Effectiveness of High Intensity Laser Treatment In Partial Supraspinatus Tendon Tears

NCT06637410 | Completed

• 2 other identifiers: E2-23-3841Ankara Bilkent City Hospital
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain; Supraspinatus Tear

Keywords

HILT; rotator cuff; shoulder pain; supraspinatus; ultrasound

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) for pain

  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 Outcomes (2)

• Shoulder Pain and Disability Index (SPADI)

  SPADI) was applied to the patients before the procedure and at the 4th week and 12th week after the procedure.

• Supraspinatus tendon thickness

  Supraspinatus tendon thickness was measured using ultrasonography before the study , four weeks after treatment , and 12 weeks later.

Study Arms (2)

HILT (HILT Group)

EXPERIMENTAL

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; Other: Therapeutic Exercise

Ultrasound therapy (US Group)

ACTIVE COMPARATOR

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; Other: Therapeutic Exercise

Interventions

High intensity laser therapy DEVICE

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.

HILT (HILT Group)

Ultrasound therapy DEVICE

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%.

Ultrasound therapy (US Group)

Therapeutic Exercise OTHER

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.

HILT (HILT Group); Ultrasound therapy (US Group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (10)

• Alayat MSM, Atya AM, Ali MME, Shousha TM. Correction to: Long-term effect of high-intensity laser therapy in the treatment of patients with chronic low back pain: a randomized blinded placebo-controlled trial. Lasers Med Sci. 2020 Feb;35(1):297. doi: 10.1007/s10103-019-02926-x.

  PMID: 31788745 RESULT

• Alayat MS, Mohamed AA, Helal OF, Khaled OA. Efficacy of high-intensity laser therapy in the treatment of chronic neck pain: a randomized double-blind placebo-control trial. Lasers Med Sci. 2016 May;31(4):687-94. doi: 10.1007/s10103-016-1910-2. Epub 2016 Feb 25.

  PMID: 26914684 RESULT

• Alayat MS, Elsodany AM, Miyajan AF, Alzhrani AA, Alzhrani HMS, Maqliyah AM. Changes in local skin temperature after the application of a pulsed Nd:YAG laser to healthy subjects: a prospective crossover controlled trial. Lasers Med Sci. 2019 Oct;34(8):1681-1688. doi: 10.1007/s10103-019-02769-6. Epub 2019 Mar 22.

  PMID: 30903525 RESULT

• Dundar U, Turkmen U, Toktas H, Solak O, Ulasli AM. Effect of high-intensity laser therapy in the management of myofascial pain syndrome of the trapezius: a double-blind, placebo-controlled study. Lasers Med Sci. 2015 Jan;30(1):325-32. doi: 10.1007/s10103-014-1671-8. Epub 2014 Oct 2.

  PMID: 25274197 RESULT

• Santamato A, Solfrizzi V, Panza F, Tondi G, Frisardi V, Leggin BG, Ranieri M, Fiore P. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of people with subacromial impingement syndrome: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):643-52. doi: 10.2522/ptj.20080139. Epub 2009 May 29.

  PMID: 19482902 RESULT

• Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.

  PMID: 2182260 RESULT

• Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.

  PMID: 16282408 RESULT

• Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022 Dec 8;23(1):1073. doi: 10.1186/s12891-022-05973-8.

  PMID: 36476476 RESULT

• Castro BKC, Correa FG, Maia LB, Oliveira VC. Effectiveness of conservative therapy in tendinopathy-related shoulder pain: A systematic review of randomized controlled trials. Phys Ther Sport. 2021 May;49:15-20. doi: 10.1016/j.ptsp.2021.01.010. Epub 2021 Jan 28.

  PMID: 33550201 RESULT

• Uzun O, Bilir EE, Arslan HB, Senturk B, Tezen O. Effectiveness of high intensity laser treatment in partial supraspinatus tendon tears: a randomised controlled trial. Lasers Med Sci. 2025 Jan 23;40(1):36. doi: 10.1007/s10103-025-04307-z.

  PMID: 39849169 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

Ultrasonic Therapy; Exercise Therapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Physical Therapy Modalities

Study Officials

• Öznur Uzun, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, specialist of physical therapy and rehabilitation, deputy chief physician

Model Details: Group 1 (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. Group 2 (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. 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 under the supervision of an experienced physiotherapist while taking their treatments.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will become available starting 6 months after publication.
• 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.

Locations

TU (1)