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Table 1 Inclusion/exclusion criteria

From: Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) Trial)

Inclusion criteria Exclusion criteria
Participants with chronic (≥3 months) or recurrent (≥3 episodes in previous 12 months) LBP of mechanical origin with/without radiation to the lower limb Currently or having received treatment for CLBP within the previous 3 months
Males/females between 18–65 years Red flags indicating serious spinal pathology, e.g. cancer, cauda equina lesion
No spinal surgery within the previous 12 months Radicular pain indicative of nerve root compression **
Participants deemed suitable by their GP to carry out an exercise programme Participants diagnosed with severe spinal stenosis, spondylolisthesis, fibromyalgia
Participants deemed suitable by their GP to receive acupuncture treatment History of systemic/inflammatory disease, e.g. rheumatoid arthritis
Participants willing to attend for a 6-week treatment programme of exercise and manual AA Concomitant medical condition that contraindicates acupuncture
Fluency in English (verbal and written) Participants with acute (< 6 weeks) or subacute LBP (6–12 weeks), provided that they have experienced < 3 LBP episodes during the previous 12 months
Access to a telephone (for follow-up support) Previously received auricular acupuncture
Participants categorised as 'low' or 'moderate' activity levels on the International Physical Activity Questionnaire (IPAQ) Participants with any confounding conditions such as a neurological disorder or currently receiving treatment for cancer
  Road traffic accident causing LBP
  History of psychological or psychiatric illness
  Participants having multiple body and/or ear piercings
  Fear of needles
  1. ** In accordance with the Clinical Standards Advisory Group (1994) [21] and the Royal College of General Practitioners Guidelines (Waddell et al., 1999) [22], participants presenting with any or all of the following criteria indicative of radicular pain will be excluded from the study:
  2. (a) unilateral pain usually worse than back pain;
  3. (b) pain generally radiating to the foot or toes;
  4. (c) numbness or paraesthesia in the same distribution;
  5. (d) reduced straight leg raise that produces leg pain;
  6. (e) motor, sensory or reflex change limited to one nerve root.