National Physiotherapy Research Network • Midlands Hub • July 8th 2009
Midlands NPRN Contacts • Esther Williamson – Warwick University • firstname.lastname@example.org • Sue Kelly – Birmingham University • email@example.com • Chris Carpenter – Coventry University • firstname.lastname@example.org • NikkyClague – Leicester University • email@example.com
Managing Injuries of Neck Trial • (MINT) • Results
Background • Identified as a priority and commissioned through the NIHR HTA in 2003 • Research question: • “What is the effectiveness and cost effectiveness of active treatment for whiplash?”
Acute WAD • Quebec Task Force 1995 • McClune et al 2002; Verhagen et al 2004 • Hurwitz et al 2008 – Bone and Joint Decade 2000-2010 Task Force on Neck Pain • Since 1980; 15 reports of non-invasive interventions 2 of invasive interventions
Acute whiplash BJD Task Force “Despite an explosion of the neck-pain literature including several methodologically sound studies in the past decade, there remains limited or conflicting evidence for most of the therapies commonly given to WAD patients” 15 studies compared to usual care, placebo, sham - 7 equivalent or worse - 8 better
Trial Management Team Prof S Lamb – Clinical Trials/Physiotherapy Dr Simon Gates – Senior Research Fellow Mark Williams – Clinical Trial co-ordinator Esther Williamson - Research Fellow Emma Withers – Trial Co-ordinator Prof M Underwood – Musculoskeletal Prof M Cooke – ED Prof D Ashby - Statistician Shahrul Mt Isa - Statistician Dr S Joseph – Psychologist/Trauma EmanuelaCastelnuovo - Health Economics
Aims of MINT • To estimate the clinical effectiveness of a stepped care approach over a 12 month period after an acute injury. • To estimate the costs of each strategy including treatment and subsequent health care costs over a period of 12 months and to estimate cost effectiveness.
Study Design Stage 1: Emergency Department Treatment: Psycho educational booklet (Whiplash Book) versus Usual ED Advice Stage 2: Physiotherapy Management: Specially designed early intervention by a physiotherapist Versus Advice session only
Outcomes • Followed up at 4, 8 and 12 months post injury • Postal questionnaire: • 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) • Qualitative study – interviews of purposive sample 20 pts
Eligibility • Sustained a whiplash injury within the last 6 weeks • WAD Grade I – III with neck symptoms • Over 18 years old • No fractures/dislocations of the spine or other bones. • No head injuries with more than a transient loss of consciousness or GSC ≤ 12 at any stage. • Not admitted • No severe psychiatric illness
Stage 1: ED training • Usual Care Advice ED staff received training primarily about referring patients to trial • In contrast to • Whiplash Book Advice ED staff received more extensive training to promote key messages
The Whiplash Book • Positive messages about prognosis, promoting the message that pain is nothing to worry about. • Promotes early return to normal activities and work. • Make recommendations about physical activity, exercise and self-management of symptoms. • Advice against using a collar • Does not include information on pursuing claims or sponsorship from solicitors.
Trial progress • Developed trial materials November 2004 • Pilot study completed August 2005 • Launched main trial December 2005 • Recruitment completed October 2007 • Follow up completed December 2008
24 22 20 18 Neck Disability Index (%) 16 14 12 UCA WBA 10 4m follow up 8m follow up 12m follow up Points are offset for visual purposes only Results – Stage 1Primary Outcome - NDI
Results – stage 1 Qualitative Study • From the accounts given, participants received the same verbal advice at both WB and UC centres. • Those who received the Whiplash Book were more likely to have started doing the exercises on their own. • However, some participants in both groups expressed hesitation about doing exercises without further guidance or reassurance due to worry of doing damage or the wrong thing. • Participants appeared to mainly focus on the exercises suggesting that those receiving the WB did not utilise the other information contained in it.
Stage 1 - Conclusions • The Whiplash Book delivered in an ED setting was no more effective than the usual care that is delivered. • No change of practice but is this enough???
Stage 2: Physiotherapy • Inclusion criteria: • Still experiencing symptoms approximately three weeks after attendance at the ED • Had symptoms in the last 24 hours • WAD grade I-III at this time • Did not have any contra-indications to physiotherapy: central cord compression or upper motor neuron lesion, complete nerve root compression or lower motor neuron lesion, suspected vascular injury or haemorrhagic event.
Physiotherapy package • An assessment • Up to 6 treatment sessions • Designed to be delivered over approximately 8 week period
Development of physiotherapyintervention Patient group: Whiplash associated disorders I-III Phase of recovery: Sub-acute – referred for treatment between 3 and 6 weeks post injury Risk factors for poor outcome following a whiplash injury Current physiotherapy practice Intervention design considerations Acceptable to clinicians Current evidence base: effective treatments Standardised and reproducible to allow evaluation Existing clinical practice guidelines The setting: deliverable in the NHS
Theoretical basis for physiotherapy intervention • Risk Factor Modification • “ Variable with significant association with a clinical outcome” • Identify risk factors • Target treatments to modify these factors
Physical risk factors • High initial pain and disability • The literature also suggested that addressing reduced ROM, altered muscle function and control may be beneficial.
Psychological risk factors • Low self-efficacy • Post traumatic stress reaction • The literature also suggested that addressing fear avoidance, catastrophising, coping and distress may also be beneficial.
Physiotherapy package • Integrated approach to the management of both physical and psychological factors utilising three main components: • manual therapy • exercise • psychological strategies and self-management advice.
Control Intervention • 40 min session • No hands on • Reinforcement of ED advice • Questions and Answers
Treatments deliveredNumbers of treatment • Physiotherapy Package • Range = 0 to 23 (Median = 3.0, IQR = 1.0 -5.0) • 14 (4.7%) patients receiving greater than the recommended six treatment sessions.
Timings of treatment: • Physiotherapy package: • 63% of patients were seen within 2 weeks of referral. • 91% were seen within 4 weeks of referral • 62% of patients completed their treatment in the recommended eight weeks • 87% of patients completed within 12 weeks
Timings of treatment: • Advice session: • 53% of those receiving the advice session were seen within 2 weeks of referral. • 86% attended within 4 weeks
Results – stage 2 Characteristics • More Females (64%) • Mean age 40 yrs • WAD grades: I = 46% • II = 49% • III = 4%
Results – Step 2 • Physiotherapy intervention provided a greater reduction in NDI scores (by about 3% points) at 4 month follow up. • The difference was not retained at 8 and 12 month follow-ups. • This symptomatic relief may be very important to the individual but was not demonstrated to be cost-effective at a health service level.
Qualitative study – stage 2 • Participants receiving the Physiotherapy Package highlighted the helpfulness of the guidance and reassurance received, particularly in relation to undertaking exercises, and the manual therapy. • A minority of those receiving the physiotherapy package felt they needed more treatment.
Qualitative study – stage 2 • The advice session also provided guidance and reassurance that enabled participants to manage their injury and in particular undertake the exercises suggested in the written advice. • This single session was sufficient for many participants especially when access was relatively quick, although, some participants felt they would have benefited from a follow up session
Overall conclusions • A physiotherapy package based on manual therapy, exercise and psychological strategies and self-management advice results in short term benefit, but no difference in longer term outcomes. • At the population level there is residual disability at 12 months, this needs more careful exploration.
Non-invasive Interventions for Whiplash-Associated Disorders Likelihood of Being Helpful in the Short Term: The Bone and Joint Decade 2000 –2010 Task Force on Neck Pain and Its Associated Disorders