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

NCT ID: NCT04169880

Last Updated: 2019-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-05

Study Completion Date

2016-05-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Subacromial Impingement Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Our study is a parallel group randomised comparison trial comparing two interventions with a 1:1 ratio.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The author who did not perform evaluation or treatment of the patients assessed participants for eligibility and assigned them to one of the two groups; HILT (n=15) and HILT\&Exercise (n=15) (Figure 1) by a computerized random number generator (Random.org; Randomness and Integrity Services Ltd, Dublin, Ireland; httpp://www.random.org). Participants did not know there were two groups and which group they were in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HILT Group

HILT Group (n=15)

Group Type EXPERIMENTAL

HILT

Intervention Type DEVICE

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 & EXERCISE Group

HILT\&Exercise Group (n=15)

Group Type EXPERIMENTAL

HILT & EXERCISE

Intervention Type COMBINATION_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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HILT

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.

Intervention Type DEVICE

HILT & EXERCISE

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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BTL 6000 High Intensity Laser (London, UK)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Scientific Research Projects

UNKNOWN

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Seda Paskal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sevgi Sevi Yeşilyaprak, Assoc. Prof. PT.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27220527 (View on PubMed)

Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.

Reference Type BACKGROUND
PMID: 12858463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3575423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16253043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20108852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21704796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22515172 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 26854052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28630217 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22607807 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1495-GOA 2015/23-30

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.