| Methods |
Randomized allocation by random numbers table. Double blind (participants and observers). |
| Participants |
Sansum Medical Clinic, Santa Barbara, California
80 participants with chronic non‐specific low back pain, duration over 6 months.
Experimental: mean age (SD) 44.6 (8.6), 21 males, years of pain (SD) 11.2 (7.9).
Control group: mean age (SD) 43.5 (9.2), 20 males, years of pain (SD) 11.8 (10.1). |
| Interventions |
Experimental group (E) (n = 39, due to withdrawal of 1 participant due to development of acute radiculopathy following an athletic injury):
Weekly injections of lumbopelvic ligaments with glucose (12.5%) glycerine (12.5%) phenol (1.25%) 0.25% lignocaine, up to 30 ml in total. 6 injection treatments.
Control group (C) (n = 40):
Weekly injections of lumbopelvic ligaments with 0.25% lignocaine, up to 30 ml in total. 6 injection treatments.
Both groups:
Initial injection of lumbopelvic ligaments with 0.5% lignocaine followed by forceful manipulation and injection of gluteal tender points (if present) with triamcinolone/lignocaine; 200 flexion/extension exercises daily and 1 mile walk 5 times per week |
| Outcomes |
Mean (SD) of outcomes at baseline and at 6 months after intervention
1. VAS pain: (E) 4.88 (1.30), 2.29 (1.67); (C) 4.56 (1.12), 2.85 (1.88)
2. Roland disability questionnaire added with 9 questions from Waddell's chronic disability index: (E) 9.36 (3.56), 4.04 (3.71) (C) 8.25 (3.26), 4.38 (4.05). |
| Notes |
Methodological quality score 11/11 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Randomized allocation by random numbers table. |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
| Blinding?
All outcomes ‐ patients? |
Low risk |
|
| Blinding?
All outcomes ‐ 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? |
Low risk |
|
| Compliance acceptable? |
Low risk |
|
| Timing outcome assessments similar? |
Low risk |
|
