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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adhesive Capsulitis of Shoulder

Intervention / Treatment
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* Device: Low-level laser therapy (LLLT)
* Other: Conventional physical therapy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesive capsulitis, low-level laser therapy