Hunter 2012.

Study characteristics
Methods	Two‐arm RCT Number analyzed/randomized: 44/52 Statistical analysis: not conducted because it was a feasibility study (trial registration number ISRCTN94142364) Funding source: Research and Development Office, Northern Ireland, Strategic Priority Funding and Department for Employment and Learning, Northern Ireland, UK Ethical approval and informed consents obtained
Participants	Participant recruitment: by general practitioner Setting: NR Inclusion criteria: 1) having chronic nonspecific LBP for at least 12 weeks; 2) if there was associated buttock and leg pain, back pain must be the chief complaint; 3) ≥ 60 years; 4) having an imaging check of the lumbar spine within the past year Exclusion criteria: 1) spinal tumor, infection or fracture; a bleeding diathesis; epilepsy; a cardiac arrhythmia or pacemaker; dementia; any serious, active medical condition that precluded safe participation (i.e. myocardial infarction within the past 3 months); 2) neurological involvement (loss of sensation, motor weakness or loss of reflexes); planned or scheduled lumbar surgery; a history of lumbar surgery; a significant psychiatric disability; inflammatory arthritis; 3) prior use of acupuncture for back pain; 4) uses of systemic corticosteroids, muscle relaxants, narcotic medications, anticoagulants, and epidural steroid injections within the past 3 months; the involvement in litigation related to back pain; 5) refusal to be randomized Mean age: 42.8 years Gender (female): 63 % Pain duration (mean ± SD): 9.9 ± 9 years Pain intensity (mean): 4.6 (VAS, 0 to 10)
Interventions	1) GROUP 1: auricular acupuncture + exercise (standardized) Acupuncture points: Shen Men, Lumbar Spine, and Cushion Depth: NR De Qi: NR Sessions: used conventional auricular stud needles during the first 6 weeks before each exercise class, and left the needles in situ for 48 hours Acupuncturist experience: two chartered physiotherapists 2) GROUP 2: exercise The participants had exercises for 1 hour per week for 6 weeks: "The exercise program consisted of a 10 min warm‐up, a series of exercise stations involving core strengthening, flexibility, and cardiovascular exercise, a 10 min cool down, and a period of relaxation. Each exercise station consisted of three levels: easy, moderate, and hard". "This exercise program is underpinned by cognitive behavioural therapy principles designed to change participants behaviour by modifying their attitude to their LBP.” Co‐intervention: received a 12‐week intervention program consisting of 6 weeks of supervised exercise followed by 6 weeks of unsupervised exercise with telephone support Duration of treatment: 12 weeks Duration of follow‐up: 6 months
Outcomes	1) Pain intensity: VAS (0 to 10) 2) Back‐specific function status: ODI (0 to 50) 3) Quality of life: EuroQol 5D (EQ‐5D, ‐0.59 to 1); higher values better 4) Others relevant: IPAQ‐MET, International Physical Activity Questionnaire‐MET/min/week; HHQ‐CAM, Holistic Complementary and Alternative Health Questionnaire‐Complementary and Alternative Medicine; HHQ‐HH, Holistic Complementary and Alternative Health Questionnaire‐Holistic Health subscale Assessment times: 13 weeks and 6 months after beginning of treatment Costs: NR Adverse effects: pain (14%), redness (2%), and minor bleeding (1%) at the site of needle insertion; swelling (n = 1) around the needle insertion site due to rheumatoid arthritis
Notes	Conclusion: Auricular acupuncture was safe and demonstrated additional benefits when combined with exercise for people with chronic LBP, which requires confirmation in a fully powered RCT. Language: English For results, see comparison 6.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random numbers were generated by computer.
Allocation concealment (selection bias)	Low risk	Kept in secured location and only accessible by an independent trial statistician
Blinding of participants (performance bias) All outcomes	High risk	Not possible between the studied groups
Blinding of personnel /care providers (performance bias) All outcomes	High risk	Not possible
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded participants reported the subjective outcomes.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Dropout rates were < 20% and comparable between groups; the reasons were acceptable.
Intention‐to‐treat‐analysis (attrition bias)	Unclear risk	A feasibility RCT without statistical analysis
Selective reporting (reporting bias)	Unclear risk	No reported P value
Group similarity at baseline (selection bias)	Low risk	Similar baselines
Co‐interventions (performance bias)	High risk	Higher percentage of participants in the exercise group thought that the treatment received had changed the number of pain relieving tablets.
Compliance bias (performance bias)	Unclear risk	Exercise group had 8% higher attendance rate than AA + exercise group.
Timing of outcome assessments (detection bias)	Low risk	Same assessment time
Other bias	Low risk	Not identified