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

NCT04169880 | Completed

• 1 other identifier: 1495-GOA 2015/23-30
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Subacromial Impingement Syndrome

Keywords

Subacromial impingement syndrome; High Intensity Laser Therapy; Laser Therapy; Shoulder Pain

Outcome Measures

Primary Outcomes (6)

• 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

• Shoulder Range of Motion Evaluation

  Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).

  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.

  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.

  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.

  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).

  4 weeks

Study Arms (2)

HILT Group

EXPERIMENTAL

HILT Group (n=15)

Device: HILT

HILT & EXERCISE Group

EXPERIMENTAL

HILT\&Exercise Group (n=15)

Combination Product: HILT & EXERCISE

Interventions

HILT 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.

Also known as: BTL 6000 High Intensity Laser (London, UK)

HILT Group

HILT & EXERCISE 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.

HILT & EXERCISE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Scientific Research Projects: collaborator

Related Publications (11)

• 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.

  PMID: 27220527 BACKGROUND

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

  PMID: 12858463 BACKGROUND

• 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.

  PMID: 3575423 BACKGROUND

• 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.

  PMID: 16253043 BACKGROUND

• 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.

  PMID: 20108852 BACKGROUND

• 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.

  PMID: 21704796 BACKGROUND

• 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.

  PMID: 22515172 BACKGROUND

• 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.

  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.

  PMID: 26854052 BACKGROUND

• 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.

  PMID: 28630217 BACKGROUND

• 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.

  PMID: 22607807 BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sevgi Sevi Yeşilyaprak, Assoc. Prof. PT.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Our study is a parallel group randomised comparison trial comparing two interventions with a 1:1 ratio.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: May 5, 2014
• Primary Completion: January 6, 2016
• Study Completion: May 27, 2016
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share