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

Ankara City Hospital

Status: Completed

Conditions: Shoulder Pain; Supraspinatus Tear

Treatments: Device: High intensity laser therapy; Other: Therapeutic Exercise; Device: Ultrasound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06637410

E2-23-3841

Ankara Bilkent City Hospital (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 41 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups

HILT (HILT Group)

Experimental group

Description:

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.

Treatment:

Other: Therapeutic Exercise

Device: High intensity laser therapy

Ultrasound therapy (US Group)

Active Comparator group

Description:

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%.

Treatment:

Device: Ultrasound therapy

Other: Therapeutic Exercise