| Methods |
Randomized allocation by random numbers table. Double blind (participants and observers). |
| Participants |
Inala Health Centre General Practice, Brisbane, Australia
110 participants with chronic non‐specific low back pain, duration over 6 months.
Experimental: mean age (SD) 51.5 (10.6), 32 males, years of pain (SD) 14.8 (10.9), 24 with radiation of pain into legs.
Control group: mean age (SD) 49.4 (10.4), 31 males, years of pain (SD) 13.8 (9.3), 23 with radiation of pain into legs. |
| Interventions |
Experimental group (E) (n = 54): Fortnightly injections of lumbopelvic ligaments with glucose (20%) and lignocaine (0.2%), 10 to 30 ml, mean number of injection treatments 7
Control group (C) ( n = 56): Fortnightly injections of lumbopelvic ligaments with saline (0.9%), 10 to 30 ml, mean number of injection treatments 7
Both groups:
Superficial injections of lignocaine over deep injection points; oral vitamin C, zinc and manganese supplements daily. Randomly assigned to 40 flexion/extension exercises daily, experimental (n = 28 ), control (n = 27), or normal activity, experimental (n = 26), control (n = 29) . |
| Outcomes |
Mean (SD) of outcomes at baseline and 6, 12 and 24 months after commencing intervention.
1. VAS pain: (E) 51.9 (19.3), 31.4 (26.6), 33.1 (24.5), 32.8 (25.8); (C) 55.0 (20.7), 34.0 (27.5), 36.6 (27.9), 37.1 (24.6). |
| Notes |
Methodological quality score 11/11 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
|
| Allocation concealment? |
Low risk |
A ‐ Adequate |
| Blinding?
All outcomes ‐ patients? |
Low risk |
Patients were blinded to the injection received but those randomly assigned to the daily exercise component could not be blinded to this activity. This does not seem to have affected the outcomes. |
| Blinding?
All outcomes ‐ providers? |
Low risk |
The treating physician was blinded to the injection being given but was aware of the activity status of the patient (see p. 10). This does not seem to have affected the outcomes. |
| Blinding?
All outcomes ‐ outcome assessors? |
Low risk |
Assessors were blinded to both injection and activity statuses. |
| 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? |
Low risk |
|
| Compliance acceptable? |
Low risk |
|
| Timing outcome assessments similar? |
Low risk |
|
