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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.