Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder

Adhesive capsulitis, is a common problem characterized by the insidious onset of glenohumeral pain and limitation of shoulder motion in all planes. Clinically, frozen shoulder could be divided into freezing, frozen and thawing stage. The treatments of frozen shoulder are mainly conservative, including non-steroidal anti-inflammatory medications and physiotherapy. Due to debilitating pain at a certain stage and protracted clinical course, intra-articular corticosteroid injection in the early stages of idiopathic adhesive capsulitis has long been used to treat adhesive capsulitis with satisfactory result. However, intra-articular steroid injection still raise some controversy and is still considered too invasive for some patients.

Low-level laser therapy (LLLT) is a safe and non-invasive alternative. LLLT can employ photo-biomodulation effects to help normalize cellular functions and is considered to have partial effect in many shoulder soft tissue disorders. Possible mechanisms include increasing adenosine triphosphate production, fibroblast activity and collagen synthesis. One prospective cohort study has shown that LLLT can be effective in the management of the early phase (less than 6 weeks of disease onset) of adhesive capsulitis of the shoulder in elderly who failed to respond to conventional physical therapy and nonsteroidal anti-inflammatory medications and improvement was found maintained up to 2 years.

To this date, no randomized controlled study has been made to establish the possible role of LLLT as an adjuvant therapy on adhesive capsulitis. Also, no study has researched the effect of LLLT on patient with later stage/chronic phase of adhesive capsulitis. The objective of this paper is to report the clinical result of a study on the efficacy of LLLT as an add-on therapy in the management of adhesive capsulitis.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Device: Low-level laser therapy (LLLT); Other: Conventional physical therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chueh-Hung Wu, MD, PhD; Phone Number: 66473 +886-2312-3456; Email: nojred@gmail.com
• Study Contact Backup: Name: En Yang, MD; Phone Number: 52370 +886-2312-3456; Email: youngforever0826@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chueh-Hung Wu, MD, PhD; Phone Number: 66473 +886-2312-3456; Email: nojred@gmail.com
    • Principal Investigator: En Yang, MD
    • Principal Investigator: Ying-Chun Chen, MD
    • Principal Investigator: Hsing-Yu Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 40 to 85 years old
• Diagnosed with adhesive capsulitis clinically. Painful restriction of both active and passive flexion less than 120° and 50% restriction of the external rotation aside the body
• Visual analog scale of shoulder motion pain greater than 3 on a scale of 10
• No fracture, dislocation, or arthritis in shoulder region

Exclusion Criteria:

• History of or scheduled shoulder or chest surgery
• Significant shoulder trauma within the previous 2 years
• Presence of cervical radiculopathy or other central or peripheral neurologic deficits of the upper limb
• Known shoulder tendon tear or active tendinitis or bursitis as confirmed with US

• Contraindication of low-level light therapy

  1. Pregnancy, cancer, patient with pacemaker, high bleeding tendency, or longterm corticosteroid use.
  2. Poor consciousness state, or patients with sensory impairment
  3. Patients hypersensitive to light
  4. Severe circulatory system disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group (low-level laser therapy with conventional physical therapy); Low-level laser therapy two to three times a week, 10 minutes each time, totally 24 times, for 8 to 10 weeks. Along with conventional physical therapy, two to three times a week, for 12 to 14 weeks.	Device: Low-level laser therapy (LLLT); Low-level laser therapy (LLLT), three time each week, 10 minutes each time, during the first 8 weeks of the treatment trial.; Other: Conventional physical therapy; Conventional physical therapy will be applied three time each week, for 12 weeks
Active Comparator: Conventional group (conventional physical therapy only); Conventional physical therapy, two to three times a week, for 12 to 14 weeks.	Other: Conventional physical therapy; Conventional physical therapy will be applied three time each week, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder range of motion	Shoulder flexion, abduction, external rotation, internal rotation	24 weeks after enrollment
Shoulder pain score	Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)	24 weeks after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional evaluation	Shoulder Pain Disability Index (SPADI)	Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Ultrasound examination	Thickness of coracohumeral ligament and inferior glenohumeral capsule	Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Functional evaluation	Disability of the Arm, Shoulder, and Hand (DASH) questionnaire	Immediate upon enrollment, and 8, 12, 24 weeks after enrollment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: low-level laser therapy; adhesive capsulitis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 202209047DIPA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No