| Methods |
RCT; Randomization procedure not described |
| Participants |
Department of Rheumatology, University Hospital Leiden, The Netherlands. Patients recruited from a university based outpatient clinic (median duration of pain was 8 years) and a large general practice in a rural area (median duration of pain was 18 days).
41 patients with iliac crest pain syndrome. Exclusion criteria were: diagnosis of sciatica, ankylosing spondylitis, malignancy, infection, spondylolysthesis, severe degenerative disc disease or fibromyalgia. |
| Interventions |
Single local injection at the point of maximal tenderness over the medial part of the iliac crest.
(1) Injection of 5 ml lignocaine 0.5%.
(2) Injection of 5 ml isotonic saline. |
| Outcomes |
Timing: at baseline and 10 minutes, 7 days, 14 days and 2 months after the injection.
At 14 days the mean pain score in the lignocaine group was significantly lower than in the control group. In the lignocaine group 52% of patients improved at 14 days compared to 30% in the control group. This difference was not statistically significant. Among those who improved with lignocaine, the beneficial effect continued for at least 2 months in 80% of the patients. |
| Notes |
Side effects: 2 patients in the lignocaine group and 3 in the saline group complained of a painful injection or increase of pain for some hours after the injection. Nausea some hours after the injection occurred in 2 of the patients treated with lignocaine and in 1 patient treated with saline. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Randomization procedure not described |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes ‐ patients? |
Low risk |
|
| Blinding?
All outcomes ‐ care providers? |
Low risk |
|
| Blinding?
All outcomes ‐ outcome assessors |
Low risk |
|
| Incomplete outcome data addressed?
All outcomes ‐ drop‐outs? |
Low risk |
|
| Incomplete outcome data addressed?
All outcomes ‐ ITT analysis |
Low risk |
|
| Similarity of baseline characteristics? |
Low risk |
|
| Co‐interventions avoided or similar? |
Unclear risk |
unclear from text |
| Compliance acceptable? |
Low risk |
|
| Timing outcome assessments similar? |
Low risk |
|
