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

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HILT
HILT & EXERCISE
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring Subacromial impingement syndrome, High Intensity Laser Therapy, Laser Therapy, Shoulder Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    HILT Group

    HILT & EXERCISE Group

    Arm Description

    HILT Group (n=15)

    HILT&Exercise Group (n=15)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 18, 2019
    Last Updated
    November 21, 2019
    Sponsor
    Dokuz Eylul University
    Collaborators
    Scientific Research Projects
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04169880
    Brief Title
    Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome
    Official Title
    Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 5, 2014 (Actual)
    Primary Completion Date
    January 6, 2016 (Actual)
    Study Completion Date
    May 27, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dokuz Eylul University
    Collaborators
    Scientific Research Projects

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Subacromial Impingement Syndrome
    Keywords
    Subacromial impingement syndrome, High Intensity Laser Therapy, Laser Therapy, Shoulder Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Our study is a parallel group randomised comparison trial comparing two interventions with a 1:1 ratio.
    Masking
    Participant
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HILT Group
    Arm Type
    Experimental
    Arm Description
    HILT Group (n=15)
    Arm Title
    HILT & EXERCISE Group
    Arm Type
    Experimental
    Arm Description
    HILT&Exercise Group (n=15)
    Intervention Type
    Device
    Intervention Name(s)
    HILT
    Other Intervention Name(s)
    BTL 6000 High Intensity Laser (London, UK)
    Intervention Description
    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
    Combination Product
    Intervention Name(s)
    HILT & EXERCISE
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain Evaluation:Visual Analogue Scale (VAS)
    Description
    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.
    Time Frame
    4 weeks
    Title
    Shoulder Range of Motion Evaluation
    Description
    Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).
    Time Frame
    4 weeks
    Title
    Pain-free Range of Motion Evaluation
    Description
    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.
    Time Frame
    4 weeks
    Title
    Muscle Strength Evaluation
    Description
    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.
    Time Frame
    4 weeks
    Title
    Shoulder Joint Position Sense (JPS) Evaluation
    Description
    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.
    Time Frame
    4 weeks
    Title
    Shoulder Function and Disability Evaluation
    Description
    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).
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sevgi Sevi Yeşilyaprak, Assoc. Prof. PT.
    Organizational Affiliation
    Dokuz Eylul University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27220527
    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.
    Results Reference
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    PubMed Identifier
    12858463
    Citation
    Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.
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    PubMed Identifier
    3575423
    Citation
    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.
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    PubMed Identifier
    16253043
    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.
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    PubMed Identifier
    20108852
    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. doi: 10.1123/jsr.18.4.502.
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    21704796
    Citation
    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.
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    Citation
    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.
    Results Reference
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    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.
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    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.
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    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.
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    Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome

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