Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000805572
Ethics application status
Approved
Date submitted
30/06/2015
Date registered
3/08/2015
Date last updated
18/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Chiropractic for Adolescent Low back pain including Manipulation/Manual Therapy. The CALM Study.
Scientific title
Chiropractic for Adolescent Low back pain including Manipulation/Manual Therapy compared to a sham treatment for pain and disability. A randomised controlled trial pilot study. The CALM Study.
Secondary ID [1] 287002 0
Nil
Universal Trial Number (UTN)
U1111-1171-7170
Trial acronym
CALM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Low Back Pain 295469 0
Condition category
Condition code
Musculoskeletal 295723 295723 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295871 295871 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The chiropractic clinicians will deliver usual chiropractic care in the form of massage, mobilization, manipulation, and exercise prescription.

1. The patient participants will receive four consultations, of about 15-30 minutes each, of which two will be delivered in the first week, and the other two at subsequent weekly intervals.

2. The participants will receive the following interventions:

Manipulation
For the purpose of this study lumbo-pelvic manipulation is defined as a localised force of high velocity and low amplitude thrust directed at a spinal joint often resulting in joint cavitation or a cracking sound and/or

Mobilisation
For the purpose of this study lumbo-pelvic mobilisation is defined as gentle, controlled movements of the spinal joints within the normal ranges of movement and

Advice to stay active
This is general advice given to the participant to remain active and continue with normal duties within tolerance and as possible. This is as opposed to bed rest and/or

Specific back exercises
Tailored exercises provided to an individual participant by the treating chiropractor for their back pain or

General exercise
Advice to undertake general exercise such as walking or other low impact aerobic activity for 30 minutes on at least 5 days per week and

Modification of activities
Advice to modify daily activities that are likely to worsen the condition or retard recovery

3. A home exercise and other treatment diary will be administered to monitor compliance with exercises and utilization of other treatments for back pain.
Intervention code [1] 292209 0
Treatment: Other
Comparator / control treatment
Sham group : participants will receive de-tuned ultrasound (no intensity) and de-tuned Activator Trademark treatment that provides a very small impulse provided by a hand held device delivered through a tongue depressor (see: http://www.activator.com/) 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.
Control group
Placebo

Outcomes
Primary outcome [1] 295427 0
Primary outcome is pain using a visual analog scale for pain.
Timepoint [1] 295427 0
Outcomes will be measured one week, two weeks, and four weeks after chiropractic care/sham commences .
Primary outcome [2] 295428 0
Primary outcome is disability using a Roland Morris instrument for disability.
Timepoint [2] 295428 0
Outcomes will be measured one week, two weeks, and four weeks after chiropractic care/sham commences .
Primary outcome [3] 295620 0
Assessment of feasibility of conducting a larger, fully-powered, randomized controlled trial. The feasibility of the main study will be determined by assessing the following criteria during the pilot study:
1. all chiropractor clinicians recruited within two weeks
2. 20 patients recruited within four weeks of placing recruitment notices
3. 100% of recruited patients allocated to assigned group
4. 90% of patients complete baseline measures within 30 mins
5. 85% of patients receive all assigned treatments within three weeks
6. 95% of consultations adhere to treatment protocol
chiropractors ability to successfully deliver the usual and sham intervention, assessed qualitatively through brief survey instrument/telephone interviews
7. 100% of treatments deemed safe, in that reported adverse events are benign and transitory
complete follow-up in at least 90% of all recruited subjects
8. Treatment costs will be assessed

This is a composite primary outcome.
Timepoint [3] 295620 0
Outcomes will be measured one week, two weeks, and four weeks after chiropractic care/sham commences .
Secondary outcome [1] 315570 0
General Health using the SF-36
Timepoint [1] 315570 0
Outcomes will be measured at four weeks after chiropractic care/sham commences
Secondary outcome [2] 315838 0
Measures of well-being using the EQ-5D-5L.
Timepoint [2] 315838 0
Outcomes will be measured four weeks after chiropractic care/sham commences

Eligibility
Key inclusion criteria
Aged between 13 and 17 years (inclusive) who have experienced non-specific low back pain in the last month for at least 14 of those days; and have a Visual Analogue Scale for low back pain of at least 3 out of 10 in the previous 24 hours.
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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, or are 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.

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)
A registered chiropractor will administer the inclusion and exclusion criteria by way of questionnaire and examination. Suitable participants will be provided information about the study and then offer a consent form. Parents will also provide consent. If admitted to the study, participants will be randomised using block randomisation sequence and a set of numbers sealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician will generate the block randomisation sequence and then place the allocation (A or B). The sequence will be allocated by a phone call to a blinded Research Assistant who holds the envelopes; this will allow each participant to enter the trial into either the chiropractic care or sham group in a random manner.
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
This is a feasibility study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will analyze feasibility and not effect sizes in this pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/08/2015
Actual
2/11/2015
Date of last participant enrolment
Anticipated
15/10/2015
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291554 0
University
Name [1] 291554 0
Murdoch University
Country [1] 291554 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch
6150 WA
Country
Australia
Secondary sponsor category [1] 290231 0
None
Name [1] 290231 0
Address [1] 290231 0
Country [1] 290231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293096 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 293096 0
Ethics committee country [1] 293096 0
Australia
Date submitted for ethics approval [1] 293096 0
24/07/2015
Approval date [1] 293096 0
28/09/2015
Ethics approval number [1] 293096 0
Human Ethics Permit 2015/216.

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

Contacts
Principal investigator
Name 58462 0
A/Prof Bruce Walker
Address 58462 0
Room 1.011 Building 461
90 South St
Murdoch University, Murdoch 6150 WA
Country 58462 0
Australia
Phone 58462 0
61893601297
Fax 58462 0
Email 58462 0
[email protected]
Contact person for public queries
Name 58463 0
Bruce Walker
Address 58463 0
Room 1.011 Building 461
90 South St
Murdoch University, Murdoch 6150 WA
Country 58463 0
Australia
Phone 58463 0
61893601297
Fax 58463 0
Email 58463 0
[email protected]
Contact person for scientific queries
Name 58464 0
Bruce Walker
Address 58464 0
Room 1.011 Building 461
90 South St
Murdoch University, Murdoch 6150 WA
Country 58464 0
Australia
Phone 58464 0
61893601297
Fax 58464 0
Email 58464 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

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