NCT07586800

Brief Summary

This randomized controlled trial aimed to compare the short-term effectiveness of high-intensity laser therapy (HILT) and a multimodal physiotherapy program in patients with subacromial impingement syndrome (SIS). Ninety-four participants were allocated to either HILT or combined physiotherapy, and both groups received an identical supervised exercise program. Primary outcome measures included shoulder pain assessed using the visual analogue scale (VAS). Secondary outcomes included shoulder function, disability, and quality of life. Outcomes were evaluated at baseline, post-treatment, and short-term follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

High-Intensity Laser TherapyHILTPhysiotherapyShoulder RehabilitationExercise TherapyRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain Intensity Assessed by Visual Analogue Scale (VAS)

    Pain intensity at rest, during movement, and at night assessed using a 10-cm visual analogue scale.

    Baseline, 3 weeks, and 7 weeks

Secondary Outcomes (2)

  • Shoulder Function Assessed by Constant-Murley Score

    Baseline, 3 weeks, and 7 weeks

  • Shoulder Disability Assessed by SPADI

    Baseline, 3 weeks, and 7 weeks

Study Arms (2)

High-Intensity Laser Therapy

EXPERIMENTAL

Participants received class IV Nd:YAG high-intensity laser therapy three times weekly for three weeks in addition to a supervised exercise program.

Device: High-Intensity Laser Therapy

Multimodal Physiotherapy

ACTIVE COMPARATOR

Participants received hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound combined with a supervised exercise program.

Other: Multimodal Physiotherapy

Interventions

Class IV Nd:YAG laser therapy (1064 nm wavelength) administered to the shoulder region for treatment of subacromial impingement syndrome.

High-Intensity Laser Therapy

Combined physiotherapy program consisting of hot pack therapy, transcutaneous electrical nerve stimulation, and therapeutic ultrasound.

Multimodal Physiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 to 65 years
  • Clinically and radiologically confirmed subacromial impingement syndrome
  • Shoulder pain lasting at least 1 month and less than 6 months
  • At least one positive impingement test (Neer, Hawkins-Kennedy, painful arc, or Jobe test)
  • MRI findings consistent with stage I-II rotator cuff changes

You may not qualify if:

  • Previous shoulder surgery or trauma
  • Inflammatory rheumatic disease
  • Recent myocardial infarction
  • Active infection
  • Previous physiotherapy or corticosteroid injection within the last 6 months
  • Pregnancy
  • Calcific tendinitis
  • Adhesive capsulitis
  • Cervical radiculopathy
  • Neurological disorders affecting the shoulder
  • Full-thickness rotator cuff tear
  • Contraindications to electrotherapy or laser therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tulay Yildirim, MD

    Inonu University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment was performed by a physician blinded to group allocation. Due to the nature of the interventions, participant and care provider blinding were not feasible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to either high-intensity laser therapy or multimodal physiotherapy, with both groups receiving an identical supervised exercise program.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Inonu University Faculty of Medicine

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 14, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share