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

NCT06004609 | Unknown

• 1 other identifier: 202209047DIPA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis of Shoulder

Keywords

adhesive capsulitis; low-level laser therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Functional evaluation

  Immediate upon enrollment, and 8, 12, 24 weeks after enrollment

• Ultrasound examination

  Immediate upon enrollment, and 8, 12, 24 weeks after enrollment

• Functional evaluation

  Immediate upon enrollment, and 8, 12, 24 weeks after enrollment

Study Arms (2)

Treatment group (low-level laser therapy with conventional physical therapy)

EXPERIMENTAL

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); Other: Conventional physical therapy

Conventional group (conventional physical therapy only)

ACTIVE COMPARATOR

Conventional physical therapy, two to three times a week, for 12 to 14 weeks.

Other: Conventional physical therapy

Interventions

Low-level laser therapy (LLLT) DEVICE

Low-level laser therapy (LLLT), three time each week, 10 minutes each time, during the first 8 weeks of the treatment trial.

Treatment group (low-level laser therapy with conventional physical therapy)

Conventional physical therapy OTHER

Conventional physical therapy will be applied three time each week, for 12 weeks

Conventional group (conventional physical therapy only); Treatment group (low-level laser therapy with conventional physical therapy)

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Chueh-Hung Wu, MD, PhD

CONTACT

+886-2312-3456; nojred@gmail.com

En Yang, MD

CONTACT

+886-2312-3456; youngforever0826@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 22, 2023
• Study Start: July 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 31, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)