Adhesive Capsulitis of ShoulderNCT06004609
Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
A study testing Low-level laser therapy (LLLT) and Conventional physical therapy in people with Adhesive Capsulitis of Shoulder, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Adhesive Capsulitis of Shoulder
- What is being tested?
- Low-level laser therapy (LLLT) and Conventional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Jul 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Poor consciousness state, or patients with sensory impairment
- Patients hypersensitive to light
- Severe circulatory system disorder
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chueh-Hung Wu, MD, PhD, +886-2312-3456 ext. 66473, nojred@gmail.com
En Yang, MD
About this study
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.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Low-level laser therapy (LLLT), Conventional physical therapy
- Keywords
- adhesive capsulitis, low-level laser therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapy (LLLT)Device
Low-level laser therapy (LLLT), three time each week, 10 minutes each time, during the first 8 weeks of the treatment trial.
Conventional physical therapyOther
Conventional physical therapy will be applied three time each week, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (low-level laser therapy with conventional physical therapy) | Experimental | 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. Receives: Device: Low-level laser therapy (LLLT); Other: Conventional physical therapy |
| Conventional group (conventional physical therapy only) | Active comparator | Conventional physical therapy, two to three times a week, for 12 to 14 weeks. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder range of motion
Shoulder flexion, abduction, external rotation, internal rotation
Measured: 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)
Measured: 24 weeks after enrollment
Secondary outcomes (3)
Functional evaluation
Shoulder Pain Disability Index (SPADI)
Measured: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Ultrasound examination
Thickness of coracohumeral ligament and inferior glenohumeral capsule
Measured: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Functional evaluation
Disability of the Arm, Shoulder, and Hand (DASH) questionnaire
Measured: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start21 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004609
- Sponsor's protocol ID
- 202209047DIPA
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Large-area Low-level Light Therapy for Treating Adhesive Capsulitis of the Shoulder
- ClinicalTrials.gov ID
- NCT06004609
- Acronym / sponsor ID
- 202209047DIPA
- Conditions
- Adhesive Capsulitis of Shoulder
- Keywords
- adhesive capsulitis, low-level laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (low-level laser therapy with conventional physical therapy) | Experimental | Device: Low-level laser therapy (LLLT), Other: Conventional physical therapyLow-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. |
| Conventional group (conventional physical therapy only) | Active comparator | Other: Conventional physical therapyConventional physical therapy, two to three times a week, for 12 to 14 weeks. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Treatment group (low-level laser therapy with conventional physical therapy) |
| Conventional physical therapyConventional physical therapy will be applied three time each week, for 12 weeks | Other | Conventional group (conventional physical therapy only), Treatment group (low-level laser therapy with conventional physical therapy) |
Primary outcome
Shoulder range of motion
Time frame: 24 weeks after enrollment
Shoulder flexion, abduction, external rotation, internal rotation
Shoulder pain score
Time frame: 24 weeks after enrollment
Visual analogue scale for pain during shoulder motion (scale from 0 to 10, with higher scores mean worse outcome)
3 secondary outcomes
Functional evaluation
Time frame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Ultrasound examination
Time frame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Functional evaluation
Time frame: Immediate upon enrollment, and 8, 12, 24 weeks after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy (LLLT) and Conventional physical therapy in people with Adhesive Capsulitis of Shoulder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chueh-Hung Wu, MD, PhD (+886-2312-3456 ext. 66473, nojred@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder range of motion (time frame: 24 weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.