An interventional study of HILT and HILT & EXERCISE in Subacromial Impingement Syndrome, sponsored by Dokuz Eylul University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-25.
Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Treatment
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.
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's enrollment of 30 is below the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
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Exclusion Criteria:
HILT Group (n=15)
Device: HILT
HILT\&Exercise Group (n=15)
Combination Product: HILT & EXERCISE
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\&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.
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.
Time frame: 4 weeks
Shoulder Range of Motion Evaluation
Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Dokuz Eylul University