Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001040954
Ethics application status
Approved
Date submitted
10/08/2020
Date registered
13/10/2020
Date last updated
13/10/2020
Date data sharing statement initially provided
13/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the effect of integrating complementary medicine therapies including acupuncture, naturopathy, yoga and massage therapy for military veterans with chronic pain.
Scientific title
Investigating the effect of integrating complementary medicine therapies including acupuncture, naturopathy, yoga and massage therapy for military veterans with chronic pain : a pilot pragmatic randomised controlled trial.
Secondary ID [1] 301963 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal pain 318523 0
Condition category
Condition code
Alternative and Complementary Medicine 316525 316525 0 0
Other alternative and complementary medicine
Musculoskeletal 316526 316526 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to the standard care described in the control, participants in the intervention arm will also receive referrals to complementary medicine (CM) therapists that have a demonstrable evidence base for pain or musculo-skeletal conditions in general or military or veteran populations. CM practices in this study include acupuncture/Chinese medicine, massage therapy, naturopathic medicine, or yoga. As in the control group, specific referrals for each individual will be determined by the General Practitioner, in collaboration with the other health professionals where appropriate, based on the identified need of the patient. The process of referral will mirror the GP Management Plan (GPMP) processes and policies. To ensure referrals are evidence-based, decision-making tools will be provided by the research team to the clinic which will summarise the level of evidence for the included CM in the treatment of health conditions relevant to the project. All practitioners will need to be eligible for private health insurance rebates under current rules. The acupuncturist, massage therapist and naturopath will provide services at the same clinical location as the GP while the yoga classes will be delivered in a nearby community centre.

The overall duration for each CM therapy interventions is 26 weeks. Following recruitment into the intervention group, participants will be provided an opportunity to book consultations with each CM therapy for an initial consultation. There is no specified maximum amount of consultations or consultation frequency specified for each intervention. Frequency and number of consultations will be dictated by the individual practitioner. The only exception is yoga which will be conducted as a weekly group session. Apart from yoga utilising a session register, monitoring adherence to consultations will be achieved through GO2 Health SMS and phone reminders.

Profession-specific criteria include:
Acupuncture/Chinese medicine - The acupuncturist will be registered with the Chinese Medicine Board of Australia (Australian Health Practitioner Regulation Agency). A typical acupuncture appointment will include formal diagnosis according to Chinese Medicine principles. Treatment will then involve acupuncture, cupping, moxibustion and some Tui Na style massage. Oral herbal or nutritional supplements may be prescribed.

Massage therapy - The massage therapist will be certified with a recognised professional association. A typical massage appointment will provide a 30-60 minutes of tailored remedial manual therapy. Massage therapists at G2H are Diploma or Bachelor of Musculoskeletal Therapy qualified.

Naturopathy: Although the recent NHMRC review noted evidence for naturopathy in the treatment of musculo-skeletal conditions, it noted that due to the unregistered nature of the profession in Australia this was limited to naturopaths with degree training. As such, the naturopath will be a graduate of a four-year Australian naturopathic degree and registered with the Australian Register of Naturopaths and Herbalists. The naturopath may prescribe a range of treatments, most often focusing on nutritional, lifestyle, physical medicine and herbal prescriptions. Examples may include a tailored dietary plan, oral herbal and nutritional supplements, physical exercise program or fact sheets related to sleep, dietary fibre (as examples).

Yoga - The yoga practitioner will be certified with the International Association of Yoga Therapists and will deliver group classes of Hatha yoga. The yoga exercises will be adjusted to the participants’ capabilities, and specific needs, and led by practitioners with substantial experience in the work with ex-military personnel. The yoga intervention will be delivered through a weekly 1 hour session (no maximum number of participants) which is voluntary for all participants in the intervention group. While participants will be encouraged to practice skills and exercises at home, there will be no dictated frequency or duration. It will focus on physical postures, breathing techniques and meditation. A session attendance sheet will be utilised to monitor adherence.
Intervention code [1] 318276 0
Treatment: Other
Intervention code [2] 318545 0
Rehabilitation
Comparator / control treatment
In this instance, usual care will be defined as implementation of a GP Management Plan (GPMP) as developed by the General Practitioner following an Australian Defence Force Health Assessment (ADFHA). The ADFHA will involve completion of the standardised ADFHA documentation as part of a 30 minute appointment with a practice nurse and a 20 minute appointment with a General Practitioner. A GPMP will be developed within 30 days of the ADFHA. In line with accepted practice, the GPMP will be individualised to the specific needs of each participant. This may include any relevant allied health consultations that are eligible for Department of Veterans Affairs (DVA) funding under a GPMP (e.g. physiotherapy, exercise physiology, psychology, dietetics, etc.). Frequency and duration of allied health consultations, over the 26 weeks, will be specified by individual practitioners. There is no minimum or maximum number of consultations required. As participants in both groups are Go2 Health clinic clients, consultations will continue post 26 weeks as per individual allied health practitioner and GP guidance.
Control group
Active

Outcomes
Primary outcome [1] 325052 0
Pain intensity
Timepoint [1] 325052 0
Pain intensity will be assessed by the Brief Pain Inventory (BPI) instrument conducted at recruitment, Week 8, Week 12 and Week 26.
Secondary outcome [1] 385403 0
Quality of life
Timepoint [1] 385403 0
Quality of life will be assessed by two instruments: 12-Item Short Form Health Survey (SF-12) and 5-Item European Quality of Life (EQ-5D) conducted at recruitment, Week 8, Week 12 and Week 26.
Secondary outcome [2] 385404 0
Predicted risk of long term disability
Timepoint [2] 385404 0
Predicted risk of long term disability will be assessed by the Orebro Musculoskeletal Screening Questionnaire (OMSQ) instrument conducted at recruitment and Week 26.
Secondary outcome [3] 385405 0
Pain self-efficacy
Timepoint [3] 385405 0
Pain self-efficacy will be assessed by the Pain Self-Efficacy Questionnaire (PSEQ) instrument conducted at recruitment and Week 26.
Secondary outcome [4] 385406 0
Incremental cost effectiveness ratio
Timepoint [4] 385406 0
Incremental cost effectiveness ratio will be assessed by the EQ-5D instrument conducted at recruitment, Week 8, Week 12 and Week 26. Through the study specific survey, participants will also be asked to note any out of pocket health expenses that were incurred in the last 3 months to recruitment as well as prior to Week 8, Week 12 and Week 26 throughout the trial.
Secondary outcome [5] 386676 0
Safety
Timepoint [5] 386676 0
Safety will be assessed by examining participant medical files for safety issues identified by the participant or health practitioners. The study specific participant case report form includes a section for logging adverse effects throughout the 26 weeks.
Secondary outcome [6] 386677 0
Healthcare utilisation
Timepoint [6] 386677 0
Healthcare utilisation is assessed by examining the participant medical file and case report form. The study specific participant case report form includes several healthcare utilisation related questions which are asked of the participants at recruitment. The two questions related to health services utilisation and out-of-pocket healthcare costs are also asked at Week 8, Week 12 and Week 26. These questions include:
• Are you currently taking any medications (including over the counter)?
• Are you currently taking any complementary medications?
• What other health services have you used in the past?
• Have you ever had out-of-pocket healthcare costs?
Secondary outcome [7] 386678 0
Healthcare behaviours
Timepoint [7] 386678 0
Healthcare behaviours is assessed by examining the participant medical file and case report form. The study specific participant case report form includes several healthcare behaviour related questions which are asked of the participants at recruitment, Week 8, Week 12 and Week 26. These questions include:
• Are you currently smoking? If yes, please provide more detail on usage
• Are you currently utilising any illicit substances? If yes, please provide more detail on usage
• Describe your diet (variety, size, per meal, beverages, takeaways?)
• Do you conduct any form of exercise? If yes, please provide more detail
Secondary outcome [8] 386679 0
Feasibility
Timepoint [8] 386679 0
Feasibility will be assessed post Week 26 by examining the study specific participant case report form, participant medical file and instrument results. As part of the results and discussion of this study, feasibility will look at acceptability, demand and potential future implementation.

Eligibility
Key inclusion criteria
Ex-military personnel who are eligible for treatment of a chronic musculoskeletal pain condition (lasting 6 months or more) through the Department of Veterans Affairs (White Card or Gold Card system), and who consent to involvement in the study, will be included in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are already receiving care through the clinic or who are not eligible for a General Practice Management Plan will be excluded, as pre-existing treatment may be a confounder.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses will be based on the intention-to-treat (ITT) population; that is, each patient assigned a GP Management Plan (GPMP) will be included in the final analysis. Missing values will be substituted using multiple imputation techniques. The primary outcome measure of this study will be pain intensity on week 12. All other outcomes, including feasibility outcomes, will be defined as secondary outcomes, and only exploratory analysis will be conducted. Descriptive statistics will be used to describe the participants’ characteristics. Outcomes (including safety) will be reported descriptively as means and standard deviations (or median and range), or absolute and relative frequencies, and presented separately for each group. Continuous variables will be compared between the groups using t-tests for independent groups (for variables only measured once), and using analyses of (co-)variance (ANCOVA) for repeatedly measured variables, with groups serving as classified variable. Group differences as well as the respective 95% confidence intervals, effect sizes and responder rates (based on cut-off scores) will be reported. Categorical data will be analysed using Chi-square tests. Sensitivity analysis will be conducted to check assumptions in missing data, and Subgroup analysis will be conducted based on characteristics of drop outs vs retained patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/11/2019
Date of last participant enrolment
Anticipated
30/11/2020
Actual
Date of last data collection
Anticipated
30/05/2021
Actual
Sample size
Target
56
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 30908 0
4053 - Everton Park

Funding & Sponsors
Funding source category [1] 306387 0
Charities/Societies/Foundations
Name [1] 306387 0
Defence Health Foundation
Country [1] 306387 0
Australia
Primary sponsor type
Individual
Name
Adjunct Professor Jon Wardle
Address
University of Technology Sydney
Broadway NSW 2007
Country
Australia
Secondary sponsor category [1] 306919 0
None
Name [1] 306919 0
Address [1] 306919 0
Country [1] 306919 0
Other collaborator category [1] 281415 0
Individual
Name [1] 281415 0
Dr Amie Steel
Address [1] 281415 0
University of Technology Sydney
Broadway NSW 2007
Country [1] 281415 0
Australia
Other collaborator category [2] 281416 0
Individual
Name [2] 281416 0
Associate Professor Romy Lauche
Address [2] 281416 0
Southern Cross university
Lismore Campus
Military Road
East Lismore NSW 2480
Country [2] 281416 0
Australia
Other collaborator category [3] 281417 0
Individual
Name [3] 281417 0
Dr Roderick Martin
Address [3] 281417 0
GO2 Health
468 South Pine Rd
Everton Park QLD 4053
Country [3] 281417 0
Australia
Other collaborator category [4] 281418 0
Individual
Name [4] 281418 0
Dr Kieran McCarthy
Address [4] 281418 0
GO2 Health
468 South Pine Rd
Everton Park QLD 4053
Country [4] 281418 0
Australia
Other collaborator category [5] 281419 0
Individual
Name [5] 281419 0
Mr Andrew McLintock
Address [5] 281419 0
University of Technology Sydney
Broadway NSW 2007
Country [5] 281419 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306587 0
University of Technology Sydney Human Research Ethics Committee
Ethics committee address [1] 306587 0
Ethics committee country [1] 306587 0
Australia
Date submitted for ethics approval [1] 306587 0
Approval date [1] 306587 0
25/06/2019
Ethics approval number [1] 306587 0
UTS HREC ETH19-3448
Ethics committee name [2] 306608 0
Departments of Defence and Veterans' Affairs Human Research Ethics Committee
Ethics committee address [2] 306608 0
Ethics committee country [2] 306608 0
Australia
Date submitted for ethics approval [2] 306608 0
Approval date [2] 306608 0
17/07/2019
Ethics approval number [2] 306608 0
DDVA HREC Approval 141-19

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

Contacts
Principal investigator
Name 104374 0
Prof Jon Wardle
Address 104374 0
University of Technology Sydney
Broadway NSW 2007
Country 104374 0
Australia
Phone 104374 0
+61 2 9514 4813
Fax 104374 0
Email 104374 0
[email protected]
Contact person for public queries
Name 104375 0
Jon Wardle
Address 104375 0
University of Technology Sydney
Broadway NSW 2007
Country 104375 0
Australia
Phone 104375 0
+61 2 9514 4813
Fax 104375 0
Email 104375 0
[email protected]
Contact person for scientific queries
Name 104376 0
Jon Wardle
Address 104376 0
University of Technology Sydney
Broadway NSW 2007
Country 104376 0
Australia
Phone 104376 0
+61 2 9514 4813
Fax 104376 0
Email 104376 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.