| OBJECTIVES: Neck pain is a common and bothersome complaint that is frequently presented to the general practitioner (GP). In a recent RCT by our group, manual therapy was found to be more effective than physiotherapy and continued care by the GP for sub-acute and chronic neck pain. The current study aims to compare the effects of a cognitive behavioural graded activity (CBGA) programme with manual therapy for sub-acute non-specific neck pain on recovery of the neck pain and the prevention of chronicity. METHODS: 180 patients with sub-acute neck pain (one to three months duration of the current episode) will be recruited by GPs and randomly allocated to either 6 weeks of manual therapy or 12 weeks of CBGA therapy. The cognitive component of CBGA includes assessment of the adequacy of cognitions and beliefs, reassuring the patient that it is safe to exercise, teaching the patient how to cope with the pain, and promoting self-management of the pain. The behavioural component of CBGA is integrated in a graded activity programme with the following key features: baseline measurements to tailor the start of the programme to each patient's individual capacities, functional exercises with a time-contingent increase in intensity, positive reinforcement to stimulate the patient, and coaching from the therapist. The manual therapy consists of a range of manual therapeutic interventions, including muscular mobilization techniques, specific articular mobilization techniques, and co-ordination or stabilization exercises. The primary outcome measures are perceived recovery, patient-specific main complaint and the Neck Disability Index Score. Secondary outcome measures consist of measurement of pain and quality of life and a number of intermediate, psychological variables such as fear-avoidance beliefs, kinesiophobia, pain catastrophizing and coping skills, and measurement of psychological distress. Effects will be measured after 6, 12, 26 and 52 weeks. Sub-group analysis will be performed on the basis of patient characteristics to investigate what treatment works best for whom. The influence of patient and GP preferences and the attitudes of the therapists on the effects of the treatment will also be examined. Cost diaries will provide relevant data for cost-effectiveness analysis. Furthermore, in a prognostic study, potential predictors for developing chronic complaints will be investigated to obtain insight into prevention of chronicity. |