NCT05469672

Brief Summary

In this study, it was aimed to compare the effects of low-level laser therapy (LLLT) and high-intensity laser therapy (HILT) on shoulder joint range of motion, level of pain and functional status in patients with adhesive capsulitis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

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

Study Start

First participant enrolled

December 25, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

July 18, 2022

Last Update Submit

April 9, 2026

Conditions

Keywords

Adhesive capsulitis PainHigh-intensity laser therapyLow-level laser therapyPain

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. Change from baseline in pain on the VAS at week 3

    This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.

    Baseline-Week 3

Secondary Outcomes (2)

  • Shoulder Pain and Disability Index

    Baseline and week 3

  • Measuring the range of motion at shoulder joint

    Baseline and week 3

Study Arms (2)

low-level laser therapy

ACTIVE COMPARATOR

LLLT will be performed 3 times a week for a period of 3 weeks

Other: Low-level laser therapyOther: High-intensity laser therapy

high-intensity laser therapy

ACTIVE COMPARATOR

HILT will be performed 3 times a week for a period of 3 weeks

Other: Low-level laser therapyOther: High-intensity laser therapy

Interventions

For LLLT, laser treatment will be applied using gallium-aluminum-arsenide (GaAIAs, infrared laser) diode laser (Chattanooga, Mexico, USA) at a wavelength of 904 nm, output power of 240 Mw and a frequency of 5000 Hz. The spot area is about 0.5 cm2. A total of 9 points will irradiated along the glenohumeral joint, with a power density of 3 j/cm2 at each point. The application time was 50 seconds to each point. The total dose per shoulder was 27 J per treatment. Three sessions of LILT therapy per week will administered over a three-week period.

high-intensity laser therapylow-level laser therapy

HILT: A hot laser derived from a Nd: YAG laser has 12 W (watt) and 1064 nm characteristics. The device will administered to the shoulder area in two steps in the HILT group: phase I and phase II. The application will made utilizing continuous circular movements in both phases I and II. The first three sessions consisted of a 75-second intermittent phase analgesic effect at 8 W and 10 J/cm2 for a total energy of 100 J. The following six sessions consisted of a continuous 30-second bio stimulating effect with a dosage of 12 W 120 J/cm2. Over the course of three weeks, nine treatment sessions of HILT will be given.

high-intensity laser therapylow-level laser therapy

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients aged between 25-65 years
  • patients clinically diagnosed with adhesive capsulitis, characterized by limitation of passive external rotation of the affected shoulder to less than 50% of the contralateral shoulder and normal radiographic finding of the affected shoulder
  • patients with severe pain and shoulder limitation for at least 3 months
  • patients who are literate and able to understand verbal instructions in our language.

You may not qualify if:

  • Calcific tendinopathy, glenohumeral osteoarthritis, fracture, shoulder surgery, shoulder trauma, history of malignancy and infection, history of inflammatory rheumatic diseases
  • History of bilateral simultaneous adhesive capsulitis
  • Recent history of lung, breast, or bypass surgery/radiotherapy
  • History of corticosteroid injection to the same shoulder in the last 1 year
  • History of cervical radiculopathy/brachial plexus lesion
  • Neuromuscular disease history
  • History of physical therapy program for the same shoulder in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banu Ordahan

Konya, Turkey (Türkiye)

Location

Related Publications (1)

  • Ordahan B, Yigit F, Mulkoglu C. Efficacy of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: A Randomized Clinical Trial. Saudi J Med Med Sci. 2023 Jul-Sep;11(3):201-207. doi: 10.4103/sjmms.sjmms_626_22. Epub 2023 Jul 15.

MeSH Terms

Conditions

Somatoform DisordersPain

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • BANU ORDAHAN

    Meram Medical School, Necmettin Erbakan University, Konya, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 22, 2022

Study Start

December 25, 2020

Primary Completion

November 25, 2021

Study Completion

November 27, 2021

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations