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Completed

NCT Number: NCT04169880

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: BTL 6000 High Intensity Laser (London, UK)

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.

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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).

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Collaborators

  • Scientific Research Projects

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2019
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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