Detailed Search Results
| Author/Association: | Lamb SE, Gates S, Williams MA, Williamson EM, mt-Isa S, Withers EJ, Castelnuovo E, Smith J, Ashby D, Cooke MW, Petrou S, Underwood MR, Managing Injuries of the Neck Trial (MINT) Study Team |
| Title: | Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial [with consumer summary] |
| Source: | Lancet 2013 Feb 16;381(9866):546-556 |
| Method: | clinical trial |
| Method Score: | 7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
| Consumer Summary: | RESEARCH IN CONTEXT: SYSTEMATIC REVIEW: We searched PubMed and the Cochrane Library for systematic reviews and randomised controlled trials investigating conservative treatments for acute whiplash injuries. We used a combination of text terms and medical subject headings, search dates were January, 1966, to April, 2012, and recognised quality assessment criteria. We identified three systematic reviews, encompassing 17 trials of acute whiplash associated disorder of grade 0 to III and one additional randomised trial of a nurse home visit at 10 days after injury. The quality of the reviews was high but the quality of trials within the reviews was mostly low. Overall, recent reviews conclude health education pamphlets are not effective, and that physiotherapy with exercise and manual therapy might be eff ective for short-term outcomes. We found very few good quality trials with long-term follow-up. INTERPRETATION: Emergency departments should continue to provide usual care for whiplash injuries. More enhanced forms of advice, in the form of specially trained nurses, pamphlets, or, as we tested, an active management consultation with the Whiplash Book, provide no additional benefit. Our trial confirms physiotherapy packages that include exercise and manual therapy are effective in accelerating recovery of function, reducing pain in the short term, and reduce work absence. We report no eff ect on longer term recovery (6 to 12 months), although this is at odds with a pre-existing study.30 The benefit of a package of physiotherapy is modest by comparison with provision of a single advisory session with the physiotherapist, and, accounting for other sources of provision, is not cost effective from an NHS perspective. Usual consultations in emergency departments and a single follow-up physiotherapy advice session for persisting symptoms are recommended. |
| Abstract: | BACKGROUND: Little is known about the effectiveness of treatments for acute whiplash injury. We aimed to estimate whether training of staff in emergency departments to provide active management consultations was more effective than usual consultations (step 1) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms (step 2). METHODS: Step 1 was a pragmatic, cluster randomised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grades I to III. The hospitals were randomised by clusters to either active management or usual care consultations. In step 2, we used a nested individually randomised trial. Patients were randomly assigned to receive either a package of up to six physiotherapy sessions or a single advice session. Randomisation in step 2 was stratified by centre. Investigator-masked outcomes were obtained at 4, 8, and 12 months. Masking of clinicians and patients was not possible in all steps of the trial. The primary outcome was the Neck Disability Index (NDI). Analysis was intention to treat, and included an economic evaluation. The study is registered ISRCTN33302125. FINDINGS: Recruitment ran from Dec 5, 2005 to Nov 30, 2007. Follow-up was completed on Dec 19, 2008. In step 1, 12 NHS Trusts were randomised, and 3,851 of 6,952 eligible patients agreed to participate (1,598 patients were assigned to usual care and 2,253 patients were assigned to active management). 2,704 (70%) of 3,851 patients provided data at 12 months. NDI score did not differ between active management and usual care consultations (difference at 12 months 0.5, 95% CI -1.5 to 2.5). In step 2, 599 patients were randomly assigned to receive either advice (299 patients) or a physiotherapy package (300 patients). 479 (80%) patients provided data at 12 months. The physiotherapy package at 4 months showed a modest benefit compared to advice (NDI difference -3.7, -6.1 to -1.3), but not at 8 or 12 months. Active management consultations and the physiotherapy package were more expensive than usual care and single advice session. No treatment-related serious adverse events or deaths were noted. INTERPRETATION: Provision of active management consultation did not show additional benefit. A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective. Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended. FUNDING: NIHR Health Technology Assessment programme. Full text (sometimes free) may be available at these link(s):  help |
