Supraspinatus TearNCT05335785
Efficacy of High Intensity Lazer Therapy in Partial Supraspinatus Tear
A study testing High-intensity lazer therapy and Exercises in people with Supraspinatus Tear, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Supraspinatus Tear
- What is being tested?
- High-intensity lazer therapy and Exercises
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2020to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Karabaglar, 35360
About this study
Official title: Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear
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.
Read the detailed description
90 patients aged 20-60 years who were diagnosed with partial supraspinatus tear and met the inclusion criteria of the study will be included in the study. Patients will be randomized into three groups: 30 patients in the first group who have 5 sessions of high-intensity laser, 30 patients in the second group who have 10 sessions of high-intensity laser, and 30 patients in the third group control group who have only exercises. It was planned to give 5 sessions of laser+exercise every other day to the the first group, 10 sessions of laser+exercise every other day to the second group, and only exercise program three days in a week to the control group. All groups will be evaluated with joint range of motion (ROM) (measurements including abduction, adduction, flexion, extension, internal and external rotation by goniometer according to neutral 0 position), visual analog scale (VAS), shoulder pain dissability index, quickdash, constant score at 0th month, 1st month, 3rd and 6th months.
- Conditions
- Supraspinatus Tear
- Being tested
- High-intensity lazer therapy, Exercises
- Keywords
- shoulder, supraspinatus tear, rotator cuff tear, hiltherapy, lazer therapy
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity lazer therapyDevice
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.
ExercisesOther
Exercise program including Codman, Range of motion and streightening exercises three times in a week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (visuel analog score)
evaluation of pain with scale of between 0 and 10 that means 0 no pain and 10 too much pain.
Measured: 3rd month
Secondary outcomes (1)
Constant score
The Constant score (CS) is one of the most frequently applied tools for the assessment of the shoulder joint.The Constant score is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient
Measured: 6 th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start2 Dec 2020
- Primary completion2 Dec 2022 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Supraspinatus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Korhan Barıs Bayram, Izmir Katip Celebi University
- Investigators
- Korhan Barış Bayram, assoc. prof., Study director, Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335785
- Sponsor's protocol ID
- IzmirKCU*
- Status last verified
- Apr 2022
- First submitted
- 8 Mar 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol will be shared for first 6 months after the study finish results and statisitcs will be shared.
Publications
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.
PubMed 16450690Boileau 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.
PubMed 15930531Elsodany 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.
PubMed 30188253Haslerud 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.
PubMed 25450903Aleem 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.
PubMed 23040552
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High Intensity Lazer Therapy in Patients Diagnosed With Partial Supraspinatus Tear
- ClinicalTrials.gov ID
- NCT05335785
- Acronym / sponsor ID
- IzmirKCU*
- Conditions
- Supraspinatus Tear
- Keywords
- shoulder, supraspinatus tear, rotator cuff tear, hiltherapy, lazer therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 2 Dec 2022 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
90 patients aged 20-60 years who were diagnosed with partial supraspinatus tear and met the inclusion criteria of the study will be included in the study. Patients will be randomized into three groups: 30 patients in the first group who have 5 sessions of high-intensity laser, 30 patients in the second group who have 10 sessions of high-intensity laser, and 30 patients in the third group control group who have only exercises. It was planned to give 5 sessions of laser+exercise every other day to the the first group, 10 sessions of laser+exercise every other day to the second group, and only exercise program three days in a week to the control group. All groups will be evaluated with joint range of motion (ROM) (measurements including abduction, adduction, flexion, extension, internal and external rotation by goniometer according to neutral 0 position), visual analog scale (VAS), shoulder pain dissability index, quickdash, constant score at 0th month, 1st month, 3rd and 6th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| 5 session lazer therapy | Active comparator | Device: High-intensity lazer therapy30 patients will be included to 5 session lazer therapy group. They will take totally 5 sessions of high-intensity laser every other day. |
| 10 session lazer therapy | Active comparator | Device: High-intensity lazer therapy30 patients will be included to 10 session lazer therapy group. They will take totally 10 sessions of high-intensity laser every other day. |
| control group | Other | Other: Exercises30 patients will be included to control group. They will take only exercise program three times in a week. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity lazer therapyPatients 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. | Device | 10 session lazer therapy, 5 session lazer therapy |
| ExercisesExercise program including Codman, Range of motion and streightening exercises three times in a week. | Other | control group |
Primary outcome
VAS (visuel analog score)
Time frame: 3rd month
evaluation of pain with scale of between 0 and 10 that means 0 no pain and 10 too much pain.
1 secondary outcome
Constant score
Time frame: 6 th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 16450690Meislin 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.
- Background: PubMed 15930531Boileau 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.
- Background: PubMed 30188253Elsodany 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.
- Background: PubMed 25450903Haslerud 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.
- Background: PubMed 23040552Aleem 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.
- Individual participant dataSharing planned: Yes. study protocol will be shared for first 6 months after the study finish results and statisitcs will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Korhan Barış Bayram, assoc. prof. study director
Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity lazer therapy and Exercises in people with Supraspinatus Tear, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (visuel analog score) (time frame: 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335785, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.