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Trial registered on ANZCTR


Registration number
ACTRN12613001257752
Ethics application status
Not yet submitted
Date submitted
14/11/2013
Date registered
18/11/2013
Date last updated
18/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic care for adolescent low back pain: a pilot study
Scientific title
Chiropractic care for adolescent low back pain: a sham controlled feasibility study
Secondary ID [1] 283492 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adolescent low back pain 290410 0
Condition category
Condition code
Musculoskeletal 290800 290800 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290922 290922 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chiropractic group: the chiropractic care protocol will be semi-standardised, involving both fixed components and any other treatment the chiropractors deem necessary. The fixed components have been derived from a Delphi study undertaken to identify elements of best chiropractic practice for adolescent low back pain, and comprise: spinal manipulation in the lumbo-pelvic area; mobilisation in the lumbo-pelvic area; advice to stay active; advice about modification of activities; and recommending back-specific exercises and general exercise. The chiropractors will be encouraged to use all of the fixed components in each consultation, but may use their discretion whether they are used on a particular patient or not. Four treatments will provided to each participant. The initial consultation will include a detailed medical history assessment and will last for about one hour. The three subsequent treatments, spaced at weekly intervals, will last for about 20-30 minutes.
Intervention code [1] 288198 0
Treatment: Other
Comparator / control treatment
Sham group: participants will receive de-tuned ultrasound and de-tuned Activator treatment by the chiropractor to the regions where spinal pain is experienced. To increase the perceived “hands on” credibility, the chiropractor will be trained to gently place one hand on an area adjacent to the participant’s spine while delivering the ultrasound and Activator therapies. The frequency, duration and patient contact with the chiropractor will match that of the active chiropractic arm. The chiropractors will be trained to give the same enthusiasm as when delivering the chiropractic care.Four treatments will provided to each participant. The initial consultation will include a detailed medical history assessment and will last for about one hour. The three subsequent treatments, spaced at weekly intervals, will last for about 20-30 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 290796 0
Pain intensity, assessed on a 11-point numerical rating scale
Timepoint [1] 290796 0
1 week; 2 weeks; and 4 weeks
Secondary outcome [1] 305302 0
global perceived change, assessed on a 11-point scale
Timepoint [1] 305302 0
1 week; 2 weeks; and 4 weeks
Secondary outcome [2] 305303 0
treatment satisfaction, assessed on a 5-point scale
Timepoint [2] 305303 0
4 weeks
Secondary outcome [3] 305329 0
Disability, assessed by the Roland-Morris Disability Questionnaire
Timepoint [3] 305329 0
1 week; 2 weeks; and 4 weeks
Secondary outcome [4] 305330 0
Blinding, assessed by the Bang Index
Timepoint [4] 305330 0
4 weeks

Eligibility
Key inclusion criteria
Young people will be eligible to participate in the pilot study if they meet the following criteria: aged between 13 and 17 years (inclusive) who have experienced non-specific low back pain once a week for at least 6 weeks; and have a NRS for low back pain of 3 out of 10 on the day that baseline measures are collected
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Young people will be excluded if they meet any of the following exclusion criteria: known pathology causing their low back pain (for example, fracture, spinal infection, neoplastic disorders); clinical signs and symptoms of a lumbar disc herniation; a history of spinal surgery; not fluent and/or literate in the English language; currently receiving care for low-back pain from any other healthcare provider; unable to consent to treatment. Young people will also be excluded if they have previously received manipulation, as previous experience of manipulation may affect successfully maintaining blinding. If eligible informed consent will be obtained.

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)
Allocation will occur directly after baseline measures are undertaken. A statistician will generate the randomisation sequence and then place the allocation (A or B) in sequentially numbered, opaque, sealed envelopes and distribute them to the participating chiropractors. As each participant enters the trial the next consecutive opaque, sealed envelope will be opened to allocate the participant to chiropractic care or sham.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
28/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288192 0
Charities/Societies/Foundations
Name [1] 288192 0
Chiropractic and Osteopathic College of Australasia Research Pty Ltd
Country [1] 288192 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South ST, Murdoch, WA, 6150
Country
Australia
Secondary sponsor category [1] 286916 0
None
Name [1] 286916 0
Address [1] 286916 0
Country [1] 286916 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290101 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 290101 0
90 South ST, Murdoch, WA, 6150
Ethics committee country [1] 290101 0
Australia
Date submitted for ethics approval [1] 290101 0
22/11/2013
Approval date [1] 290101 0
Ethics approval number [1] 290101 0

Summary
Brief summary
Health in early life has a profound impact on health and quality of life in later years. Up to 75% of adolescents have experienced back pain with children and adolescents more likely to have recurrent pain in adulthood that may develop into disabling psychological distress and illness behaviour.

Chiropractors treat adolescents with low back pain primarily using various forms of spinal manipulation. However, there is no high quality evidence to support or refute the effectiveness of chiropractic, or other manual approaches, for back pain in adolescents. There is also no agreement on what is thought to be the “best” approach for chiropractors to care for adolescents with non-specific low back pain. Hence, we undertook a Delphi study to construct a best chiropractic practice guideline for adolescent low back pain which we intend to administer in a randomised controlled trial. The objectives of this study are to: examine the feasibility of implementing a protocol of best practice chiropractic care for adolescents with non-specific low back pain; and undertake a pilot study of a randomised trial of chiropractic care for non-specific low-back pain in adolescents to examine the feasibility of conducting a fully powered randomised trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43982 0
A/Prof Bruce Walker
Address 43982 0
School of Health Professions, Murdoch University, 90 South ST Murdoch, WA, 6150
Country 43982 0
Australia
Phone 43982 0
+61 8 9360 1297
Fax 43982 0
Email 43982 0
[email protected]
Contact person for public queries
Name 43983 0
A/Prof Bruce Walker
Address 43983 0
School of Health Professions, Murdoch University, 90 South ST Murdoch, WA, 6150
Country 43983 0
Australia
Phone 43983 0
+61 8 9360 1297
Fax 43983 0
Email 43983 0
[email protected]
Contact person for scientific queries
Name 43984 0
A/Prof Bruce Walker
Address 43984 0
School of Health professions, Murdoch University, 90 South ST Murdoch, WA, 6150
Country 43984 0
Australia
Phone 43984 0
+61 8 9360 1297
Fax 43984 0
Email 43984 0
[email protected]

No information has been provided regarding IPD availability


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
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