Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 30
- Primary Endpoint
- Pain Evaluation:Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
HILT Group
HILT Group (n=15)
Intervention: HILT (Device)
HILT & EXERCISE Group
HILT&Exercise Group (n=15)
Intervention: HILT & EXERCISE (Combination Product)
Outcomes
Primary Outcomes
Pain Evaluation:Visual Analogue Scale (VAS)
Time Frame: 4 weeks
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
Time Frame: 4 weeks
Active and passive ROM will be evaluated with universal goniometer (Baseline®, Fabrication End Inc, New York, USA).
Pain-free Range of Motion Evaluation
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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 Outcomes
No secondary outcomes reported
Investigators
Seda Paskal
Principal Investigator
Dokuz Eylul University