Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001344886p
Ethics application status
Submitted, not yet approved
Date submitted
31/08/2021
Date registered
7/10/2021
Date last updated
7/10/2021
Date data sharing statement initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of low-level laser acupuncture for frozen shoulder in adults
Scientific title
Low-level laser acupuncture for frozen shoulder in adults: a randomised crossover feasibility trial
Secondary ID [1] 305181 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frozen shoulder 323455 0
Condition category
Condition code
Musculoskeletal 321004 321004 0 0
Other muscular and skeletal disorders
Alternative and Complementary Medicine 321005 321005 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a crossover feasibility trial with two weeks of interventions and a week washout period in between; the overall duration will be five weeks. During the two weeks of intervention, participants will receive laser acupuncture therapy three times weekly from a licensed acupuncturist at the ECU Acupuncture Research Clinic. They will continue with their usual care treatments for the frozen shoulder if any. Each therapy session will last 30-40 minutes, including preparation, treatment, and conclusion of the treatment. The preparation will involve participant check-in, explain the treatment procedure, asking questions on responses to the previous laser acupuncture, ensure participant comfort, and wear protective glasses. A 3B Laser Pen (200mW, Lorrach, Germany) will be used in the intervention and will have a wavelength of 808 nm in continuous wave mode to be applied to bare skin on the selected acupoints. Each pressure point will receive 20 seconds of energy (4J), with 20 minutes being the maximum treatment time (240J). All participants will have the same acupoints treated. Study-specific questionnaires and session attendance checklists will be used throughout the trial process to monitor the adherence to the intervention.
Intervention code [1] 321580 0
Treatment: Other
Comparator / control treatment
During the 2-week control period, participants will be advised to continue their regular frozen shoulder management (usual care) if any, for example, physiotherapy and medications.
Control group
Active

Outcomes
Primary outcome [1] 328785 0
Recruitment and completion rate, the number of participants referred, eligible, enrolled, withdrawn, and completed will be assessed by an audit of the study database.
Timepoint [1] 328785 0
This outcome will be assessed throughout the 5-week trial.
Primary outcome [2] 329043 0
Treatment adherence and compliance, the number of completed and missed treatment sessions will be assessed by an audit of session attendance checklists.
Timepoint [2] 329043 0
This outcome will be assessed during the intervention period.
Primary outcome [3] 329046 0
Participant attuites towards laser acupuncture, motivation, and challenges to participate, reasons for non-compliance will also be investigated via open-ended questions in the study-specific online surveys. This is a composite outcome.

Timepoint [3] 329046 0
Online surveys will be administered at baseline (T0), post-phase one 2-week intervention (T1), pre-phase two 2-week intervention (T2), and post-phase two 2-week intervention (T3).
Secondary outcome [1] 400339 0
Shoulder pain will be measured using the Short-form McGill Pain Questionaries (SF-MPQ)
Timepoint [1] 400339 0
Four online surveys will be administrated at baseline (T0), post-phase one 2-week intervention (T1), pre-phase two 2-week intervention (T2), and post-phase two 2-week intervention (T3).
Secondary outcome [2] 400368 0
Shoulder function will be measured using the Shoulder Pain and Disability Index (SPADI).
Timepoint [2] 400368 0
Four online surveys will be administrated at baseline (T0), post-phase one 2-week intervention (T1), pre-phase two 2-week intervention (T2), and post-phase two 2-week intervention (T3).
Secondary outcome [3] 400369 0
The shoulder range of motion will be measured by the researcher using a standard Goniometer. The degree of flexion, extension, abduction, internal rotation and external rotation will be assessed. This is a composite outcome.
Timepoint [3] 400369 0
The outcome will be measured at baseline (T0), post-2-week phase one intervention (T1), pre-2-week phase two intervention (T2), and post-2-week phase two intervention (T3).
Secondary outcome [4] 400370 0
Health-related quality of life will be assessed using the 12-item Short-Form Health Survey (SF-12).
Timepoint [4] 400370 0
Four online surveys will be administrated at baseline (T0), post-2-week phase one intervention (T1), pre-2-week phase two intervention (T2), and post-2-week phase two intervention (T3).
Secondary outcome [5] 400371 0
The safety of using laser acupuncture for frozen shoulder will be investigated by the number of adverse events and types of adverse events (eg. tingling, dizziness, and dryness in the mouth, assessed by participant self-report).
Timepoint [5] 400371 0
The safety will be assessed on each visit during the entire five weeks of the trial.
Secondary outcome [6] 401260 0
Participant's ability to work and perform regular activities will be assessed using the Work productivity and activity Index-Specific Health Problem Questionnaire (WPAI:SHP).
Timepoint [6] 401260 0
At baseline (T0), post-2-week phase one intervention (T1), pre-2-week phase two intervention (T2), and post-2-week phase two intervention (T3).
Secondary outcome [7] 401279 0
Participants’ non-pharmacologic therapy preferences.
Timepoint [7] 401279 0
This outcome will be measured at baseline (T0).

Eligibility
Key inclusion criteria
The inclusion criteria are adults diagnosed with frozen shoulder (maximum of 12 months prior to inclusion), currently experiencing moderate or severe shoulder pain and restricted shoulder movement (greater than or equal to 5 on an 11-point Pain Visual Analogue Scale, and greater than or equal to 50 points for the Shoulder Pain and Disability Index), able to understand and provide information, and able to provide informed consent.

Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria are:
• Diagnosed with other comorbidities (e.g., stroke, rheumatoid arthritis, and polymyalgia).
• Previously had manipulation on the affected shoulder under anaesthesia over the past 12 months.
• Previously had corticosteroid injection on the affected shoulder over the past one month.
• Have a history of major shoulder injury or surgery.
• Have cancer.
• Pregnant.
• Highly sensitive to light.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomly assigned to group A (usual care + LLLA) and group B (usual care) using the block randomisation method. The allocation sequence will be prepared by a statistician who will be blinded to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence numbers of each participant will be generated through computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the primary outcome, the rates of recruitment, completion, adherence will be calculated and presented. The characteristics of participants, reasons for withdrawals from the trial and miss treatment sessions, and adverse events will be summarised. For the secondary outcomes, the data analysis will be carried out by an independent statistician using R. A linear mixed model will be used to assess the changes in the secondary outcomes before and after the interventions. The analysis will be adjusted for potential confounding factors (e.g., age, gender, usual care received). Normality assumptions will be assessed using the Shapiro-Wilk test. Statistical significance will be set at an alpha level of 0.05. Corrections will be applied to all analysed outcomes to account for multiple outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 309564 0
University
Name [1] 309564 0
Edith Cowan University
Country [1] 309564 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive, Joondalup, WA 6027
Country
Australia
Secondary sponsor category [1] 310565 0
Commercial sector/Industry
Name [1] 310565 0
Wisdom Health Group
Address [1] 310565 0
Unit 7/ 288 Lord Street, Highgate, WA 6007
Country [1] 310565 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309344 0
Edith Cowan University’s Human Research Ethics Committee
Ethics committee address [1] 309344 0
Ethics committee country [1] 309344 0
Australia
Date submitted for ethics approval [1] 309344 0
20/08/2021
Approval date [1] 309344 0
Ethics approval number [1] 309344 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113842 0
Ms Rong Wang
Address 113842 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Drive, Joondalup, WA 6027
Country 113842 0
Australia
Phone 113842 0
+61423903559
Fax 113842 0
Email 113842 0
[email protected]
Contact person for public queries
Name 113843 0
Rong Wang
Address 113843 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Drive, Joondalup, WA 6027
Country 113843 0
Australia
Phone 113843 0
+61423903559
Fax 113843 0
Email 113843 0
[email protected]
Contact person for scientific queries
Name 113844 0
Rong Wang
Address 113844 0
Edith Cowan University School of Nursing and Midwifery
270 Joondalup Drive, Joondalup, WA 6027
Country 113844 0
Australia
Phone 113844 0
+61423903559
Fax 113844 0
Email 113844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.