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

NCT ID: NCT06004609

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-21
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-level laser therapy (LLLT)

Intervention Type: DEVICE

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

Conventional physical therapy

Intervention Type: OTHER

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

Conventional group (conventional physical therapy only)

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

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Conventional physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chueh-Hung Wu, MD, PhD

Role: CONTACT

nojred@gmail.com

+886-2312-3456 ext. 66473

En Yang, MD

Role: CONTACT

youngforever0826@gmail.com

+886-2312-3456 ext. 52370

Facility Contacts

Chueh-Hung Wu, MD, PhD

Role: primary

nojred@gmail.com

+886-2312-3456 ext. 66473

Other Identifiers

202209047DIPA

Identifier Type: -

Identifier Source: org_study_id