None listed
Conditions
Brief summary
Acute whiplash is a heterogeneous disorder that becomes persistent in 40-60% of cases. Estimates of recovery have not changed in recent decades. This randomized, single blind, controlled trial tested whether multidisciplinary individualized treatments for patients with acute whiplash (<4 weeks post-injury) could reduce the incidence of chronicity at 6-months by 50% compared to usual care. Participants (n=101) were recruited from accident and emergency centres and the community. It was hypothesized that better recovery rates were achievable if the heterogeneity was recognised and patients received individualised interventions. Patients randomized to pragmatic intervention (n=49) could receive pharmaceutical management (ranging from simple to opioid analgesia), multimodal physiotherapy and psychology for post-traumatic stress based on their presentations. The treatment period was 10-weeks with follow-up at 11-weeks, 6 and 12-months. The primary outcome was neck pain and disability (Neck Disability Index (NDI)). Analysis revealed no significant differences in frequency of recovery (NDI=8%) between the pragmatic and usual care groups at 6 and 12 month follow-up (LR chi-sq=1.94, p=0.16 and LR chi-sq=1.09, p=0.30 respectively). There was no improvement in current non-recovery rates at 6 months (63.6% - pragmatic care; 48.8% - usual care), indicating no advantage of the early multi-professional intervention. Baseline levels of pain and disability had a significant bearing on recovery both at 6 and 12 months in both groups, suggesting that future research focus on finding early effective pain management particularly for the sub-group of patients with initial high levels of pain and disability towards improving recovery rates.
Interventions
The study is a RCT with unblinded treatment and blinded outcome assessment in patients with acute whiplash disorders, classified as WAD II, to test the effectiveness of a pragmatic multi-professional management approach (medical, physiotherapy and psychological management) to reduce the incidence of chronicity. Within the randomization process, subjects will be stratified on three factors predictive of a poor prognosis (high NDI score; signs of moderate post-traumatic distress reaction; abnorm
The study is a RCT with unblinded treatment and blinded outcome assessment in patients with acute whiplash disorders, classified as WAD II, to test the effectiveness of a pragmatic multi-professional management approach (medical, physiotherapy and psychological management) to reduce the incidence of chronicity. Within the randomization process, subjects will be stratified on three factors predictive of a poor prognosis (high NDI score; signs of moderate post-traumatic distress reaction; abnormal sensory responses {at least two of cold hyperalgesia, pressure hyperalgesia, impaired sympathetic vasoconstriction}) to ensure equal distribution of these factors between the pragmatic intervention and usual care groups. The pragmatic management approach will be tested against a control intervention of usual care. The medical, physiotherapy and psychological management within the pragmatic approach will be prescribed in accordance with the subjects level of pain and presenting physical and psychological features. The intervention period and the number of medical, physiotherapy and/or psychological consultations will be variable and as required for the individual subject depending on the severity of their condition, but will be for a maximum of 10 weeks. Full recovery can be expected for at least 40% of whiplash patients within 12-24 weeks post-injury with usual care. Outcomes will be tested after the 10 week intervention period (week 11) regardless of the length of treatment time, and at 6 months and 12 months post-injury. The direct costs of this approach and of usual care will be measured and the costs associated with lost earnings and time in treatment will be calculated until 12 months post-injury. The treatment costs will be those incurred during the intervention period as well as any further treatment costs incurred in the 12 months post-injury. In addition to these measures of costs, utility weights (or health state preferences) will be measured using the standard gamble (SG), time-trade-off (TTO) and visual analogue scale (VAS) approaches.
Sponsors
Professor Gwendolen Jull
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Volunteers suffering from acute neck pain and disability resulting from a motor vehicle crash and classifiable as WAD II, presenting within 4 weeks of injury. Evidence of cervical nociceptive and musculoskeletal impairment: restriction in active cervical motion, impairment in the cranio-cervical flexion muscle test, tenderness over the cervical joints.
Exclusion criteria
Subjects with WAD I, III or IV. Previous whiplash injury. Prior neck pain condition for which treatment has been sought from a health professional. Current medical disorder that would preclude. Lack of fluency in spoken and written English for independent questionnaire completion. Lack of willingness to receive either pragmatic treatment or usual care.
Outcome results
None listed