Shoulder PainHILTNCT06637410
Effectiveness of High Intensity Laser Treatment In Partial Supraspinatus Tendon Tears
A study testing High intensity laser therapy, Ultrasound therapy and Therapeutic Exercise in people with Shoulder Pain and Supraspinatus Tear, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Supraspinatus Tear
- What is being tested?
- High intensity laser therapy, Ultrasound therapy and Therapeutic Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara, 06800
About this study
Official title: 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?
Read more
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.
Read the 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
- Conditions
- Shoulder Pain, Supraspinatus Tear
- Being tested
- High intensity laser therapy, Ultrasound therapy, Therapeutic Exercise
- Keywords
- HILT, rotator cuff, shoulder pain, supraspinatus, ultrasound
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laser therapyDevice
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.
Ultrasound therapyDevice
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%.
Therapeutic ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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%. Receives: Device: Ultrasound therapy; Other: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: SPADI) was applied to the patients before the procedure and at the 4th week and 12th week after the procedure.
Supraspinatus tendon thickness
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.
Measured: Supraspinatus tendon thickness was measured using ultrasonography before the study , four weeks after treatment , and 12 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oznur Uzun, Ankara City Hospital Bilkent
- Investigators
- Öznur Uzun, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637410
- Sponsor's protocol ID
- E2-23-3841
- Other IDs
- Ankara Bilkent City Hospital
- Acronym
- HILT
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share our Study Protocol, Statistical Analysis plan and patients' informed Consent Forms.
Publications
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.
PubMed 31788745Alayat 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.
PubMed 26914684Alayat 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.
PubMed 30903525Dundar 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.
PubMed 25274197Santamato 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.
PubMed 19482902Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.
PubMed 2182260Mitchell 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.
PubMed 16282408Lucas 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.
PubMed 36476476Castro 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.
PubMed 33550201Uzun 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.
PubMed 39849169
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of High Intensity Laser Treatment in Partial Supraspinatus Tendon Tears: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06637410
- Acronym / sponsor ID
- HILT / E2-23-3841
- Conditions
- Shoulder Pain, Supraspinatus Tear
- Keywords
- HILT, rotator cuff, shoulder pain, supraspinatus, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Oct 2024 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| HILT (HILT Group) | Experimental | Device: High intensity laser therapy, Other: Therapeutic ExerciseHILT 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. |
| Ultrasound therapy (US Group) | Active comparator | Device: Ultrasound therapy, Other: Therapeutic ExerciseUltrasound 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%. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- inflammatory rheumatic disease,
- cervical radiculopathy
- pregnancy,
- thyroid disease,
- history of cardiac pacemaker placement,
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 laser therapyHILT 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. | Device | HILT (HILT Group) |
| Ultrasound therapyUS 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%. | Device | Ultrasound therapy (US Group) |
| Therapeutic ExerciseROM 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. | Other | HILT (HILT Group), Ultrasound therapy (US Group) |
Primary outcome
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).
2 secondary outcomes
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.
Supraspinatus tendon thickness
Time frame: Supraspinatus tendon thickness was measured using ultrasonography before the study , four weeks after treatment , and 12 weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Results publication: PubMed 31788745Alayat 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.
- Results publication: PubMed 26914684Alayat 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.
- Results publication: PubMed 30903525Alayat 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.
- Results publication: PubMed 25274197Dundar 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.
- Results publication: PubMed 19482902Santamato 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.
- Results publication: PubMed 2182260Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.
- Results publication: PubMed 16282408Mitchell 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.
- Results publication: PubMed 36476476Lucas 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.
- Results publication: PubMed 33550201Castro 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.
- Derived from this study: PubMed 39849169Uzun 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.
- Individual participant dataSharing planned: Yes. We can share our Study Protocol, Statistical Analysis plan and patients' informed Consent Forms.
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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.
Öznur Uzun, MD principal investigator
Ankara City Hospital Bilkent
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 laser therapy, Ultrasound therapy and Therapeutic Exercise in people with Shoulder Pain and Supraspinatus Tear, run by Ankara City Hospital Bilkent 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 16 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). 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 NCT06637410, which also lists 10 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 16 Oct 2024.