Zeng 2003.
Study characteristics | ||
Methods | RCT, parallel | |
Participants | N = 60 Age range: 38‐71 Sex: 42 males Shoulder‐hand syndrome following stroke Diagnostic criteria not reported Duration of symptoms; described as "in the early stages of SHS complicated with paralysis" Previous treatment not specified Mean baseline pain, 0‐10 VRS (SD): SGB + rehab group: 6.95 (3.24) Rehab‐only group: 6.85 (3.24) Medico‐legal factors: not reported Concomitant treatments: not reported |
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Interventions | Stellate ganglion block + rehabilitation versus rehabilitation only SGB: anterior entry, transverse process of C7, agent, dose not reported Rehabiliation details: reports "comprehensive treatment" eliminating causes of oedema, avoid weight loading of limb, avoid limb trauma, remove factors causing shoulder pain, movement exercises, joint mobilisations, ice therapy, physical therapy |
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Outcomes | Pain VAS (0 = no pain, 2 = little pain, 4 = frequent mild pain or occasional severe pain, 6 = severe pain but tolerable, 8 = continuous pain and intolerable, 10 = severe pain that couldn't be touched). Pain was measured before treatment, at 10 days and 20 days post‐treatment |
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Country of origin | China | |
Study aim | Effect of stellate ganglion is observed on base of comprehensive rehabilitation treatment (sic) | |
Notes | No statement of financial support or conflict of interest; adverse events not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly divided into two groups" Comment: method of randomisation not reported |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Index and control groups are not indistinguishable and success of blinding was not tested |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participant‐rated outcomes; participants not blinded (as above) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐outs |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes adequately reported on |
Adequate sample size? | High risk | N = 60 (30 in each group) |
Adequate duration of follow‐up? | Unclear risk | 20 days follow‐up |
Free of other bias? | Low risk | Quote: "All patients were in early stage of SHS complicated with paralysis"; "there weren't statistical differences at age, sex, rehabilitation kind" Comments: no difference between groups in age, sex, rehabilitation and duration of symptoms; outcome assessment timing identical |
ARR: absolute risk reduction; BTA: botulinum toxin A; CIBP: continuous infraclavicular brachial plexus block; CRPS: complex regional pain syndrome; CSG: continuous stellate ganglion block; IASP: International Association for the Study of Pain;IV: intravenous; IVRB: intravenous regional blockade; LASB: local anaesthetic sympathetic blockade; NNTB: number needed to treat for an additional beneficial outcome; PRF: pulsed radiofrequency; RCT: randomised controlled trial; RSD: reflex sympathetic dystrophy; SD: standard deviation; SE: standard error; SF‐36: 36‐item short‐form health survey; SGB: stellate ganglion blockade; SMP: sympathetically maintained pain; VAS: visual analogue scale; VRS: verbal report scale.