Wiangkham T.1,2, Duda J.3, Haque S.4, Price J.5, Rushton A.1
1University of Birmingham, Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, Birmingham, United Kingdom, 2Naresuan University, Department of Physical Therapy, Faculty of Allied Health Sciences, Phitsanulok, Thailand, 3University of Birmingham, School of Sport, Exercise and Rehabilitation Sciences, Birmingham, United Kingdom, 4University of Birmingham, Institute of Clinical Sciences, Birmingham, United Kingdom, 5Birmingham Community Healthcare NHS Foundation Trust, Birmingham, United Kingdom
Background: Up to 60% of patients progress to chronicity following whiplash injury. Research therefore needs to focus on effective management in the acute stage to prevent chronicity. Approximately 93% of patients are classified as WADII [neck complaint and musculoskeletal sign(s)] and in the UK most are managed in the private sector. Our rigorous systematic review identified that a combined Active Behavioural Physiotherapy Intervention (ABPI) was potentially effective in the acute stage. An ABPI was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory - self-efficacy enhancement) evidence.
Purpose: To evaluate procedures and feasibility of the ABPI for managing acute WADII within the UK insurance private sector, to inform design and sample size requirements for a future adequately powered definitive trial.
Methods: An external pilot and feasibility cluster-randomised double-blind (assessor, participants) parallel two-arm (ABPI versus standard physiotherapy) clinical trial. Six UK private physiotherapy clinics were recruited and cluster-randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) were targeted to assess at baseline and 3-month follow-up. The planned primary outcome measure was the Neck Disability Index. Visual Analogue Scale (VAS) pain intensity, Cervical Range of Motion (CROM), Pressure Pain Threshold (PPT) bilaterally on levator scapulae and tibialis anterior muscles, Impact of Events Scale (IES), and Fear-Avoidance Beliefs Questionnaire (FABQ) were planned secondary outcome measures. Data were analysed descriptively. The trial protocol was registered (ISRCTN84528320) and published in BMJ Open (2016).
Results: 28 participants [median age 38.00(IQR=21.50) years] (20 ABPI arm, 8 standard physiotherapy arm) were recruited. The target sample size was not achieved owing to the unexpected liquidation of the private physiotherapy company central to the trial. At 3 months, losses to follow up were 0% in ABPI arm and 25% in the standard physiotherapy arm. Participants in both arms demonstrated improvement in all outcome measures. Comparison of the median of difference between interventions at 3 months, demonstrated better results for the ABPI for: NDI [ABPI median 16.50(IQR 17.25): standard physiotherapy 6.50(12.50)]; VAS [48.50(37.25):37.00(49.75)]; EQ-5D [5.50(4.75):2.00(3.00)]; CROM flexion [-27.67(14.00):-17.34(21.01)], extension [-21.17(23.59):-14.83(35.33)], L.rotation [-22.00(28.42):1.00(26.00)], R.rotation [-32.00(26.91):-4.34(12.00)], L.lateral flexion [-11.50(16.58):1.17(13.25)], R.lateral flexion [-11.17(15.50):-6.67(8.08)]; and PPT L.levator scapulae [-90.33(110.99):-63.67(79.67)], R.levator scapulae [-121.50(118.33):-49.67(83.09)], R.tibialis anterior [-101.01(105.00):-86.00(160.58)]. However better results were demonstrated for standard physiotherapy for: IES [13.50(22.00):24.00(36.50)]; FABQ [9.50(33.00):22.00(31.00)]; and PPT L.tibialis anterior [-49.84(129.75):-72.67(192.42)]. 19/20 (95%) participants in the ABPI arm and 1/6 (~17%) participant in the standard physiotherapy arm completely recovered (NDI≤4). All procedures and calculated sample size were feasible for conducting a future trial. The collection of data for cost-effectiveness in the main trial can be improved as a patient diary was not useful.
Conclusion(s): Findings suggest that the ABPI may be a potential effective intervention for the management of acute WADII. Remarkably, this trial demonstrated a very high percentage of the participants who received the ABPI were fully recovered. It is feasible and valuable to conduct a definitive trial.
Implications: An adequate powered definitive randomised controlled trial is required to evaluate the effectiveness of the ABPI in managing patients with acute WADII to prevent the development of chronicity.
Funding acknowledgements: The first author (TW) thanks the Royal Thai Government and Naresuan University for the scholarship to support his PhD work.
Topic: Musculoskeletal: spine
Ethics approval: The trial protocol was approved by the University of Birmingham Ethics Committee (ERN_15-0542).
All authors, affiliations and abstracts have been published as submitted.
