Physical Therapy in Shoulder Impingement Syndrome

Subacromial Impingement Syndrome Clinical Trial

Official title:

Low-level Laser Therapy Versus Ultrasound Therapy Combined With Exercise in Patients With Subacromial Impingement Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779190
• Other study ID #: IstanbulU-2017-855
• Status: Completed
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: July 10, 2021

Study information

• Verified date: July 2021
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 10, 2021
• Est. primary completion date: July 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

Device:
• Low-level laser therapy
Gallium-aluminum-arsenide diode laser device
• Therapeutic ultrasound
Therapeutic pulsed ultrasound with a frequency of 1 MHz

Other:
• Home-based exercise
Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.

Locations

Country	Name	City	State
Turkey	Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline activity pain score at 1-months and 3-months	Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month
Secondary	Change from baseline rest pain score at 1-months and 3-months	Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month
Secondary	Change from baseline Shoulder Pain and Disability Index at 1-months and 3-months	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)	Baseline, 1-month, 3-month
Secondary	Change from baseline night pain score at 1-months and 3-months	Visual Analogue Scale- Night pain (0-10 point). Higher scores mean a worse outcome	Baseline, 1-month, 3-month