| Methods |
Randomized allocation by random numbers table. Double blind (participants and observers). |
| Participants |
Sansum Medical Clinic, Santa Barbara, California
81 participants with chronic non‐specific low back pain, duration over 1 year.
Experimental: mean age (range) 45 (23‐70), 18 males, years of pain (range) 8.98 (1‐30), 12 with radiation of pain into legs.
Control group: mean age (range) 43 (23‐70), 20 males, years of pain (range) 10.72 (1‐35), 12 with radiation of pain into legs. |
| Interventions |
Experimental group (E) (n = 40):
Injection of lumbopelvic ligaments with 60 ml of 0.5% lignocaine followed by forceful manipulation and injection of gluteal tender points with triamcinolone/lignocaine.
Then weekly injections of lumbopelvic ligaments with glucose (12.5%) glycerine (12.5%) phenol (1.25%) 0.25% lignocaine, 20 ml in total. 6 injection treatments.
Controls (C) (n = 41):
Injection of lumbopelvic ligaments with 10 ml of 0.5% lignocaine followed by non‐forceful manipulation
and injection of gluteal tender points with lignocaine.
Then weekly injections of lumbopelvic ligaments with 0.9% saline, 20 ml in total. 6 injection treatments.
Both groups:
Encouraged to do previously painful activities and 150 flexion exercises daily. |
| Outcomes |
Mean (SD) of outcomes at baseline and at 1, 3 and 6 months after intervention
1. VAS pain: (E) 3.78 (1.20), 2.13 (1.39), 1.77 (1.39), 1.50 (1.34); (C) 3.99 (1.22), 3.06 (1.86), 2.93 (1.60), 3.08 (1.77).
2. Roland disability questionnaire added with 9 questions from Waddell's chronic disability index: (E) 11.45 (5.25, 4.00 (3.90), 4.70 (4.62), 3.43 (4.61); (C) 11.82 (5.31); 8.37 (6.66), 8.49 (6.66), 8.29 (7.04) |
| Notes |
Methodological quality score 10/11. |
| 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? |
High risk |
|
| Compliance acceptable? |
Low risk |
|
| Timing outcome assessments similar? |
Low risk |
|
