Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear

NCT05335785 | Unknown

• 1 other identifier: IzmirKCU*
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Rotatorcuff lesions constitute 10% of the causes of shoulder pain. Supraspinatus tear is one of the common rotatorcuff lesions. It affects the quality of life negatively and causes loss of range of motion and muscle strength. It can be seen due to traumatic or degenerative causes. Its incidence increases with advanced age. While the incidence was reported as 4% in the population aged 40-60 years, this rate was reported to be 17-50% in the group over the age of 60 and 80% in the group over the age of 80. Radiologically, classification is made as partial or full-thickness tears. Rotatorcuff tears can be treated conservatively or surgically. Although the risk of post-surgical rupture is reduced with new methods, the lack of desired tendon healing has led to the search for alternative applications such as biological augmentation and high-intensity laser. The aim of this study is to reveal the effectiveness of high-intensity laser therapy in patients with partial supraspinatus tear.

Conditions

Supraspinatus Tear

Keywords

shoulder; supraspinatus tear; rotator cuff tear; hiltherapy; lazer therapy

Outcome Measures

Primary Outcomes (1)

• VAS (visuel analog score)

  evaluation of pain with scale of between 0 and 10 that means 0 no pain and 10 too much pain.

  3rd month

Secondary Outcomes (1)

• Constant score

  6 th month

Study Arms (3)

5 session lazer therapy

ACTIVE COMPARATOR

30 patients will be included to 5 session lazer therapy group. They will take totally 5 sessions of high-intensity laser every other day.

Device: High-intensity lazer therapy

10 session lazer therapy

ACTIVE COMPARATOR

30 patients will be included to 10 session lazer therapy group. They will take totally 10 sessions of high-intensity laser every other day.

Device: High-intensity lazer therapy

control group

OTHER

30 patients will be included to control group. They will take only exercise program three times in a week.

Other: Exercises

Interventions

High-intensity lazer therapy DEVICE

Patients in the laser group will be given hiltherapy (high-intensity laser) with the HIRO 3 device every other day. One session of laser therapy application consists of 3 phases: the beginning, the middle and the ending phase. The initial phases are fast scanning and the ending phase is slow scanning. A total of 2000 J will be applied to the rotatorcuff muscles, the upper part of the trapezius muscle, the deltoid muscle and the pectoralis major muscle, 1000 J in the rapid scan phase and 1000 J in the finishing phase. In the middle phase, 50 J will be applied for the trigger point (hard intramuscular points that cause referred pain) in each muscle and a maximum of 500 J in total. The total dose prescribed for patients in one session will be 2500 J. Each phase will be 15 minutes on average and the session will last for 45 minutes in total. The laser probe will be applied with 90 degrees. During the application, the practitioner and the patient will have protective glasses.

10 session lazer therapy; 5 session lazer therapy

Exercises OTHER

Exercise program including Codman, Range of motion and streightening exercises three times in a week.

control group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 20-65 years
• Patients with VAS\>4 pain in the shoulder for at least 3 months
• Patients with at least 25% loss in the range of motion of the joint compared to the contralateral side, especially in abduction and external rotation, or on physical examination or positivity of at least one of the impingement tests including jobb, lift off, ERLS , speed, yergeson, O Brien's test, dropparm tests or popeye signs.
• Diagnose of partial supraspinatus with ultrasound or MR

You may not qualify if:

• Patients with incomplete skin integrity, hyperemia, signs of infection or tattoos
• Patients with suspected full-thickness tear
• History of rheumatic disease (rheumatoidarthritis, osteoarthritis, PMR)
• Patients with accompanying shoulder pathology such as calcifictendinitis
• History of malignancy
• Surgery, manipulation, mobilization, arthroscopy performed on the affected shoulder
• Steroid, local anesthetic, hyaluronic acid injection, cnesiotaping or neural therapy in the affected shoulder in the last 3 months
• Reflex sympathetic dystrophy, neurodeficit in the affected extremity
• Diabetes patients or any Patients who cannot feel the burning pain due to a peripheral neuropathy or sensory defect
• Patients with epilepsy

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Karabaglar, 35360, Turkey (Türkiye)

Location

Related Publications (5)

• Meislin RJ, Sperling JW, Stitik TP. Persistent shoulder pain: epidemiology, pathophysiology, and diagnosis. Am J Orthop (Belle Mead NJ). 2005 Dec;34(12 Suppl):5-9.

  PMID: 16450690 BACKGROUND

• Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.

  PMID: 15930531 BACKGROUND

• Elsodany AM, Alayat MSM, Ali MME, Khaprani HM. Long-Term Effect of Pulsed Nd:YAG Laser in the Treatment of Patients with Rotator Cuff Tendinopathy: A Randomized Controlled Trial. Photomed Laser Surg. 2018 Sep;36(9):506-513. doi: 10.1089/pho.2018.4476.

  PMID: 30188253 BACKGROUND

• Haslerud S, Magnussen LH, Joensen J, Lopes-Martins RA, Bjordal JM. The efficacy of low-level laser therapy for shoulder tendinopathy: a systematic review and meta-analysis of randomized controlled trials. Physiother Res Int. 2015 Jun;20(2):108-25. doi: 10.1002/pri.1606. Epub 2014 Dec 2.

  PMID: 25450903 BACKGROUND

• Aleem AW, Brophy RH. Outcomes of rotator cuff surgery: what does the evidence tell us? Clin Sports Med. 2012 Oct;31(4):665-74. doi: 10.1016/j.csm.2012.07.004.

  PMID: 23040552 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Korhan Barış Bayram, assoc. prof.

  Katip Celebi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor doctor

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 19, 2022
• Study Start: December 2, 2020
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: when the study start and data will be avaliable for 6 months
• Access Criteria: study protocol will be shared for first 6 months after the study finish results and statisitcs will be shared.

Locations

TU (1)