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 |