Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000542998
Ethics application status
Not yet submitted
Date submitted
2/05/2011
Date registered
25/05/2011
Date last updated
25/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the effectiveness of chiropractic care for spinal pain and measuring any side effects from that care.
Scientific title
A randomised sham-controlled trial examining the efficacy of short term usual chiropractic care for non-specific spinal pain and associated adverse events
Secondary ID [1] 259949 0
Nil
Universal Trial Number (UTN)
Trial acronym
OUCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific spinal pain of at least one week duration. Spinal pain refers to pain that may be associated with either the cervical, thoracic, or lumbar regions of the spine. 265573 0
Condition category
Condition code
Musculoskeletal 265717 265717 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Usual Chiropractic Care: a series of two chiropractic treatments to the spine as deemed suitable by a registered chiropractor. Treatments include one or more of the following: spinal manipulation, mobilisation, drop piece, traction, electro- therapies, ultrasound, soft tissue techniques and other manual techniques offered by the chiropractor. Each treatment will be between 10-15 minutes in duration, and the interval between the first and second treatment must be between one week to two weeks. This treatment approach replicates a common pragmatic approach in the field.
Intervention code [1] 264360 0
Treatment: Other
Comparator / control treatment
Sham Group: participants will receive two sessions of de-tuned ultrasound and random spinal de-tuned activator treatment by a chiropractor to the regions where spinal pain is experienced. There is no known treatment benefit from the detuned ultrasound machine; however, it has been established in previous trials as a credible treatment option by patients. For the de-tuned activator we will ensure that the amount of pressure exerted by it is no more than the head of the ultrasound transducer. To achieve this we will wind the activator head force to minimum and then administer the force through a wooden tongue depressor at random locations in the spine near the areas of concern. The dimensions of the depressor are 19 mm wide and 150 mm long, although on average only 600 mm of the length will be in contact with the skin. This means a surface area of 1140 mm2. We measured the force this will provide to the skin using a force transducer. The mean of 5 measured attempts was 3.7 kPa. To increase the perceived “hands on” credibility, the chiropractor will be trained to gently place one hand on the area adjacent to the participant’s spine while delivering the ultrasound and Activator therapies.
Control group
Placebo

Outcomes
Primary outcome [1] 266481 0
Adverse event (yes/no).
Examples of common adverse which occur during chiropractic include: muscle stiffness, increased pain, referred numbness and tingling, and headache.
Timepoint [1] 266481 0
Two days after each of the two treatment sessions.
Secondary outcome [1] 273860 0
Pain, assessed with the Numerical Rating Scale.
Timepoint [1] 273860 0
Two week follow-up
Secondary outcome [2] 273861 0
Physical function, assessed with the Functional Rating Index and one of either the Neck Disability Index, Oswestry Disability Index or Modified Oswestry Disability Index.
Timepoint [2] 273861 0
Two week follow-up.
Secondary outcome [3] 273862 0
Minimum Acceptable Outcome. At baseline, the participants will be asked to indicate on a Numerical Rating Scale the minimum level of reduction in pain they would need to experience at the conclusion of trial in order for them to consider it to be an acceptable outcome. Whether the participants' experienced a minimum acceptable outcome will be determined by comparing the baseline data to the scores on the Numerical Rating Scale at two week follow-up.
Timepoint [3] 273862 0
Two week follow-up.

Eligibility
Key inclusion criteria
Potential participants must be adults, literate in English, and have had spinal pain for more than 1 week. In addition, potential participants must score at least 3 on the NRS and 12 on the FRI as this allows measurement of a minimal clinically significant difference in the improvement direction.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they are unable to tolerate manipulation; mobilisation; Activator (Registered Trademark); flexion distraction therapy; traction; soft tissue massage; trigger point therapy; sacro-occipital technique; ultrasound; interferential therapy; TENS; and applied kinesiology.

Participants will also be excluded if they have any of the following conditions: spinal pain related to cancer or infection; fracture of the spine; spondyloarthropathy; known osteoporosis; progressive upper or lower limb weakness; symptoms of cauda equina syndrome or other significant neurological condition; disc herniation; cardiovascular disease; uncontrolled hypertension; cognitive impairment; blood coagulation disorder, had previous spinal surgery, or a previous history of stroke or transient ischaemic attacks; have a pacemaker or other electrical device implanted;are currently pregnant.
Finally, participants will be excluded if they have a current compensation claim, a substance abuse problem or if they could not commit to the study protocol

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)
Participants will be recruited by the use of newspaper advertisements. Any person who responds to the advertisement by phone will be considered a potential candidate and will receive through the mail the following documents: an information letter; a pain diagram to assess symptom location and distribution; the Numerical Rating Scale on which the patients will score their current overall level of spinal pain; Functional Rating Index; a questionnaire inquiring about the minimum amount of change in pain levels that potential participants would consider to be an acceptable outcome; medical history checklist. These documents will be returned in a reply paid envelope and the information will be used to determine eligibility.

One of the research staff, excluding the research assistant and statistician, will randomly allocate the participants to one of the two groups. A statistician will generate a set of block random numbers allocating persons to either chiropractic care or the sham group. The group assignment will be written on small cards wrapped in aluminum foil and placed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
14/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264831 0
Commercial sector/Industry
Name [1] 264831 0
Chiropractors Registration Board of Victoria
Country [1] 264831 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
South St
Murdoch
Western Australia 6150
Country
Australia
Secondary sponsor category [1] 264094 0
None
Name [1] 264094 0
Address [1] 264094 0
Country [1] 264094 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266975 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 266975 0
90 South Street
Murdoch WA 6150
Ethics committee country [1] 266975 0
Australia
Date submitted for ethics approval [1] 266975 0
19/05/2011
Approval date [1] 266975 0
Ethics approval number [1] 266975 0

Summary
Brief summary
Given the limitations associated with previous studies of adverse events during chiropractic care, it is evident that controlled studies are warranted to develop a better understanding of the incidence of adverse events in chiropractic care. This proposition reflects the findings of a recent systematic review that concluded there were no robust data concerning the incidence or prevalence of adverse reactions after chiropractic and recommended urgent investigations to provide definite conclusions as to its safety profile.

The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. This will add to the literature on the efficacy of short term usual chiropractic care.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 32452 0
Address 32452 0
Country 32452 0
Phone 32452 0
Fax 32452 0
Email 32452 0
Contact person for public queries
Name 15699 0
Bruce Walker
Address 15699 0
Rm 4.019 ECL
Murdoch University
90 South Street
Murdoch WA 6150
Country 15699 0
Australia
Phone 15699 0
+61 8 93601297
Fax 15699 0
Email 15699 0
bruce.walker@murdoch.edu.au
Contact person for scientific queries
Name 6627 0
Bruce Walker
Address 6627 0
Rm 4.019 ECL
Murdoch University
90 South Street
Murdoch WA 6150
Country 6627 0
Australia
Phone 6627 0
+61 8 93601297
Fax 6627 0
Email 6627 0
bruce.walker@murdoch.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseOutcomes of usual chiropractic, harm & efficacy, the ouch study: Study protocol for a randomized controlled trial.2011https://dx.doi.org/10.1186/1745-6215-12-235
N.B. These documents automatically identified may not have been verified by the study sponsor.