None listed
Conditions
Brief summary
Many chiropractors believe that X-rays are needed to detect findings that will either contraindicate or change the application of spinal manipulative therapy. Without X-rays, these chiropractors believe that they may perform sub-optimal and potentially unsafe care. Although this belief is in contrast to recommendations in clinical practice guidelines, current evidence is unavailable to confirm or refute this belief. The limited research available indicates that X-rays do not improve outcomes in patients with acute low back pain when managed with usual medical care. No studies have assessed the effect of X-rays on patient outcomes when patient management includes spinal manipulative therapy. The effect of X-ray use on areas other than the low back, or on adverse events after spinal manipulative therapy have also not been examined. A large-scale fully powered effectiveness trial will provide important information to inform chiropractic clinical practice regarding the appropriate use of X-rays for spinal pain, to maximise patient outcomes and limit potential risks. This proposed pilot randomised controlled trial aims to provide critical feasibility data prior to performing a large-scale effectiveness trial. This study will inform the ability to recruit patients and chiropractors, the willingness of chiropractors to treat patients without X-ray, and the amount of patient loss to follow-up or cross-over rates.
Interventions
The intervention is referral for spinal X-rays.
Chiropractors will be recruited into the study if they self-report to regularly refer new patients for X-rays and treat patients with spinal manipulation. The participating chiropractor will use clinician judgement as per their standard practice to determine whether a patient requires an X-ray. Patients who the practitioner determines require an X-ray but do not have any suspicion of underlying serious pathology (see inclusion criteria) will be el
The intervention is referral for spinal X-rays. Chiropractors will be recruited into the study if they self-report to regularly refer new patients for X-rays and treat patients with spinal manipulation. The participating chiropractor will use clinician judgement as per their standard practice to determine whether a patient requires an X-ray. Patients who the practitioner determines require an X-ray but do not have any suspicion of underlying serious pathology (see inclusion criteria) will be eligible for participation in the study, and for randomisation if they consent to participate. Participants allocated to the intervention group will receive an X-ray of the relevant spinal region/s (as determined by the treating chiropractor). X-rays will be taken either onsite (if available) or at an external radiology clinic. If a participant chooses not to have the X-ray, they do not need to do so and this will be recorded as a cross-over between groups. Any further treatment will be provided as determined by the treating chiropractor. Follow-up surveys to both the patient at 2, 6, and 12 weeks will be used to determine if x-rays were taken as allocated at randomisation.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria for patients: • New episode of spinal pain, defined as no prior episode with greater than or equal to 2/10 numerical pain score lasting more than 24 hours within the previous month • Treating chiropractor intending to refer the patient for X-ray, for reasons outside current X-ray guidelines. • Treating chiropractor intending to use spinal manipulative therapy as a treatment option • Ability to read and understand English to consent to the research and complete the questionnaires. Inclusion criteria for chiropractors: • Chiropractors who self-report regularly treating patients presenting with spinal pain • Chiropractors who self-report that they use spinal manipulative therapy with the majority of their spinal pain patients • Chiropractors who self-report regularly (but not always) referring patients for X-rays (referring between 20-80% of new patients for X-ray) • Willing to randomise patients to be X-rayed • Practice within Sydney or immediate surrounds.
Exclusion criteria
• Under 18 years of age • Pregnancy • Treating chiropractor suspects serious underlying pathology requiring further investigation or referral (e.g. cancer, infection, fracture, cauda equina syndrome, myelopathy, progressive neurological symptoms, chest or abdominal pathology)
Outcome results
None listed