Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000647730p
Ethics application status
Submitted, not yet approved
Date submitted
5/04/2022
Date registered
3/05/2022
Date last updated
3/05/2022
Date data sharing statement initially provided
3/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Alternative and complementary medicine as a pathway to care for New Zealand military Veterans with pain.
Scientific title
The efficacy of alternative and complementary medicine as a pathway to care for New Zealand military Veterans experiencing pain and distress.
Secondary ID [1] 306817 0
R-LHR-2022-185287
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal pain 325902 0
Psychological distress 325903 0
Condition category
Condition code
Musculoskeletal 323211 323211 0 0
Other muscular and skeletal disorders
Mental Health 323212 323212 0 0
Anxiety
Mental Health 323213 323213 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture (BA), a form of auriculotherapy where a sequence of small gold plated needles is placed in the ear, typically remaining for three days, when the patient is told to remove them. BA will be delivered weekly over a period of 12 weeks in the clinic of the practitioner.
Acceptance and Commitment therapy will be administered as Focussed Acceptance and Commitment therapy (FACT), which uses acceptance and mindfulness strategies to help people transform their relationship with unwanted, distressing experiences. This will be delivered in tandem with BA, usually with 4 sessions, meaning with 4 sessions over the first 4 weeks. FACT will be applied in tandem with BA, each session of both expected to last for up to one hour.
Rongoa Maori, traditional Maori healing, will be available as an option to those entering the treatment arm, also over 12 weekly sessions. It will be delivered by trained Practitioners at their own , who will determine which intervention is appropriate: Romiromi, the physical bodywork that uses Haemata and Haematua (acupressure points) to release trapped energy in the body that is causing ailments or illness; Mirimiri, which Includes Korero (discussions), Takutaku (incantations), Waiata (song) and Whatumanawa accessing Taha Wairua (metaphysical or spiritual elements) associated with the injury or illness, or Rongoa Wairaku - plant medicines applied either topically or ingested to support healing. Each session is also expected to last for up to one hour.
Practitioners will be asked to confirm that each session has been completed according to the protocol.
Intervention code [1] 323284 0
Treatment: Other
Comparator / control treatment
"Usual care" in other words how Veterans usually manage their health condition, or as advised by their GP at the first visit.
Control group
Active

Outcomes
Primary outcome [1] 330964 0
The primary outcome instrument will be distress, assessed using the 12 item General Health Questionnaire (GHQ-12), scored using a four point scale (0-3) and summing the 12 items to give a total score, with higher scores indicating elevated distress.
Timepoint [1] 330964 0
Baseline, and at 12 weeks after completion of the final session
Secondary outcome [1] 408298 0
Pain, assessed by The Dallas Pain Questionnaire (DPQ), a 16-item visual analogue tool for the purpose of evaluating a subject’s cognitions about the effect (%) of chronic pain on four aspects of their lives: 1) daily activities including pain and intensity, personal care, lifting, walking, sitting, standing, and sleeping; 2) work and leisure activities including social life, travelling, and vocational; 3) anxiety-depression; and 4) social interest that includes interpersonal relationship, social support, and punishing responses.
Timepoint [1] 408298 0
Measured at baseline, and 12 weeks, 24 and 36 weeks after the start of treatment.
Secondary outcome [2] 408300 0
Disability, measured using the Sheehan Disability Scale, with three items rated on an 11-point scale ranging from 0 (not at all) to 10 (extremely). This measures impairment in work, social, and family settings, and is sensitive to symptom change and differences between active and control treatments.
Timepoint [2] 408300 0
Measured at baseline, and 12 weeks, 24 and 36 weeks after the start of treatment.
Secondary outcome [3] 408301 0
Sleep quality, assessed with the Sleep Condition Indicator (SCI). This assesses insomnia as described in the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-V). The SCI consists of eight items rated from 0-4, the total scores being scaled to a range of 0 to 10, where higher scores represent better sleep.
Timepoint [3] 408301 0
Measured at baseline and at 36 weeks after first treatment
Secondary outcome [4] 408828 0
Symptoms of Post-Traumatic Stress will be assessed using the post-traumatic stress disorder (PTSD) checklist for DSM 5, the PCL-5. The PCL-5 includes 20 items that ask about DSM-5 symptoms of PTS, with response options ranging from 1 ‘Not at all’ to 5 ‘Extremely’.
Timepoint [4] 408828 0
Baseline and at 36 weeks after start of treatment.
Secondary outcome [5] 408829 0
Psychological flexibility as measured with the 10-item AAQ-II.[20] Items are answered on a 7-point scale, with options ranging from ‘never true’ to ‘always true’. The items are summed to obtain a total score (possible range 10 to 70), with higher scores indicative of greater psychological flexibility
Timepoint [5] 408829 0
At baseline, and at 36 weeks after start of treatment.

Eligibility
Key inclusion criteria
Eligible participants will be Veterans, defined as anyone who has served in the military, presenting with multiple or complex symptoms with a pattern corresponding to multi system illness, with at least one musculoskeletal symptom (e.g. joint pain, joint stiffness, muscle aches/pains) and at least one psychological symptom (e.g. sleeping difficulties, avoidance, feeling distant. unrefreshing sleep distressing dreams)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with levels of distress requiring more immediate intervention.

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)
Randomisation by computer after completing consent to participation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer randomisation by the RedCap system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary end-point is reduction in distress at 12 weeks, using a t-test comparing GHQ12 scores between the two arms. Regression analysis will be used to adjust for any baseline imbalances and for the secondary analyses looking at change over time (allowing for repeated measures) for all outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
31/01/2023
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment outside Australia
Country [1] 24701 0
New Zealand
State/province [1] 24701 0
National

Funding & Sponsors
Funding source category [1] 311152 0
Charities/Societies/Foundations
Name [1] 311152 0
Lottery Health
Country [1] 311152 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Research and Enterprise, East Wing, Centre For Innovation Building, 87 St David Street, Dunedin 9017, New Zealand
Country
New Zealand
Secondary sponsor category [1] 312501 0
None
Name [1] 312501 0
Address [1] 312501 0
Country [1] 312501 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310680 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 310680 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 310680 0
New Zealand
Date submitted for ethics approval [1] 310680 0
19/04/2022
Approval date [1] 310680 0
Ethics approval number [1] 310680 0

Summary
Brief summary
This intervention is for New Zealand Military Veterans, who seem to suffer from complex problems including muscle aches and pains, joint stiffness, poor sleep and avoiding doing things or situations. Underlying these seems to be post traumatic stress and barriers to seeking treatment such as stoicism and the perceived lack of effective services. Our hypothesis is that we can overcome the barriers by providing acceptable forms of treatment, and that either 'battlefield acupuncture,' in which the acupuncture points are in the ear, in tandem with a particular form of talking therapy, Action and Commitment therapy (ACT), or Rongoa Maori, traditional Maori healing, will be more effective ways to manage their symptoms that 'usual care,' how they usually look after themselves. We are therefore carrying out a randomised clinical trial to see whether either Acupuncture and ACT, or Rongoa Maori, will be more effective than 'usual care' in reducing distress, pain, disability, symptoms of post-traumatic stress and avoidance, and increasing their psychological flexibility and sleep quality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118494 0
A/Prof David McBride
Address 118494 0
Department of Preventive and Social Medicine,
Ground Floor, Adams Building,
18 Frederick Street,
Dunedin 9017.
Country 118494 0
New Zealand
Phone 118494 0
+64 272 253 5451
Fax 118494 0
Email 118494 0
david.mcbride@otago.ac.nz
Contact person for public queries
Name 118495 0
A/Prof David McBride
Address 118495 0
Department of Preventive and Social Medicine,
Ground Floor, Adams Building,
18 Frederick Street,
Dunedin 9017.
Country 118495 0
New Zealand
Phone 118495 0
+64 272 253 5451
Fax 118495 0
Email 118495 0
david.mcbride@otago.ac.nz
Contact person for scientific queries
Name 118496 0
A/Prof David McBride
Address 118496 0
Department of Preventive and Social Medicine,
Ground Floor, Adams Building,
18 Frederick Street,
Dunedin 9017.
Country 118496 0
New Zealand
Phone 118496 0
+64 272 253 5451
Fax 118496 0
Email 118496 0
david.mcbride@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified data underlying the published results (i.e. the questionnaire data)
When will data be available (start and end dates)?
From 1st July 2023 to 31st June 2028.
Available to whom?
To those researchers who provide a methodologically sound protocol.
Available for what types of analyses?
For meta-analysis, or to those adopting a similar protocol, i.e. using similar instruments.
How or where can data be obtained?
Qualified researchers may apply for data access with the research team at veterans. health@otago.ac.nz and/or hdecs@moh.govt.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15647Study protocol  david.mcbride@otago.ac.nz Attached 383859-(Uploaded-05-04-2022-10-15-27)-Study-related document.docx
15648Statistical analysis plan  david.mcbride@otago.ac.nz The primary outcome instrument will be the change ... [More Details]
15649Informed consent form  david.mcbride@otago.ac.nz 383859-(Uploaded-28-04-2022-07-13-46)-Study-related document.doc
15650Ethical approval  david.mcbride@otago.ac.nz Application submitted 19th April 2022



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.