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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06004609
Collaborator
(none)
50
1
2
17.4
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Low-level laser therapy (LLLT)
  • Other: Conventional physical therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
Actual Study Start Date :
Jul 21, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group (low-level laser therapy with conventional physical therapy)

Low-level laser therapy three times a week, 10 minutes each time, for 8 weeks. Along with conventional physical therapy, three times a week, for 12 weeks.

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

Active Comparator: Conventional group (conventional physical therapy only)

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

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

Outcome Measures

Primary Outcome Measures

  1. Shoulder range of motion [24 weeks after enrollment]

    Shoulder flexion, abduction, external rotation, internal rotation

  2. Shoulder pain score [24 weeks after enrollment]

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

Secondary Outcome Measures

  1. Functional evaluation [Immediate upon enrollment, and 8, 12, 24 weeks after enrollment]

    Shoulder Pain Disability Index (SPADI)

  2. Ultrasound examination [Immediate upon enrollment, and 8, 12, 24 weeks after enrollment]

    Thickness of coracohumeral ligament and inferior glenohumeral capsule

  3. Functional evaluation [Immediate upon enrollment, and 8, 12, 24 weeks after enrollment]

    Disability of the Arm, Shoulder, and Hand (DASH) questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT06004609
Other Study ID Numbers:
  • 202209047DIPA
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023