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

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004609
• Other study ID #: 202209047DIPA
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: National Taiwan University Hospital
• Contact: Chueh-Hung Wu, MD, PhD
• Phone: +886-2312-3456
• Email: nojred[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder range of motion	Shoulder flexion, abduction, external rotation, internal rotation	24 weeks after enrollment
Primary	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	Functional evaluation	Shoulder Pain Disability Index (SPADI)	Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Secondary	Ultrasound examination	Thickness of coracohumeral ligament and inferior glenohumeral capsule	Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Secondary	Functional evaluation	Disability of the Arm, Shoulder, and Hand (DASH) questionnaire	Immediate upon enrollment, and 8, 12, 24 weeks after enrollment