Subacromial Impingement SyndromeNCT04169880

Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome

A study testing HILT and HILT & EXERCISE in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Subacromial Impingement Syndrome
What is being tested?: HILT and HILT & EXERCISE
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 5 May 2014to 27 May 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed as SIS (≥3 positive of 5 impingement tests: Neer's sign, Hawkins and Kennedy, Empty Can, painful arc of abduction and external rotation resistance tests)
No history of shoulder injury and/or shoulder symptoms requiring treatment other than SIS for the last 1 year
Shoulder pain less than 7/10 of Visual Analogue Scale
Being able to elevate the shoulder over 140 degrees

Who cannot join

History of upper extremity fracture, shoulder surgery
Frozen shoulder
Full-thickness rotator cuff (RC) tear
Shoulder instability, systemic musculoskeletal disease
Shoulder pain with cervical spine motion,
Having any of the contraindications of HILT.

About this study

The aim of this study is to determine the effects of high intensity laser therapy (HILT) in patients with subacromial impingement syndrome (SIS). This study aims to compare the effects of HILT alone and HILT and therapeutic exercise combination on shoulder pain, ROM, joint position sense (JPS), muscle strength and function.The investigators hypothesized that shoulder pain, ROM, JPS, muscle strength and functionality would improve with both treatments but that HILT combined with exercise would result in better outcomes than HILT alone.

Read the detailed description

30 patients with SIS will be randomized into two groups. Pain intensity will be assessed with visual analogue scale (VAS), pain-free and normal range of motion (ROM) with goniometer, joint position sense (JPS) with inclinometer, muscle strenght with hand-held dynamometer, and shoulder functionality with Constant Murley Score (CMS) and Shoulder Pain and Disability Index (SPADI) in a pretest-posttest design. HILT Group (n=15) will receive only HILT for 10 sessions, 3 days a week on alternate days. HILT\& Exercise Group (n=15) will receive exercise treatment in addition to HILT for the same duration of time.

Conditions: Subacromial Impingement Syndrome
Being tested: HILT, HILT & EXERCISE
Keywords: Subacromial impingement syndrome, High Intensity Laser Therapy, Laser Therapy, Shoulder Pain
Medical subject headings: Shoulder Impingement Syndrome, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HILTDevice
Also called BTL 6000 High Intensity Laser (London, UK)
HILT will be performed with BTL 6000 High Intensity Laser (London, UK) which is a therapeutic non-invasive neodymium: yttrium aluminum garnet laser that has a pulsating waveform and 1064 nm wavelength, 12 Watt maximum power and has the ability to penetrate 12 cm.
HILT & EXERCISECombination product
HILT\&Exercise group will receive exercise therapy right after they receive HILT. Both groups will receive treatment for 3 days a week, on alternate days and totally 10 sessions. Patients will be asked not to use analgesic medication throughout the treatment period.

Study groups in NCT04169880
Study group	Role	What they receive
HILT Group	Experimental	HILT Group (n=15) Receives: Device: HILT
HILT & EXERCISE Group	Experimental	HILT\&Exercise Group (n=15) Receives: Combination Product: HILT & EXERCISE

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Evaluation:Visual Analogue Scale (VAS)
Rest and activity pain of the shoulder will be measured on a 10-cm VAS ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean worse outcome.
Measured: 4 weeks
Shoulder Range of Motion Evaluation
Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).
Measured: 4 weeks
Pain-free Range of Motion Evaluation
Pain-free ROM will be assessed by measuring pain-free ROM for active shoulder elevation in scapular plane with universal goniometer. While sitting on a chair with back support, patients performed elevation with their thumbs pointing up. One degree below the angle where the patient first experienced pain was recorded.
Measured: 4 weeks
Muscle Strength Evaluation
A hand-held dynamometer (HHD) (Power track II, J Tech, New York, USA) will be used to assess muscle strength. Before the evaluations test order will be randomized for lower trapezius (LT), middle trapezius (MT), upper trapezius (UT), serratus anterior (SA), supraspinatus (SupraSp), subscapularis (SubSc), infraspinatus\&teres minor (IS\&TM) muscles.
Measured: 4 weeks
Shoulder Joint Position Sense (JPS) Evaluation
A bubble inclinometer (Baseline®, Fabrication End Inc, NewYork, USA) will be used to assess active shoulder JPS. The inclinometer will be attached to an elastic strip via a velcro-band and placed on proximal humerus for abduction and on wrist for rotations. Shoulder JPS in abduction direction will be evaluated while patient sitting on a chair without back support at the angle of 100°, 19 internal rotation (IR) and external rotation (ER); while patient lying supine, at the angles of 45° IR and 75° ER.
Measured: 4 weeks
Shoulder Function and Disability Evaluation
The Turkish version of the Shoulder Pain and Disability Index (SPADI) will be used to evaluate shoulder disability level. Items in the index are presented on a numerical rating scale (0 indicates no pain/no difficulty, 10 indicates worst pain/most difficulty). Higher score indicates greater disability.
The Turkish version of the Constant-Murley Shoulder Score (CMS) will be used to evaluate shoulder function. It is a 100-points-scale composed of pain (15 points), activities of daily living (ADL) (20 points), active ROM (40 points) and strenght (25 points) subgroups. The total score is classified as excellent (90-100), good (80-89), moderate (70-79) and weak (<70).
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 201427 May 2016

First posted20 Nov 2019
Study start5 May 2014
Primary completion6 Jan 2016
Study completion27 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Subacromial Impingement SyndromeStudies 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: Our study is a parallel group randomised comparison trial comparing two interventions with a 1:1 ratio.
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04169880
Sponsor's protocol ID: 1495-GOA 2015/23-30
Status last verified: Nov 2019
First submitted: 18 Nov 2019
Last updated: 25 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Pekyavas NO, Baltaci G. Short-term effects of high-intensity laser therapy, manual therapy, and Kinesio taping in patients with subacromial impingement syndrome. Lasers Med Sci. 2016 Aug;31(6):1133-41. doi: 10.1007/s10103-016-1963-2. Epub 2016 May 25.
PubMed 27220527
Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.
PubMed 12858463
Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. doi: 10.1093/ptj/67.5.668.
PubMed 3575423
Michener LA, Boardman ND, Pidcoe PE, Frith AM. Scapular muscle tests in subjects with shoulder pain and functional loss: reliability and construct validity. Phys Ther. 2005 Nov;85(11):1128-38.
PubMed 16253043
Turner N, Ferguson K, Mobley BW, Riemann B, Davies G. Establishing normative data on scapulothoracic musculature using handheld dynamometry. J Sport Rehabil. 2009 Nov;18(4):502-20. doi: 10.1123/jsr.18.4.502.
PubMed 20108852
Anderson VB, Wee E. Impaired joint proprioception at higher shoulder elevations in chronic rotator cuff pathology. Arch Phys Med Rehabil. 2011 Jul;92(7):1146-51. doi: 10.1016/j.apmr.2011.02.004.
PubMed 21704796
Haik MN, Camargo PR, Zanca GG, Alburquerque-Sendin F, Salvini TF, Mattiello-Rosa SM. Joint position sense is not altered during shoulder medial and lateral rotations in female assembly line workers with shoulder impingement syndrome. Physiother Theory Pract. 2013 Jan;29(1):41-50. doi: 10.3109/09593985.2012.676722. Epub 2012 Apr 20.
PubMed 22515172
Bumin G, Tuzun EH, Tonga E. The shoulder pain and disability index (SPADI): Cross-cultural adaptation, reliability and validity of the Turkish version. J Back Musculoskelet Rehabil. 2008;21(1): 57-62. doi: 10.3233/bmr-2008-21108.
Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.
PubMed 26854052
Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
PubMed 28630217
Hanratty CE, McVeigh JG, Kerr DP, Basford JR, Finch MB, Pendleton A, Sim J. The effectiveness of physiotherapy exercises in subacromial impingement syndrome: a systematic review and meta-analysis. Semin Arthritis Rheum. 2012 Dec;42(3):297-316. doi: 10.1016/j.semarthrit.2012.03.015. Epub 2012 May 18.
PubMed 22607807

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Subacromial Impingement Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome
ClinicalTrials.gov ID: NCT04169880
Acronym / sponsor ID: 1495-GOA 2015/23-30
Conditions: Subacromial Impingement Syndrome
Keywords: Subacromial impingement syndrome, High Intensity Laser Therapy, Laser Therapy, Shoulder Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Dokuz Eylul UniversityUniversity, hospital or other
Collaborators: Scientific Research Projects
Study start: 5 May 2014 (actual)
Primary completion: 6 Jan 2016 (actual)
Study completion: 27 May 2016 (actual)
First posted: 20 Nov 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Our study is a parallel group randomised comparison trial comparing two interventions with a 1:1 ratio.

Arm	Type	Receives
HILT Group	Experimental	Device: HILTHILT Group (n=15)
HILT & EXERCISE Group	Experimental	Combination Product: HILT & EXERCISEHILT\&Exercise Group (n=15)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosed as SIS (≥3 positive of 5 impingement tests: Neer's sign, Hawkins and Kennedy, Empty Can, painful arc of abduction and external rotation resistance tests)
No history of shoulder injury and/or shoulder symptoms requiring treatment other than SIS for the last 1 year
Shoulder pain less than 7/10 of Visual Analogue Scale
Being able to elevate the shoulder over 140 degrees

Key exclusion criteria (6 listed)

History of upper extremity fracture, shoulder surgery
Frozen shoulder
Full-thickness rotator cuff (RC) tear
Shoulder instability, systemic musculoskeletal disease
Shoulder pain with cervical spine motion,

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
HILTAlso: BTL 6000 High Intensity Laser (London, UK)HILT will be performed with BTL 6000 High Intensity Laser (London, UK) which is a therapeutic non-invasive neodymium: yttrium aluminum garnet laser that has a pulsating waveform and 1064 nm wavelength, 12 Watt maximum power and has the ability to penetrate 12 cm.	Device	HILT Group
HILT & EXERCISEHILT\&Exercise group will receive exercise therapy right after they receive HILT. Both groups will receive treatment for 3 days a week, on alternate days and totally 10 sessions. Patients will be asked not to use analgesic medication throughout the treatment period.	Combination product	HILT & EXERCISE Group

Primary outcome

Pain Evaluation:Visual Analogue Scale (VAS)
Time frame: 4 weeks
Rest and activity pain of the shoulder will be measured on a 10-cm VAS ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean worse outcome.
Shoulder Range of Motion Evaluation
Time frame: 4 weeks
Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).
Pain-free Range of Motion Evaluation
Time frame: 4 weeks
Pain-free ROM will be assessed by measuring pain-free ROM for active shoulder elevation in scapular plane with universal goniometer. While sitting on a chair with back support, patients performed elevation with their thumbs pointing up. One degree below the angle where the patient first experienced pain was recorded.
Muscle Strength Evaluation
Time frame: 4 weeks
A hand-held dynamometer (HHD) (Power track II, J Tech, New York, USA) will be used to assess muscle strength. Before the evaluations test order will be randomized for lower trapezius (LT), middle trapezius (MT), upper trapezius (UT), serratus anterior (SA), supraspinatus (SupraSp), subscapularis (SubSc), infraspinatus\&teres minor (IS\&TM) muscles.
Shoulder Joint Position Sense (JPS) Evaluation
Time frame: 4 weeks
A bubble inclinometer (Baseline®, Fabrication End Inc, NewYork, USA) will be used to assess active shoulder JPS. The inclinometer will be attached to an elastic strip via a velcro-band and placed on proximal humerus for abduction and on wrist for rotations. Shoulder JPS in abduction direction will be evaluated while patient sitting on a chair without back support at the angle of 100°, 19 internal rotation (IR) and external rotation (ER); while patient lying supine, at the angles of 45° IR and 75° ER.
Shoulder Function and Disability Evaluation
Time frame: 4 weeks
The Turkish version of the Shoulder Pain and Disability Index (SPADI) will be used to evaluate shoulder disability level. Items in the index are presented on a numerical rating scale (0 indicates no pain/no difficulty, 10 indicates worst pain/most difficulty). Higher score indicates greater disability. The Turkish version of the Constant-Murley Shoulder Score (CMS) will be used to evaluate shoulder function. It is a 100-points-scale composed of pain (15 points), activities of daily living (ADL) (20 points), active ROM (40 points) and strenght (25 points) subgroups. The total score is classified as excellent (90-100), good (80-89), moderate (70-79) and weak (<70).

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 25 Nov 2019.
Background: PubMed 27220527Pekyavas NO, Baltaci G. Short-term effects of high-intensity laser therapy, manual therapy, and Kinesio taping in patients with subacromial impingement syndrome. Lasers Med Sci. 2016 Aug;31(6):1133-41. doi: 10.1007/s10103-016-1963-2. Epub 2016 May 25.
Background: PubMed 12858463Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.
Background: PubMed 3575423Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. doi: 10.1093/ptj/67.5.668.
Background: PubMed 16253043Michener LA, Boardman ND, Pidcoe PE, Frith AM. Scapular muscle tests in subjects with shoulder pain and functional loss: reliability and construct validity. Phys Ther. 2005 Nov;85(11):1128-38.
Background: PubMed 20108852Turner N, Ferguson K, Mobley BW, Riemann B, Davies G. Establishing normative data on scapulothoracic musculature using handheld dynamometry. J Sport Rehabil. 2009 Nov;18(4):502-20. doi: 10.1123/jsr.18.4.502.
Background: PubMed 21704796Anderson VB, Wee E. Impaired joint proprioception at higher shoulder elevations in chronic rotator cuff pathology. Arch Phys Med Rehabil. 2011 Jul;92(7):1146-51. doi: 10.1016/j.apmr.2011.02.004.
Background: PubMed 22515172Haik MN, Camargo PR, Zanca GG, Alburquerque-Sendin F, Salvini TF, Mattiello-Rosa SM. Joint position sense is not altered during shoulder medial and lateral rotations in female assembly line workers with shoulder impingement syndrome. Physiother Theory Pract. 2013 Jan;29(1):41-50. doi: 10.3109/09593985.2012.676722. Epub 2012 Apr 20.
BackgroundBumin G, Tuzun EH, Tonga E. The shoulder pain and disability index (SPADI): Cross-cultural adaptation, reliability and validity of the Turkish version. J Back Musculoskelet Rehabil. 2008;21(1): 57-62. doi: 10.3233/bmr-2008-21108.
Background: PubMed 26854052Celik D. Turkish version of the modified Constant-Murley score and standardized test protocol: reliability and validity. Acta Orthop Traumatol Turc. 2016;50(1):69-75. doi: 10.3944/AOTT.2016.14.0354.
Background: PubMed 28630217Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
Background: PubMed 22607807Hanratty CE, McVeigh JG, Kerr DP, Basford JR, Finch MB, Pendleton A, Sim J. The effectiveness of physiotherapy exercises in subacromial impingement syndrome: a systematic review and meta-analysis. Semin Arthritis Rheum. 2012 Dec;42(3):297-316. doi: 10.1016/j.semarthrit.2012.03.015. Epub 2012 May 18.
Individual participant dataSharing planned: No

Related trials for Subacromial Impingement Syndrome

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TECAR With Shoulder Chronic Shoulder Impingement Syndrome
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Recruiting
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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.

Sevgi Sevi Yeşilyaprak, Assoc. Prof. PT. principal investigator

Dokuz Eylul University

Questions about this trial

What is this clinical trial studying?

A study testing HILT and HILT & EXERCISE in people with Subacromial Impingement Syndrome, run by Dokuz Eylul University.

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 6 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Pain Evaluation:Visual Analogue Scale (VAS) (time frame: 4 weeks). The study lists 6 primary outcomes in all. 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 NCT04169880, which also lists 11 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 25 Nov 2019.