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. 2020 Apr 16;2020(4):CD013581. doi: 10.1002/14651858.CD013581

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)
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
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
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