Clinical trial NCT04779190: Physical Therapy in Shoulder Impingement Syndrome
Official title: Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline activity pain score at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
Secondary outcomes:
measure: Change from baseline rest pain score at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
measure: Change from baseline night pain score at 1-months and 3-months
timeFrame: Baseline, 1-month, 3-month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Nalan Capan
role: STUDY_DIRECTOR
References: