Postacchini 1988.
Methods | RCT. Randomisation procedure not described Follow‐up time: 6 months (3 weeks, 2 and 6 months) Information extracted from Group I, Subgroup A (acute low back pain) and Group II, Subgroup A (acute back pain radiating to the buttocks and/or thighs and no neurological deficit) |
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Participants |
Population: Group I, Subgroup A = 76 participants and Group II, Subgroup A = 83 participants; in total 159 participants with acute LBP (Group I = 271 participants; Group II = 188 participants. Respectively 235 and 163 after retracting the participants lost to follow‐up or who interrupted or changed their assigned treatment), 34 women, 42 men. Mean age 36.3 years (I A) and 37.7 (II A) (range 17 to 58) Setting: two Low Back Clinics in Rome, Italy, between January 1985 and October 1986 Inclusion criteria: age 17 to 59 years; acute LBP of less than 4 weeks duration, no LBP in preceding six months Exclusion criteria: neoplastic or infectious diseases of the spine, pregnant or nursing women, serious general diseases, psychiatric disturbances or medico‐legal litigation |
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Interventions | NSAID (i): diclofenac 'full dosage', 10 to 14 days (acute participants) (N = 16 and 18 (I A and II A)) Reference treatment (ii): chiropractic manipulation (N = 17 and 18 (I A and II A)) Reference treatment (iii): physiotherapy (N = 15 and 16 (I A and II A)) Reference treatment (iv): bedrest (N = 15 and 14 (I A and II A)) Reference treatment (v): placebo (anti‐oedema gel; (N = 13 and 17 (I A and II A)) | |
Outcomes | Mean improvement on combined pain, disability, and spinal mobility score (range 5 to 32 from poor to excellent clinical status) after 3 wks, 2 and 6 months Group I subgroup A: (i) 3.0, 10.7, 14.0 (ii) 7.5, 9.7, 12.3 (iii) 5.0, 8.4, 10.2 (iv) 5.4, 7.5, 7.3 (v) 1.8, 7.3, 11.0. (ii) significantly better than others after 3 wks; no other differences. After 2 and 6 months no significant differences Group II subgroup A: (i) 4.7, 8.7, 10.3 (ii) 6.3, 9.2, 12.1 (iii) 3.7, 6.0, 10.1 (iv) 4.1, 5.7, 10.3 (v) 2.2, 5.1, 9.8. (ii) significantly better than others after 3 wks (P < 0.05). No other differences. After 2 and 6 months no significant differences No data on side‐effects reported |
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Funding | Not mentioned | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation procedure not described |
Allocation concealment (selection bias) | Unclear risk | An approximately equal number of participants was assigned to each type of treatment. Unclear how this was done |
Blinding of participants and personnel (performance bias) All outcomes ‐ participants | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes ‐ careproviders | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes ‐ outcome assessors | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes ‐ dropouts | High risk | Dropout rate: 13% in Group I (36/271 withdrew), 13% in Group II (25/188 withdrew). Unclear how many in Subgroup A. "The present study did not include a control group of untreated patients, because only a few patients agreed to undergo no treatment and most of them were lost to follow‐up"; this additional placebo group not mentioned in results, not clear how many people in this group originally |
Incomplete outcome data (attrition bias) All outcomes ‐ ITT analysis | Unclear risk | Not mentioned |
Selective reporting (reporting bias) | High risk | In the discussion, they mentioned that a control group of untreated participants was not included, because only a few participants agreed to undergo no treatment and most of them were lost to follow‐up. In the methods, they do not mention this group. |
Similarity at baseline characteristics | Unclear risk | Not mentioned in detail |
Co‐interventions avoided or similar | Unclear risk | Not mentioned |
Compliance acceptable | Unclear risk | Not mentioned |
Timing outcome assessments similar | Low risk | Timing similar |
Other bias | Low risk | None |