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The second was to confirm eligibility and general practitioners' consent, seek participants' consent, collect baseline data, and randomise participants.To exclude patients whose back pain resolved rapidly, randomisation occurred at least four weeks after the initiating consultation.12 Like other evidence based guidelines,13 the UK national acute back pain guidelines advise continuing normal activities and avoiding rest.2 To maximise recruitment and base the comparator treatment on these guidelines,11 we invited clinical and support staff from all participating practices to training sessions on the “active management” of back pain.8 We also provided copies of —We developed the exercise programme (“back to fitness”9) from previous trials.15 16 It comprises initial individual assessment followed by group classes incorporating cognitive behavioural principles. We invited participants to attend up to eight 60 minute sessions over four to eight weeks and a “refresher” class 12 weeks after randomisation.In the feasibility study participants were allocated between the six groups in equal proportions.
Participants completed questionnaires on general health, back pain, beliefs, and psychological wellbeing before randomisation and at one, three, and 12 months thereafter.Statistically this is a three by two factorial design.11 We selected 14 centres, including two for the feasibility study.All centres had general practices from the Medical Research Council (MRC) General Practice Research Framework (ukq), with a total of at least 40 000 registered patients within travelling distance of treatment locations for manipulation and exercise; two manipulators (chiropractors, osteopaths, or physiotherapists) with private premises, willing to work in NHS premises, with colleagues to cover absences; a physiotherapist to deliver the exercise programme, with a colleague to cover absences; NHS premises in the community suitable for spinal manipulation; and premises in the community suitable for exercise classes.We trained physiotherapists with at least two years' experience since qualification to deliver this programme. —A multidisciplinary group developed a package of techniques representative of those used by the UK chiropractic, osteopathic, and physiotherapy professions.10 The three professional associations agreed to the use of this package in this trial.Similar numbers of qualified manipulators from each of these professions treated participants.
They all had a minimum of two years' clinical experience and were skilled in a range of manipulative techniques, including high velocity thrusts.10 Participants randomised to private manipulation received treatment in manipulators' own consultation rooms.