Clinical trial NCT06004609: Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
Official title: Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Keywords: adhesive capsulitis
low-level laser therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Shoulder range of motion
timeFrame: 24 weeks after enrollment
measure: Shoulder pain score
timeFrame: 24 weeks after enrollment
Secondary outcomes:
measure: Functional evaluation
timeFrame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
measure: Ultrasound examination
timeFrame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
measure: Functional evaluation
timeFrame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: