Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline activity pain score at 1-months and 3-months
Study Overview
Brief Summary
The aim of this study is to evaluate the effects of low-level laser therapy (LLLT) and therapeutic ultrasound combined with home-based exercise in comparison with home-based exercise alone in patients with subacromial impingement syndrome (SIS). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Detailed Description
SIS is an important cause of pain and disability and affects activities of daily living. Therefore, a major goal of SIS treatment is to reduce pain and improve upper extremity function. In this prospective, randomized controlled, single-blind, interventional trial, a total of 60 patients with SIS who met the eligibility criteria are going to enrolled in the study. Eligible participants are going to randomly assign to one of the three groups by an independent blinded researcher, using a computer-generated random numbers and allocation ratio of 1:1:1: the LLLT group (LG, n = 20), the ultrasound therapy group (UG, n = 20), and the control group (CG, n = 20). Participants are going to evaluate before training, and at the 1-month follow-up and 3-month follow-up using the visual analog scale (VAS) scores for pain during activity, at rest, and at night, and the Shoulder Pain and Disability Index (SPADI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of subacromial impingement syndrome based on physical examinations
- •Persistent pain in one shoulder for at least 2 months
- •No passive shoulder range of motion limitations
- •Failure of improvement in pain after analgesic medications
Exclusion Criteria
- •History of malignancy and systemic rheumatic diseases
- •Evidence of systemic or local infection
- •Presence of major trauma at the affected shoulder
- •History of shoulder surgery
- •Rotator cuff lesions in the form of either calcific tendinosis or full-thickness tear as confirmed on MRI scanning
Arms & Interventions
Low-level laser therapy
In the low-level laser therapy group, each patient are going to receive low-level laser therapy and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions.
Intervention: Low-level laser therapy (Device)
Low-level laser therapy
In the low-level laser therapy group, each patient are going to receive low-level laser therapy and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions.
Intervention: Home-based exercise (Other)
Therapeutic ultrasound
In the therapeutic ultrasound group, each patient are going to receive therapeutic ultrasound and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions.
Intervention: Therapeutic ultrasound (Device)
Therapeutic ultrasound
In the therapeutic ultrasound group, each patient are going to receive therapeutic ultrasound and cold-pack therapy and perform a home-based exercise program 5 times a week, once a day for 15 sessions.
Intervention: Home-based exercise (Other)
Control
Participants are going to perform a home-based exercise program and receive cold-pack therapy 5 times a week, once a day for 15 sessions.
Intervention: Home-based exercise (Other)
Outcomes
Primary Outcomes
Change from baseline activity pain score at 1-months and 3-months
Time Frame: Baseline, 1-month, 3-month
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Secondary Outcomes
- Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months(Baseline, 1-month, 3-month)
- Change from baseline rest pain score at 1-months and 3-months(Baseline, 1-month, 3-month)
- Change from baseline night pain score at 1-months and 3-months(Baseline, 1-month, 3-month)
Investigators
Ekin Ilke Sen
Assistant Professor
Istanbul University