Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000643178
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
30/04/2019
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain: a pilot randomised controlled trial
Scientific title
The effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in adults with chronic non-specific low back pain: a pilot randomised controlled trial using outcomes measured by the Oswestry Disability Index and the PROMIS scale V1.2 – Global Health
Secondary ID [1] 297924 0
None
Universal Trial Number (UTN)
U1111-1231-4377
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-specific low back pain 312312 0
Condition category
Condition code
Alternative and Complementary Medicine 310875 310875 0 0
Other alternative and complementary medicine
Musculoskeletal 310876 310876 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Osteopathic Healthcare involves:
One on one face to face 45 minute consultations, once a week for 4 weeks, applied by university masters osteopathy student under registered osteopath supervision, described fully on case form.
Manual Therapy
Practitioner to choose from a mixture of the following, depending on patient presentation, tissue state and patient preferences: soft tissue/myofascial techniques, muscle energy/stretching, articulation, high velocity low amplitude manipulation, indirect/positional release, craniosacral.
Education
Practitioner describe to participant within the 45 minute consultation what was found and how this relates to their pain and function. An outline of current understanding of chronic pain is given, a description of the participants likely pain mechanism (whether peripheral or central or combination), and reassurance about the prognosis of chronic low back pain.
Advice
Participant is given regarding specific rehabilitative exercises that will address the specific osteopathic diagnosis (stretching, strengthening, balance and coordination), as well as postural and ergonomic advice if required.
Intervention code [1] 314146 0
Diagnosis / Prognosis
Intervention code [2] 314147 0
Treatment: Other
Comparator / control treatment
Standard care based on international evidence based guidelines for primary care, including education, reassurance and advice about activities.
Practitioners discuss the nature of the subjects pain and what is known about chronic non-specific low back pain. The subject is given standard education and advice that is based on international guidelines for primary care practitioners – including pain science and activities that are appropriate.
American College of Physicians. (2017). Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Retrieved from: https://chiropractors.asn.au/images/Quaseem_2017_ACP_LBP_guidelines.pdf\
Institute of Health Economics. (2015). Evidence-informed primary care management of low back pain: clinical practice guidelines. Retrieved from: http://www.topalbertadoctors.org/download/1885/LBPguideline.pdf?_20170303111012
National Institute of Health and Care Excellence. (2016). Low back pain and sciatica in over 16s: assessment and management. Retrieved from https://www.nice.org.uk/guidance/ng59/chapter/Recommendations
The Royal Australian College of General Practitioners. (2018). Clinical guidelines: musculoskeletal. Retrieved from: https://www.racgp.org.au/
Control group
Active

Outcomes
Primary outcome [1] 319697 0
Oswestry Disability Index
Timepoint [1] 319697 0
Assessed before treatment series begins, immediately after the series of 4 consultations, at 2 weeks following end of treatment series, and at 6 weeks following end of treatment series
Primary outcome [2] 319698 0
PROMIS v1.2 Global health
Timepoint [2] 319698 0
Assessed before treatment series begins, immediately after the series of 4 consultations, at 2 weeks following end of treatment series, and at 6 weeks following end of treatment series
Secondary outcome [1] 369211 0
Pain level by visual analogue scale
Timepoint [1] 369211 0
Assessed before treatment series begins, immediately after the series of 4 consultations, at 2 weeks following end of treatment series, and at 6 weeks following end of treatment series

Eligibility
Key inclusion criteria
Low back pain (between lower ribs to buttocks)
History of LBP longer than 3 months
Average severity ranked between 3-7 on Visual Analogue Scale
Absence of diagnosis of pathology causing pain (malignancy, inflammatory disease, IV disc prolapse, fracture/trauma)
Proficiency in English language
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Confirmed pathological cause of LBP,
Acute or subacute pain (less than 12 weeks),
Severe pain limiting ambulation and/or exercise (ie above average 7 on VAS),
Co-morbidities that contraindicate manual therapy (list from intake form),
Post-surgical patients,
Moderate to severe depression based on the Patient Health Questionnaire (PHQ-9)
Insurance claims (workers compensation or concurrent litigation)

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)
Central block randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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
Efficacy
Statistical methods / analysis
The statistical approach will be undertaken as an intention to treat analysis. The statistical analysis will be undertaken using a multivariate approach setting treatment (osteopathy and education) and time (baseline, end of treatment) as factors within the analysis. The effect size will be also be determined by Cohen d following a Cochrane Back Review Group guideline.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2019
Date of last participant enrolment
Anticipated
1/07/2019
Actual
Date of last data collection
Anticipated
6/09/2019
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 26235 0
2480 - Lismore
Recruitment postcode(s) [2] 26236 0
4225 - Coolangatta

Funding & Sponsors
Funding source category [1] 302440 0
University
Name [1] 302440 0
Southern Cross University
Country [1] 302440 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
PO Box 157 Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 302342 0
None
Name [1] 302342 0
Address [1] 302342 0
Country [1] 302342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303109 0
Southern Cross University Human Ethics
Ethics committee address [1] 303109 0
PO Box 157 Lismore NSW 2480
Ethics committee country [1] 303109 0
Australia
Date submitted for ethics approval [1] 303109 0
22/11/2017
Approval date [1] 303109 0
14/12/2018
Ethics approval number [1] 303109 0
ECN-18-215

Summary
Brief summary
This is a pragmatic trial designed to test the effectiveness of osteopathic healthcare compared to a standardised education and activity care plan in chronic non-specific low back pain. It is a pragmatic design as it is testing two active interventions that people commonly seek for management of musculoskeletal pain, and the interventions are applied with real-world authenticity. The study aims to see if these interventions improve the pain and health status of participants, and whether the osteopathic healthcare intervention is any more effective than the standardised exercise and activity care plan.
The core elements of the osteopathic healthcare intervention has been established through research, and includes assessment of musculoskeletal function, manual therapy, education, therapeutic exercise and health promotion advice. The exercise and activity care plan intervention is based on evidence based guidelines for chronic low back pain. After screening for the inclusion and exclusion criteria, participants will complete the first outcome measurements, and then be randomised into groups and receive four weekly consultations. The second outcome measurement will be completed immediately after the final consultation, the third 2 weeks after the interventions and a fourth 6 weeks after the end of interventions in order to test short and medium terms outcomes. Statistical approach is by Intention To Treat, and analysis will be undertaken using a multivariate approach and calculating effect sizes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92506 0
Dr Paul Orrock
Address 92506 0
Southern Cross University PO Box 157
Lismore 2480
New South Wales
Country 92506 0
Australia
Phone 92506 0
+61 408995253
Fax 92506 0
Email 92506 0
[email protected]
Contact person for public queries
Name 92507 0
Dr Paul Orrock
Address 92507 0
Southern Cross University PO Box 157
Lismore 2480
New South Wales
Country 92507 0
Australia
Phone 92507 0
+61 408995253
Fax 92507 0
Email 92507 0
[email protected]
Contact person for scientific queries
Name 92508 0
Dr Paul Orrock
Address 92508 0
Southern Cross University PO Box 157
Lismore 2480
New South Wales
Country 92508 0
Australia
Phone 92508 0
+61 408995253
Fax 92508 0
Email 92508 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
The ethics approval did not give this consent


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1829Ethical approval    377362-(Uploaded-09-04-2019-19-04-12)-Study-related document.pdf



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.