NCT04779190

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

February 26, 2021

Last Update Submit

July 14, 2021

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change from baseline rest pain score at 1-months and 3-months

    Baseline, 1-month, 3-month

  • Change from baseline Shoulder Pain and Disability Index 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

Study Arms (3)

Low-level laser therapy

EXPERIMENTAL

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.

Device: Low-level laser therapyOther: Home-based exercise

Therapeutic ultrasound

EXPERIMENTAL

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.

Device: Therapeutic ultrasoundOther: Home-based exercise

Control

ACTIVE COMPARATOR

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.

Other: Home-based exercise

Interventions

Low-level laser therapyDEVICE

Gallium-aluminum-arsenide diode laser device

Low-level laser therapy
Therapeutic ultrasoundDEVICE

Therapeutic pulsed ultrasound with a frequency of 1 MHz

Therapeutic ultrasound
Home-based exerciseOTHER

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

ControlLow-level laser therapyTherapeutic ultrasound

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Low-Level Light TherapyUltrasonic Therapy

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyDiathermyHyperthermia, Induced

Study Officials

  • Nalan Capan

    Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 3, 2021

Study Start

March 4, 2021

Primary Completion

July 10, 2021

Study Completion

July 10, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Locations

TU(1)