跳至主要内容
临床试验/NCT06004609
NCT06004609招募中不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Shoulder range of motion

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Shoulder range of motion

时间窗: 24 weeks after enrollment

Shoulder flexion, abduction, external rotation, internal rotation

Shoulder pain score

时间窗: 24 weeks after enrollment

Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)

次要结局

  • Ultrasound examination(Immediate upon enrollment, and 8, 12, 24 weeks after enrollment)
  • Functional evaluation(Immediate upon enrollment, and 8, 12, 24 weeks after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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