Table 2.
Summary of findings of treatment effects and certainty of the evidence (GRADE) included for all comparisons
| 1. Sham treatment (ST) compared with manual therapies (MT) | ||||||
| Patient or population: back pain Intervention: ST Comparison: MT | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with MT | Risk with ST | |||||
|
Pain improvement assessed with: VAS score§ Scale from: 0 to 100 |
MD 3.86 higher
(3.29 lower to 4.43 higher) |
– | 805 (15 RCTs) |
⨁◯◯◯ VERY LOW†‡ |
A small effect, not clinically relevant, in pain improvement was detected in favour of MT. This analysis excluded two trials (one suspected of publication bias, one used a different scale) which increased heterogeneity levels but did not affect overall efficacy meaningfully. | |
| Adverse events assessed with: no of AE occurred | 144 per 1.000 |
121 per 1.000
(79 to 184) |
RR 0.84
(0.55 to 1.28) |
531 (6 RCTs) |
⨁⨁◯◯ LOW† |
Pooled data from six studies did not show any difference in AE occurrence between ST and MT. |
| Drop-outs rate assessed with: no of participants that leaved the study | 174 per 1.000 |
171 per 1.000
(134 to 218) |
RR 0.98
(0.77 to 1.25) |
1238 (11 RCTs) |
⨁⨁◯◯ LOW† |
Pooled data from 11 trials did not show difference in drop-out rate between ST and MT. |
| 2. ST compared with no treatment | ||||||
|
Patient or population: back pain Intervention: ST Comparison: No treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) |
No of participants (studies) |
Certainty of the evidence (GRADE) |
Comments | |
| Risk with no treatment | Risk with ST | |||||
|
Pain improvement assessed with: VAS score Scale from: 0 to 100 |
MD 5.84
lower (20.46 lower to 8.78 higher) |
– | 177 (3 RCTs) |
⨁◯◯◯ VERY LOW†‡¶ |
Pooled data from three trials, highly inconsistent, showed no differences between ST and no treatment group in pain improvement. | |
| Drop-outs rate assessed with: no of participants that leaved the study | 150 per 1.000 |
123 per 1.000
(65 to 233) |
RR 0.82
(0.43 to 1.55) |
225 (4 RCTs) |
⨁◯◯◯ VERY LOW†¶ |
Very low quality of evidence suggests no differences in drop-out rate between ST and no treatment. |
GRADE Working Group grades of evidence.
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
†The majority of trials were judged as poor quality according to AHRQ standards.
‡Most of the studies were small trial
§Heterogeneity levels at 85%.
¶Number of participants <400.
AE, adverse effect; GRADE, Grading of Recommendations Assessment, Development and Evaluation; MD, Mean difference; RCT, randomised controlled trials; RR, Risk ratio; VAS, Visual Analogue Scale.