Managing Injuries of the Neck Trial (MINT) Simon Gates

Transcription

1 Managing Injuries of the Neck Trial (MINT) Simon Gates

2 Contents Background Study design Results Conclusions

3 The MINT team Sallie Lamb Simon Gates Mark Williams Esther Williamson Emma Withers Martin Underwood Matthew Cooke Deborah Ashby Shahrul Mt Isa Emanuela Castelnuovo and many others

4 BACKGROUND

5 The problem Whiplash injuries are a major cause of ED attendance Cost UK economy 3.1 billion per year (2002) health service costs and loss of work 30%-50% of patients have chronic symptoms Uncertainty about best treatment

6 HTA Commissioned Project 2003 What is the effectiveness and cost effectiveness of active treatment for whiplash? HTA brief Interventions should be education and advice plus active, nonsurgical, non-pharmacological interventions for whiplash. Include patients with acute Whiplash Injuries Use a Randomised controlled trial design Use the outcomes: Pain, disability, return to work, quality of life and cost Analyse the effect of pre-specified subgroups Have a minimum follow-up of 12 months

7 Terminology Whiplash: mechanism of injury acceleration / deceleration usually in the frontal plane Whiplash associated disorders (Spitzer 1995) WAD Grade O WAD Grade I WAD Grade II WAD Grade III WAD Grade IV Late Whiplash Syndrome No signs or symptoms Complaint of pain, stiffness or tenderness Complaint of pain, stiffness or tenderness Complaint of pain, stiffness or tenderness Fracture or dislocation Symptoms sufficient to hinder normal activity No physical signs Musculoskeletal signs + Neurological signs > 6 months

8 STUDY DESIGN

9 Design Two linked RCTs evaluating stepped care approach Early advice given at ED attendance (cluster randomised, NHS Trusts) Physiotherapy treatment for patients with persistent problems (individually randomised) Economic evaluation Qualitative and methodological studies

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11 Step 1: Eligibility Acute whiplash injury WAD Grade I-III Exclusions < 18 years more than a transient loss of consciousness Glasgow Coma Score 12 Fracture/dislocation requiring admission or severe psychiatric illness

12 Step 1: Interventions Active management advice Training to promote active management Patient education booklet (The Whiplash Book) Usual care Usual advice for patients with whiplash injuries Collected usual advice materials from participating hospitals

13 Step 2: Eligibility Informed trial if ongoing symptoms Assessed and randomised at research clinic active symptoms in the previous 24 h WAD grade I III No contra-indications to physiotherapy

14 Step 2: Physiotherapy intervention Evidence about risk factors and effective treatments Existing physiotherapy practice and guidelines Deliverability Manual therapy Exercise Psychological strategies and self-management advice. Consistent with CSP guideline Up to 6 sessions over a 6 week period + assessment session

15 Step 2: control intervention 40 min session with a physiotherapist No hands on Reinforcement of ED advice Questions and Answers

16 Outcomes (Steps 1 & 2) Follow-up (postal) at 4, 8 and 12 months post injury Disease specific measure - Neck Disability Index Generic Health Related Quality of Life (SF12) Health economics (health care costs NHS, individual, third party; work; out of pocket expenses; Insurance payouts)

17 RESULTS

18 Recruitment Nov 2005 to Dec NHS Trusts (15 EDs) Step 1: 3851 patients recruited Step 2: 599 patients recruited Follow up at 12 months: Step 1 70% Step 2 80%

19 Results: Step 1 Primary Outcome - NDI Neck Disability Index (%) UCA WBA 4m follow up 8m follow up 12m follow up Points are offset for visual purposes only

20 Results: Step 1 Secondary Outcome SF SF-12v1 MCS SF-12v1 PCS UCA WBA Baseline 4m follow up 8m follow up 12m follow up Points are offset for visual purposes only 35 UCA WBA Baseline 4m follow up 8m follow up 12m follow up Points are offset for visual purposes only

21 Results: Step 2 Primary Outcome - NDI Difference in NDI 95% CI 4 months -3.7 (-6.1, -1.3) 8 months -1.0 (-3.6, 1.6) 12 months -2.0 (-4.6, 0.6)

22 Results: Step 2 Secondary Outcome SF SF-12v1 MCS SF-12v1 PCS Advice Physio Baseline 4m follow up 8m follow up 12m follow up Points are offset for visual purposes only 35 Advice Physio Baseline 4m follow up 8m follow up 12m follow up Points are offset for visual purposes only

23 CONCLUSIONS

24 Conclusions Psycho-educational advice package delivered in ED was no more effective than usual care Multi-modal physiotherapy package results in short term benefit, but no difference in longer term outcomes Neither active management advice nor physiotherapy was cost-effective