Franke 2000.

Methods	Country: Germany Design: 2 x 2 factorial design. 190 patients were randomized. Methods of recruitment: not mentioned. Period of study: 14 months, until the end of 1997. All medications needed to be discontinued before the beginning of the study protocol. Follow‐up: until end of sessions. Drop‐outs: 11 patients (5.8%).
Participants	Settings: study conducted in Bad Andersheim City, Park Rehabilitation Clinic Duration of pain: > one year. Participants needed to speak German to be included. Age: 25 to 55 years (45 ± 8.1), 61% male. Previous treatments: analgesics, anti‐inflammatory drugs, muscle relaxants, antidepressants. Most diagnoses included: lumbar disc prolapse without myelopathy, 28% LBP and 23% ischialgia.
Interventions	1. Acupuncture massage according to Penzel: follow the rules of massage from Physical Medicine and of acupuncture from neural therapy according to Huneke and Quirotherapy Uses a manual metal roller for meridians treatment. Treats one unique point with a special vibrating instrument that stimulates the acupuncture point superficially (not needle insertion). 2. Teil massage (classic Sweedish massage (SM)). The objective is to tonify and defonify muscle structures by increasing circulation in the skin and muscle, decrease adhesions. 3. Individual exercises: Gymnastics with music. Swimming. Ergometric training. Specific low‐back exercises (not specified which). Brügger treatment for musculoskeletal functional diseases (not specified). Posture correction. Muscle strengthening. Increase resistance. Increase in coordination and rhythm. Increase in mobility and flexibility. 4. Group exercises same as individual exercises, but in group mode. Study groups: (1) + (3) (1) + (4) (2) + (3) (2) + (4)
Outcomes	Measured before and after the sessions: a. Pain: VAS (1 to 10 cm). b. Overall improvement: not measured. c. Function: Hanover Function Score Questionnaire for Low Back Pain (LBP) (FFbH‐R) 0 to 100%. d. Physical examination: lumbar flexion and extension (degrees). e. adverse events: not reported. f. Costs: not reported. g. Work‐related outcomes: not measured.
Notes	Authors' conclusions: the observed effect sizes with acupuncture massage are promising and warrant further investigation in replication studies. Acupuncture massage showed beneficial effects for both disability and pain compared with SM. Marked improvement observed in Acupuncture massage + group exercise. Acupuncture massage improved function (with individual or group exercises). Classic massage did not change function. Most decrease in pain occurred in the acupuncture massage + individual exercise group. Acupuncture massage (with individual or group exercise) reduced pain. Mean difference between acupuncture and classic massage groups: 7.0% (function) and 0.8cm Visual Analogue Scale (VAS). ANOVAS: Acupuncture massage is more effective than SM for function (P = 0.008) and for pain (P = 0.038) Both exercises groups (individual or in group) are not statistically significantly different for function (P = 0.55) or for pain (P = 0.55).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random number tables.
Allocation concealment (selection bias)	Low risk	Sealed envelopes.
Blinding (performance bias and detection bias) All outcomes ‐ patients?	High risk	Not feasible for physiotherapists and patients; not possible for investigator due to capacity problems in routine care of the hospital.
Blinding (performance bias and detection bias) All outcomes ‐ providers?	High risk	Not feasible for physiotherapists and patients; not possible for investigator due to capacity problems in routine care of the hospital.
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessor?	High risk	Not mentioned, but because the outcomes were subjective and self‐reported by patients, there is high risk of detection bias.
Incomplete outcome data (attrition bias) All outcomes ‐ drop‐outs?	Low risk	Only 11 patients (5.8%) abandoned the study protocol.
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis?	High risk	3 out of 109 patients changed treatment on own request and were unwilling to complete the questionnaires. A sensitivity analysis was carried out to estimate the robustness of the results. For this reason missing post‐treatment values were replaced by the worst values found between the 10th and 90th percentile of the sample.
Selective reporting (reporting bias)	Unclear risk	Both outcome variables were presented at the end of the study. Pain: VAS (1 to 10cm) and Function: Hanover Function Score Questionnaire for LBP (FFbH‐R) 0 to 100%.
Other bias	Low risk	No other bias was identified.
Similarity of baseline characteristics?	High risk	Due to some differences between groups at baseline, groups‐standardized outcomes were used for analysis.
Co‐interventions avoided or similar?	Low risk	All medications needed to be discontinued before the beginning of the study protocol.
Compliance acceptable?	Low risk	11 patients (5.8%) abandoned the study protocol.
Timing outcome assessments similar?	Low risk	Study period was 14 months. The study had to be finished prior to the intended sample size due to remarkable changes within the German system of welfare regarding rehabilitation.