None listed
Conditions
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.
Interventions
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. Th
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.
Sponsors
Murdoch University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed