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Clinical Trials/NCT05469672
NCT05469672CompletedNot Applicable

The Effect of Low-level Laser Versus High-intensity Laser Therapy in the Management of Adhesive Capsulitis: a Randomized Clinical Trial

Necmettin Erbakan University1 site in 1 country40 target enrollmentStarted: December 25, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
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

Study Overview

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

Detailed Description

This study will be designed as a randomized, prospective, single-blind clinical trial with a 3-week follow-up. A total of 50 patients who applied to our hospital with the complaint of shoulder pain will be evaluated for inclusion in the study. Patients will be randomized into two groups as high-intensity laser (HILT) + stretching exercise group and low-level laser (LLLT) + stretching exercise group.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

low-level laser therapy

Active Comparator

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

Intervention: Low-level laser therapy (Other)

low-level laser therapy

Active Comparator

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

Intervention: High-intensity laser therapy (Other)

high-intensity laser therapy

Active Comparator

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

Intervention: Low-level laser therapy (Other)

high-intensity laser therapy

Active Comparator

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

Intervention: High-intensity laser therapy (Other)

Outcomes

Primary Outcomes

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

Time Frame: Baseline-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.

Secondary Outcomes

  • Measuring the range of motion at shoulder joint(Baseline and week 3)
  • Shoulder Pain and Disability Index(Baseline and week 3)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Banu Ordahan

Clinical Professor

Necmettin Erbakan University

Study Sites (1)

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