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. 2016 Jul 28;2016(7):CD004598. doi: 10.1002/14651858.CD004598.pub4

Rodriguez 2005.

Study characteristics
Methods RCT, parallel design
Participants N= 82
Mean age (no SDs provided):
Group 1: 44.1 years
Group 2: 46.1 years,
Sex:
Group 1: 36.6% male
Group 2: 46.3% male
Upper limb CRPS (type I or type II) with presence of pain mediated by the sympathetic nervous system (defined as a decrease in resting pain by 50% with a stellate ganglion block)
Diagnostic criteria: IASP (Merskey 1994; Reinders 2002)
Inciting event:
71.4% of CRPS cases were secondary to accidental or violent trauma and 18% occurred following surgical procedures.
Mean duration of symptoms (no SDs provided):
Group 1: 253.7 days
Group 2: 213.4 days
Medico‐legal factors:
Group 1: 14.6% had a compensation claim
Group 2: 24.4% had a compensation claim
Previous treatment: participants were excluded if they had previous stellate ganglion blocks; no other previous treatment reported
Concomitant treatment: Group 1 also received physical therapy and pharmacological treatment
Interventions Group 1: SGB, physical therapy and pharmacological treatment
Site of block: paratracheal at the height of the cricoid cartilage
Number of blocks: 5
Type of substance injected: 10 cc of volume with equal parts of 2% lidocaine and 0.5% bupivacaine
Evaluation of technical adequacy: increase in temperature of at least 1° C of the hand and face (affected side) and the presence of Horner's syndrome (ptosis of the upper eye lid and conjunctivitis)
Group 2: Physical therapy and pharmacological treatment only(Control group):
Received physical therapy and pharmacological treatment
Outcomes Pain intensity (VAS). Measured at baseline, 1 month and 2 months. Exact follow‐up time appears to be variable among participants (i.e. followed for more than 2 months in some).
Therapeuctic efficacy: number of participants with at least 50% reduction in the pain. Measured at 2 months postintervention.
Efficacy: (incidence of pain in control group − incidence of pain in the SGB group)/incidence of pain in the control group * 100
Absolute risk reduction (incidence of pain in control group − incidence of pain in the intervention group). Measured at 2 months postintervention.
NNTB = 1/ARR (calculated at 2 months postintervention)
Relapse (return of pain to less than 50% reduction or return of pain to baseline levels or above); determined at 2 months postintervention
Country of origin Colombia
Study aim To determine the analgesic efficacy of the stellate ganglion blockade (SGB) in the alleviation of pain mediated by the sympathetic nervous system in patients with Complex Regional Pain Syndrome
Notes This is the first published study by Rodriguez. There are 2 other published studies and one IASP abstract that use an identical study design. It is unclear if all the studies represent the same cohort. We attempted to contact the authors 3 times with no success.
This study was translated and interpreted by a researcher fluent in Spanish. The study author, TS, worked with the researcher to fully interpret and score.
Funded by Colciencias and the Universidad Libre Seccional Cali. No conflict of interest stated. No adverse events reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomized"
Comment: method of randomisation unclear
Allocation concealment (selection bias) Low risk Opaque envelopes used; randomly given to each participant
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "double blind"
Comment: Probably not. Index and control groups are not indistinguishable, and success of blinding was not tested
Blinding of outcome assessment (detection bias)
All outcomes High risk The investigator was reported to be blinded; however, outcomes were self reported and participants were likely not blinded
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Participants that dropped out or underwent surgery were excluded from the analysis. The number of excluded participants per group is not reported.
Selective reporting (reporting bias) High risk No pain scores were given and time to relapse was unclear
Adequate sample size? High risk N = 82 (41 in each group)
Adequate duration of follow‐up? Low risk Follow‐up of 2 months
Free of other bias? Unclear risk No baseline data given on pain intensity; unsure if groups were similar at baseline