The Effect of Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
The Effect of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2021
CompletedFirst Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 22, 2022
CompletedApril 14, 2026
April 1, 2026
11 months
July 18, 2022
April 9, 2026
Conditions
Keywords
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 COMPARATORLLLT will be performed 3 times a week for a period of 3 weeks
high-intensity laser therapy
ACTIVE COMPARATORHILT will be performed 3 times a week for a period of 3 weeks
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.
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.
Eligibility Criteria
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)
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.
PMID: 37533657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BANU ORDAHAN
Meram Medical School, Necmettin Erbakan University, Konya, Turkey
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