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

Subacromial Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169880
• Other study ID #: 1495-GOA 2015/23-30
• Status: Completed
• Phase: N/A
• Start date: May 5, 2014
• Est. completion date: May 27, 2016

Study information

• Verified date: November 2019
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 27, 2016
• Est. primary completion date: January 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

Device:
• 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.

Combination Product:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dokuz Eylul University	Scientific Research Projects

References & Publications (11)

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. — View Citation

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.

Çelik 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. — View Citation

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

Haik MN, Camargo PR, Zanca GG, Alburquerque-Sendín 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Riddle DL, Rothstein JM, Lamb RL. Goniometric reliability in a clinical setting. Shoulder measurements. Phys Ther. 1987 May;67(5):668-73. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Primary	Shoulder Range of Motion Evaluation	Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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).	4 weeks