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. 2020 Dec 11;2020(12):CD013814. doi: 10.1002/14651858.CD013814

Cesare 2011.

Study characteristics
Methods Two‐arm RCT
Number analyzed/randomized: 60/62
Statistical analysis: ITT analysis; ANCOVA; power analysis
Funding source: NR
Ethical approval and informed consent obtained
Participants Participant recruitment: at outpatient clinic directly
Setting: outpatient clinic in Italy
Inclusion criteria: 1) LBP > 6 months; 2) aged > 45 years; 3) no pharmacological therapy for other systemic pathologies; 4) no previous treatment with mesotherapy for chronic LBP
Exclusion criteria: 1) presence of neurological pathologies; concomitant severe rheumatic disease; systemic pathologies (e.g. diabetes); 2) surgical intervention in 3 months prior to the study; 3) psychiatric pathologies or patients undergoing psychotherapeutic treatment or physical treatment in 5 weeks prior to the study
Age (mean): 52.5 years
Gender (female): 55%
Pain duration (mean): 4.8 years
Pain intensity (mean): 7.4 (VAS, 0 to 10)
Interventions 1) GROUP 1: acupuncture mesotherapy (standardized)
Local anesthetic (a drop of lidocaine, 2%) injected at 18 points for both groups before acupuncture.
Acupuncture points: local bilateral points (GB30, BL31, BL52, GV3, Ashi points); bilateral distal points (GB34, GB41, BL60, KI4, TE5)
Depth: NR
De Qi: NR
Sessions: 4 sessions (1/week for 4 weeks)
Acupuncturist experience: 3 years of acupuncture training and 8 years of clinical experience
2) GROUP 2: trigger point mesotherapy
A number of the 18 local superficial trigger points of the most important accessible muscles in lumbar tract and hip were treated (quadratus lumborum – 2 bilateral trigger points: one at the angle between the crest of the ilium and transverse processes of L4 and the other at the transverse processes of L1‐L2; iliopsoas muscle ‐ 2 paravertebral bilateral points: one on the D12 thoracic vertebrae and the other on L2 lumbar vertebrae; gluteus maximus – 3 bilateral trigger points: all on the medial superior portion of sacrum region; piriformis muscle – 2 bilateral points: one at the junction between the middle and the outer third of the piriformis line and the other one at medial end of piriformis line)
Co‐intervention: none
Duration of treatment: 4 weeks
Duration of follow‐up: 12 weeks after starting treatment
Outcomes 1) Pain intensity: VAS (0 to 10) and VRS (verbal rating scale, 0 to 6); lower values better
2) The quality and intensity of pain: McGill Pain Questionnaire (MPQ) Short Form, lower values better
3) Back‐specific function status: Roland Morris Disability Questionnaire (RMDQ, 0 to 24), and Oswestry Low Back Pain Disability Questionaire Index (ODI, 0 to 50); for both, lower values better
Assessment times: 4 and 12 weeks after beginning of treatment
Costs: NR
Adverse effects: five participants in acupuncture group reported slight neck pain
Notes Conclusion: "Our results suggest that the response to ACP mesotherapy may be greater than the response to TRP mesotherapy in the short term follow‐up."
Language: English
For results, see comparison 5.
Be cautious to the result related with the paper due to extremelly small SD values of pain reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used random numbers from a statistics textbook
Allocation concealment (selection bias) Low risk Used sealed, sequentially numbered, opaque envelopes
Blinding of participants (performance bias) 
All outcomes Unclear risk Authors claimed "blinding was maintained until the end of the study", but did not describe the details.
Blinding of personnel /care providers (performance bias) 
All outcomes High risk Not possible
Blinding of outcome assessment (detection bias)
All outcomes Low risk VAS (pain) scores were recorded by participants reported to be blinded; other outcomes recorded by blinded assessor.
Incomplete outcome data (attrition bias)
All outcomes Low risk Dropout rate was low (< 5%) and the reasons were acceptable.
Intention‐to‐treat‐analysis (attrition bias) Low risk ITT analysis using last value carried forward for missing values
Selective reporting (reporting bias) Low risk All of the outcomes were reported.
Group similarity at baseline (selection bias) Low risk Similar baseline characteristics
Co‐interventions (performance bias) Low risk No co‐intervention was used.
Compliance bias (performance bias) Low risk All subjects completed the treatment.
Timing of outcome assessments (detection bias) Low risk The outcomes were collected at 4 and 12 weeks.
Other bias Low risk Not identified