or tears which are below 6 mm in thickness, strengthening exercises, ultrasound (US) therapy, physical therapy, injection treatment and medical treatment can provide improvement in patients. However, in grade III tears which involve STTs of more than 50% of the muscle or tears above 6 mm in thickness surgical treatment may be required.

Recently, high-intensity laser therapy (HILT) has been introduced and used in treatment of musculoskeletal disorders. There is no universally accepted theory that explains the exact mechanism of the postulated laser effects, yet. Nd:YAG laser which has a wavelength of 1064 nm is used in HILT. It works in a therapeutic window that has a low absorbability rate in superficial tissue layers, so it penetrates more deeply than other types of lasers. In addition to having a higher power than low-intensity lasers, lasers used in HILT have a shorter laser emission time and a longer laser emission interval. Therefore, a large amount of laser irradiation can be delivered to deep tissues. The utilization of HILT has been expanding, and patients have reported significant improvement in function and reduction of pain.

To our knowledge, no studies to date have been conducted on the effects of HILT on partial STT. The aim of the present study was to evaluate the long-term effectiveness of HILT on pain, disability, and range of motion in patients with shoulder pain caused by STT and to compare its effects to those of US therapy.

The current study was designed as a prospective randomized controlled clinical trial and conducted after approval from the local ethics committee of our medical center. The study was conducted in accordance with the principles of Declaration of Helsinki and registered in the government database. The patients were recruited from the Ankara Bilkent City Hospital, physical medicine and rehabilitation outpatient clinic

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • to be between 18-75 years old,
  • the presence of shoulder pain for more than 3 months
  • shoulder pain level of at least 3 on a 10-point Visual Analog Scale
  • diagnosis of partial STT's which are below 6 mm in thickness
  • no response to conservative treatments such as ice, soft tissue massage, stretching and nonsteroidal anti-inflammatory (NSAID) drugs after 6 weeks.

STT was detected with musculoskeletal system ultrasound by the same physician in outpatient clinic.

Exclusion Criteria:

  • inflammatory rheumatic disease,
  • cervical radiculopathy
  • pregnancy,
  • thyroid disease,
  • history of cardiac pacemaker placement,
  • epilepsy and/or any progressive neurological disease,
  • history of shoulder surgery
  • shoulder injection within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HILT (HILT Group)
HILT group received HILT 3 sessions per week for 3 weeks in addition to the therapeutic exercise program applied 5 sessions per week for 3 weeks. HILT was performed by a single physiotherapist experienced in using a laser device. In the HILT group, the device was used on the rotator cuff muscles in two stages: phase I and phase II. Pulse method was used in phase I for analgesic effect. For the biostimulation effect, the continuous wave method was used in phase II. In the next five sessions, biostimulation effect was applied using 7W power. A dose of 100 J/cm was applied longitudinally to the rotator cuff muscles area for a total energy of 2500 J for 25 minutes and 57 seconds up to 25 cm.
Device: High intensity laser therapy
HILT was performed by a single physiotherapist experienced in using a laser device. During HILT application, the patients were seated comfortably on chairs and their shoulders were in neutral position. The wavelength of the laser light used was 1064 nanometers. In the HILT group, the device was used on the rotator cuff muscles in two stages: phase I and phase II. Pulse method was used in phase I for analgesic effect. A standard frequency of 25 Hz is applied. During the first four therapy sessions, it was aimed to provide an analgesic effect by using 8 W power and 12 J/cm dose. The rays were applied to the rotator cuff muscles area in a circle from outside to inside for 2.5 minutes, for a total energy of 300 J, on an area of 25 cm2. For the biostimulation effect, the continuous wave method was used in phase II. n the next five sessions, biostimulation effect was applied using 7W power. A dose of 100 J/cm was applied longitudinally to the rotator cuff muscles.
Other: Therapeutic Exercise
ROM exercises and Codman exercises, in a level not to increase the severity of the pain of the patient, were given and stretching and strengthening exercises were taught to the patients. They performed these exercises daily in two sets with five repeats in each set underCalibration and control of the device are performed regularly.
Active Comparator: Ultrasound therapy (US Group)
Ultrasound therapy was performed by a single physiotherapist experienced in using US device. US group received an ultrasound program 3 days a week in addition to a therapeutic exercise program of 5 sessions per week for 3 weeks. During US therapy, the patients were seated comfortably on chairs and their shoulders were in neutral position. The standard US dose was 1.2 W/cm2. The duration of ultrasound was 8 minutes. Using slow circular movements, the physiotherapist applied the transducer head of US device over the shoulder joint on an area of 25 cm2. US device was used in pulsed mode at a frequency of 1 MHz. The therapeutic ultrasound pulse cycle was 50%.
Device: Ultrasound therapy
US therapy was performed by a single physiotherapist experienced in using US device. Calibration and control of the device are performed regularly. During US therapy, the patients were seated comfortably on chairs and their shoulders were in neutral position. The standard US dose was 1.2 W/cm2. The duration of ultrasound was 8 minutes. Using slow circular movements, the physiotherapist applied the transducer head of US device over the shoulder joint on an area of 25 cm2. US device was used in pulsed mode at a frequency of 1 MHz. The therapeutic ultrasound pulse cycle was 50%.
Other: Therapeutic Exercise
ROM exercises and Codman exercises, in a level not to increase the severity of the pain of the patient, were given and stretching and strengthening exercises were taught to the patients. They performed these exercises daily in two sets with five repeats in each set underCalibration and control of the device are performed regularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) for pain
Time Frame: VAS for pain was applied to the patients before the procedure and at the 4th week and the 12th week after the procedure.
VAS is used to measure musculoskeletal pain with very good reliability and validity (VAS, 0-10 cm; 0 means no pain, 10 means severe pain).
VAS for pain was applied to the patients before the procedure and at the 4th week and the 12th week after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: SPADI) was applied to the patients before the procedure and at the 4th week and 12th week after the procedure.

Shoulder Pain and Disability Index (SPADI) was developed to measure shoulder discomfort. Its evaluation includes two parts: pain and disability. Part 1 includes five questions in the pain subgroup and measures the pain experienced by the patient over the previous week using VAS (0 no pain, to 10, most severe pain). Part 2 is the disability subgroup and includes eight questions and measures the degree of difficulty (0 no difficulty, to 10, requires help) in the movements of the patient during the last week.

SPADI includes 13 questions, and zero point refers to maximal well-being and 130 points refers to maximal sickness. We evaluated each part of the SPADI; shoulder pain index (SPADI-SPI), shoulder disability index (SPADI-SDI) and total SPADI (SPADI-T) separately. Validity of SPADI was demonstrated in the literature. The Turkish version of the validity and reliability evaluation study for SPADI has already been implemented.
SPADI) was applied to the patients before the procedure and at the 4th week and 12th week after the procedure.
Supraspinatus tendon thickness
Time Frame: Supraspinatus tendon thickness was measured using ultrasonography before the study , four weeks after treatment , and 12 weeks later.
Shoulder ultrasonography was performed on all patients using a 5-12 MHz linear array transducer by the same physician who was experienced in musculoskeletal system ultrasonography and was unaware of the patients' treatment group. Imaging was performed with the patient in a sitting position. The patient was asked to place the hand of the side under examination with the palm on the hip of the same side. (Modified Crass & Middleton position). While the arm was in extension and internal rotation positions, the probe was placed transversely to the lower part of the acromion, and the supraspinatus tendon and biceps tendon were seen in the same section. This image was frozen and 10-15-20 mm lateral from the end of the hyperechoic image of the biceps tendon was marked and supraspinatus tendon thickness was measured from these points.
Supraspinatus tendon thickness was measured using ultrasonography before the study , four weeks after treatment , and 12 weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Öznur Uzun, MD, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 12, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2-23-3841
  • Ankara Bilkent City Hospital (Other Identifier: Ankara Bilkent City Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We can share our Study Protocol, Statistical Analysis plan and patients' informed Consent Forms.

IPD Sharing Time Frame

The IPD will become available starting 6 months after publication.

IPD Sharing Access Criteria

The doctors who are specialized in Physical Medicine and Rehabilitation will be able to access upon contact with the principal investigators via email.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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