Haake 2007.

Study characteristics
Methods	Three‐arm RCT Number analyzed/randomized: 1117/1802 Statistical analysis: ITT analysis; Fisher exact test; power analysis Funding source: German public health insurance companies Ethical approval and informed consent obtained
Participants	Participant recruitment: newspapers, magazines, radio, and television Setting: 340 outpatient practices in Germany Inclusion criteria: 1) clinical diagnosis of chronic LBP (≥ 6 months); 2) Van‐Korff Pain Score ≥ Grade I and HFAQ < 70%; 3) therapy‐free interval ≥ 7 days; 4) aged older than 18 years; ability to speak, read, and write German; 5) no previous treatment with needle‐acupuncture for chronic LBP Exclusion criteria: 1) previous treatment with acupuncture for any other indication in the last year; 2) sciatica or other neurologic disorders; 3) history of disc or spinal surgery; 4) history of fracture of the spine (e.g. osteoporosis, trauma); 5) infections or tumors of the spine; 6) systemic bone or joint disorders (e.g. rheumatoid arthritis); 7) scoliosis, kyphosis; 8) hemorrhagic disorders or anticoagulant therapy; 9) skin disease in the area of acupuncture; 10) chronic pain caused by other diseases; 11) abuse of drugs or pain medication; 12) pregnancy; 13) epilepsy; 14) person included in other studies Age (mean ± SD): 50 ± 15 years Gender (female): 60% Pain duration (mean): 8 years Pain intensity (mean): 67.8 (Von Korff Chronic Pain Grade Scale – 3 sub‐scales in pain, 0 to 100)
Interventions	1) GROUP 1: verum acupuncture (semi‐standardized) Acupuncture points: fixed points and additional points (from a prescribed list) chosen individually on the basis of traditional Chinese medicine diagnosis Depth: 14 to 20 needles inserted to a depth of 5 to 40 mm, depending on the site De Qi: by manual stimulation Sessions: 10 sessions (30 min, 2/week for 5 weeks); 5 additional sessions if subjects experienced a 10% to 50% reduction in pain intensity after the 10th session Acupuncturist experience: physicians of various specialisations who had at least 140 hours of acupuncture training in Germany 2) GROUP 2: sham acupuncture Standardized points on either side of the lateral part of the back and on the lower limbs to avoid all known verum points or meridians; 14 to 20 needles inserted superficially (1 to 3 mm), without stimulation 3) GROUP 3: conventional therapy The treatment included 10 sessions with personal contact with a physiotherapist who administered physiotherapy, exercise, etc. Physiotherapy was supported by NSAIDs or pain medication up to the maximum daily dose during the therapy period. Co‐intervention: for acute episodes of pain, only rescue medication was permitted in all three groups (NSAIDs for ≤ 2 days per week, up to the maximum daily dose during the therapy period and only 1 day per week during follow‐up). Use of any additional therapies for pain during the entire study period was prohibited. Duration of treatment: 6 weeks Duration of follow‐up: 6 months after beginning of treatment
Outcomes	1) Pain intensity: CPGC‐pain (0 to 100) and numbers of participants with 33% improvement of CPGC‐pain; lower values better 2) Back‐specific functional status: HFAQ (0 to 100) and numbers of participants with 12% improvement of HFAQ; higher values better 3) Quality of life: subscales of SF‐12 in physical and mental health component; higher values better 4) Global assessment: 6‐point scale, with 1 meaning very good and 6 meaning fail Assessment times: 6 weeks, 3 months, and 6 months after beginning of treatment Costs: NR Adverse effects: 476 clinically relevant adverse effects were reported by 257 participants (22.6%) with no difference between therapy groups (P = 0.81).
Notes	Conclusion: "Low back pain was improved after acupuncture treatment for at least 6 months; effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy". Language: English For results, see comparisons 1, 3 and 4.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Stratified randomisation was generated by computer program.
Allocation concealment (selection bias)	Low risk	Allocation was done by fax.
Blinding of participants (performance bias) All outcomes	Low risk	Participants were blinded between verum and sham acupuncture, and credibility was tested.
Blinding of personnel /care providers (performance bias) All outcomes	High risk	Not possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Assessors were blinded and blinded participants reported some outcomes.
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropout rates at each time point were around twice higher in the conventional group than acupuncture groups. Reasons for missing were not reported.
Intention‐to‐treat‐analysis (attrition bias)	Low risk	The primary analysis used ITT.
Selective reporting (reporting bias)	Low risk	All outcomes were reported.
Group similarity at baseline (selection bias)	Low risk	Baseline characteristics were similar.
Co‐interventions (performance bias)	High risk	Rescue medication was taken differently between acupuncture and conventional groups.
Compliance bias (performance bias)	Low risk	Similar average sessions were received by subjects among the 3 groups, which was acceptable.
Timing of outcome assessments (detection bias)	Low risk	Not identified
Other bias	Low risk	Not identified