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

Not Applicable

Completed

• Conditions: Subacromial Impingement Syndrome
• Interventions: Combination Product: HILT & EXERCISE; Device: HILT

• Registration Number: NCT04169880
• Lead Sponsor: Dokuz Eylul University

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 Timeline

• Study Start: 2014-05-05
• Primary Completion: 2016-01-06
• Study Completion: 2016-05-27
• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HILT & EXERCISE Group	HILT & EXERCISE	HILT\&Exercise Group (n=15)
HILT Group	HILT	HILT Group (n=15)

Primary Outcome Measures

Name	Time	Method
Pain Evaluation:Visual Analogue Scale (VAS)	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	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	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	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	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	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).