| Methods |
Cluster randomisation (21 voluntary GPs were randomised). Each doctor recruited a median of 2.5 (Control) and 3 patients (NRT group) (range 1 to 14). |
| Participants |
104 adult patients (28 to 61) presenting an episode of LBP lasting at least 14 days in spite of conventional treatment were consecutively recruited from primary care consultations in Palma de Mallorca (Spain).
Intensity of pain and duration of current episode were higher in the NRT group while length of time on sick leave before inclusion was slightly higher in the control group. Median duration of the current episode of LBP = 17.5 days (Control) and 48.13 (NRT group). About 90% in the NRT group and 82% in the control group had experienced one or more previous episodes. |
| Interventions |
Patients in the treatment group received NRT intervention (mean number of procedures 1.44) in addition to the standard care for LBP in the primary care setting. Patients in the control group received the so‐called standard protocol for LBP. |
| Outcomes |
1) Measures of change with respect the baseline (Day 60‐Day 0):
a) Pain relief (local and referred), b) Disability, c) Quality of life, and d) Side effects. 2) Measures at the end of 1‐year follow‐up period: a) number of days off work, b) consumption of resources. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
|
| Allocation concealment? |
High risk |
As physicians in this study were randomized not to treat with A versus B, but to refer patients or not to refer patients to a specialized unit on Neuroreflexotherapy, we believe that in this particular case the risk of selection bias was low. |
| Blinding?
All outcomes ‐ patients? |
High risk |
not applicable |
| Blinding?
All outcomes ‐ providers? |
High risk |
not applicable |
| Blinding?
All outcomes ‐ outcome assessors? |
High risk |
not applicable |
| Incomplete outcome data addressed?
All outcomes ‐ drop‐outs? |
High risk |
|
| Similarity of baseline characteristics? |
High risk |
|
| Co‐interventions avoided or similar? |
Low risk |
Patients were allowed to continue pretrial meds if needed |
| Compliance acceptable? |
Unclear risk |
Unclear from text |
| Timing outcome assessments similar? |
Low risk |
|
