Physical Therapy in Shoulder Impingement Syndrome

Not Applicable

Completed

• Conditions: Subacromial Impingement Syndrome
• Interventions: Device: Therapeutic ultrasound; Device: Low-level laser therapy; Other: Home-based exercise

• Registration Number: NCT04779190
• Lead Sponsor: Istanbul University

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 Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Study Start: 2021-03-04
• Status Verified: 2021-07
• Primary Completion: 2021-07-10
• Study Completion: 2021-07-10
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic ultrasound	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.
Low-level laser therapy	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.
Control	Home-based exercise	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.
Low-level laser therapy	Home-based exercise	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.
Therapeutic ultrasound	Home-based exercise	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline activity pain score at 1-months and 3-months	Baseline, 1-month, 3-month	Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months	Baseline, 1-month, 3-month	Shoulder Pain and Disability Index (SPADI) measures shoulder pain and shoulder disability. Total score ranges from 0 to 130, where a higher score indicates a worsening status. Each item is scored with the VAS, which ranges from 0 (no pain or no difficulty) to 10 (worst pain imaginable or very difficult, help required)
Change from baseline rest pain score at 1-months and 3-months	Baseline, 1-month, 3-month	Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Change from baseline night pain score at 1-months and 3-months	Baseline, 1-month, 3-month	Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome

Trial Locations

Locations (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation; 🇹🇷 Istanbul, Turkey