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Trial registered on ANZCTR


Registration number
ACTRN12611001100987
Ethics application status
Approved
Date submitted
18/10/2011
Date registered
24/10/2011
Date last updated
13/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A quasi-experimental clinical outcomes-based audit of manual therapy management for mechanical spinal pain within a substance-misuse rehabilitation therapeutic community. “The Palmerston-Murdoch Project”.
Scientific title
A parallel, longitudinal, non-randomised comparison of manual care in addition to usual care, with usual care which may include medication for residents of a therapeutic community (with spinal pain) using self-perceived clinical outcomes and satisfaction with care, along with student perceptions of the service oriented placement.
Secondary ID [1] 273241 0
Nil
Universal Trial Number (UTN)
Trial acronym
P-MP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal pain 278984 0
Condition category
Condition code
Alternative and Complementary Medicine 279160 279160 0 0
Other alternative and complementary medicine
Musculoskeletal 279161 279161 0 0
Other muscular and skeletal disorders
Other 279165 279165 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Usual chiropractic care (a package of manual and manipulative therapy) (Experimental Group) Duration and frequency of treatment; 1 x 20 minute chiropractic session per week for 6 weeks. Administered by chiropractic interns. Treatment will consist of a package of conservative care that usually includes manual and manipulative therapy, soft tissue therapy, exercise prescription and rehabilitation programmes, at the discretion of the practitioner and based on the clinical presentation of the patient. Arm 2: Usual care (Comparison Group) Usual care for spinal pain which may include medication and/or advice and is provided by practising General Practitioners in a standard medical practice setting. Arm 3: Chiropractic Interns (5th year undergraduate students) at Murdoch University. Students will be surveyed after they have completed the placement on their attitudes toward the placement and community service. This arm of the study involves the intern/student completing online a series of questions about the educational benefit along with the attitudes of the intern toward community service.
Intervention code [1] 269575 0
Treatment: Other
Comparator / control treatment
Usual Care (UC) for spinal pain which may involve medication and/or advice delivered by General Practitioners in standard medical practice setting.
Control group
Active

Outcomes
Primary outcome [1] 279802 0
RAND-36
Recorded at initial visit and repeated after intervention.

R-36 measures health-related quality of life; eight health constructs: physical functioning, role limitations caused by physical health problems, pain, general health perceptions, emotional well-being, role limitations caused by emotional problems, social functioning, and energy/fatigue.
Timepoint [1] 279802 0
Baseline and at 6 weeks
Primary outcome [2] 279803 0
Patient Satisfaction Questionnaire
Timepoint [2] 279803 0
6 weeks
Primary outcome [3] 279804 0
Student Perception of Service-Learning Experience (SPSLE)
Timepoint [3] 279804 0
End of Placement
Secondary outcome [1] 294481 0
Nil
Timepoint [1] 294481 0
Nil

Eligibility
Key inclusion criteria
Experimental Groups:
1.Residents of therapeutic community who volunteer for the study and provide informed consent to receive usual chiropractic care who are suffering from spinal pain.

2.Chiropractic Interns (5th year undergraduate students)

Control Group:
Residents of therapeutic community who volunteer for the study and provide informed consent and receive usual medical care for spinal pain.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No – all participants will be receiving at least usual care for spinal pain

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Self selected
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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 270048 0
University
Name [1] 270048 0
Murdoch University
Address [1] 270048 0
Murdoch University School of Chiropractic and Sports Science
South St
MURDOCH WA 6150
AUSTRALIA
Country [1] 270048 0
Australia
Funding source category [2] 270049 0
Other Collaborative groups
Name [2] 270049 0
Palmerston Association (Non Government Organisation)
Address [2] 270049 0
PO BOX 8241
Subiaco East WA 6008
AUSTRALIA
Country [2] 270049 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Murdoch University School of Chiropractic and Sports Science
South St
MURDOCH WA 6150
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 269018 0
Other Collaborative groups
Name [1] 269018 0
Palmerston Association (Non Government Organisation)
Address [1] 269018 0
PO BOX 8241
Subiaco East WA 6008
AUSTRALIA
Country [1] 269018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272005 0
Murdoch University Research Ethics Office
Ethics committee address [1] 272005 0
Division of Research and Development
Chancellery Building
South Street
MURDOCH WA 6150
Ethics committee country [1] 272005 0
Australia
Date submitted for ethics approval [1] 272005 0
Approval date [1] 272005 0
02/08/2011
Ethics approval number [1] 272005 0
2011/051

Summary
Brief summary
Chiropractic care is currently being provided by chiropractic Interns, under supervision, to residents of Palmerston Farm a therapeutic community, with this service having been provided to date for over 4 years. This study will measure the outcomes of this service in terms of students’ perception of the service and residents’ satisfaction with care and treatment outcomes. All eligible participants (interns and residents of Palmerston Farm) will be provided an Information Sheet concerning the project and will be required to provide written informed consent prior to participation in the study. Volunteers for the treatment part of the study will undergo a standard case history and physical examination, including a relevant orthopaedic evaluation and consent to procedures. Patients that do not demonstrate any contradictions to chiropractic care (manual and manipulative therapy) will then enter the study and undergo chiropractic care, as required. Treatment will consist of conservative care such as manual and manipulative therapy, soft tissue therapy, exercise prescription and rehabilitation programmes, applied based on the presentation of the patient. Treatment will be provided on a weekly basis to those residents (patients) that volunteer for the study, over a 6-week period. Hence, each participating patient will typically receive 6 treatments over a 6-week period. Participants in the control group will anonymously complete PSQ and R-36 forms. Data will be collected at baseline and at the end of each participant course of treatment, or after six visits whichever is sooner, using the stated outcome measures; PSQ and RAND-36. Data will be collected from the participating chiropractic Interns at the end of their outreach programme at Palmerston Farm; using a modified SPSLE. The questionnaires used for this data collection will be provided online using the so called 'SurveyMonkey' tool. No identifiable risks or problems are anticipated to arise as a result of the implementation of this study, beyond the usual issues that may be encountered when offering this care in the context of a substance misuse recovery facility.
Trial website
Trial related presentations / publications
Amorin-Woods, L., Parkin-Smith, G., Cascioli, V., & Kennedy, D. (2016). Manual care of residents with spinal pain within a therapeutic community. Ther Communities, 37(3), E-pub ahead of print.
Public notes

Contacts
Principal investigator
Name 33276 0
Dr Lyndon Amorin-Woods
Address 33276 0
Murdoch University
South St MURDOCH WA 6150
Country 33276 0
Australia
Phone 33276 0
+61 8 9360 1267
Fax 33276 0
Email 33276 0
L.Woods@murdoch.edu.au
Contact person for public queries
Name 16523 0
Dr Lyndon Amorin-Woods
Address 16523 0
School of Chiropractic & Sports Science
Murdoch University
South St
MURDOCH WA 6150
Country 16523 0
Australia
Phone 16523 0
+61893601267
Fax 16523 0
Email 16523 0
thechiro@iinet.net.au
Contact person for scientific queries
Name 7451 0
Dr Gregory Parkin-Smith
Address 7451 0
School of Chiropractic & Sports Science
Murdoch University
South St
MURDOCH WA 6150
Country 7451 0
Australia
Phone 7451 0
+618 93601389
Fax 7451 0
Email 7451 0
g.parkin-smith@murdoch.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary