Ljunggren 1984.
Methods | RCT (method of randomization not described) | |
Participants | 52 hospitalized participants with lumbago‐sciatica and prolapsed lumbar intervertebral discs, admitted to neurological department, and considered for operation. Inclusion criteria: radicular signs L5 or S1 (or both) nerve root; symptoms aggravated or unchanged in last 2‐4 wk. | |
Interventions | T1) Auto‐traction and modified Gertrud Lind: traction force between 33% and 100% of participant's body weight; each pull for some seconds and sometimes up to 2 min. Every treatment lasted about 1 hour. T2) Manual traction and modified manual therapy. Traction force scarcely reached 300 N. Static traction given twice, each pull lasting for 5 min. |
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Outcomes | Immediately AT: overall assessment: no effect (number) T1) 21, T2) 15. Moderate effect (number): T1) 2, T2) 4. Good effect (number) T1) 3, T2) 4. At 2 wk: overall assessment: no effect (number) T1) 21, T2) 16. Moderate effect (number): T1) 1, T2) 4. Good effect (number) T1) 4, T2) 3. At 3 months: identical to results at 2 wk. Pain intensity (VAS) median (SD): BT: T1) 1.3 (0.3‐3.5), T2) 3.5 (0.9‐6.0). AT: T1) 0.8 (0‐1.8), T2) 1.6 (0.2‐3.0). | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No mention of randomization procedure. |
Allocation concealment (selection bias) | Unclear risk | No information provided on allocation concealment. |
Blinding (performance bias and detection bias) All outcomes ‐ participants | Low risk | Participants were not informed about their participation in a randomized investigation with 2 treatment modalities. |
Blinding (performance bias and detection bias) All outcomes ‐ providers | High risk | There is no mention of blinding of the care providers, but it is unlikely that they were. |
Blinding (performance bias and detection bias) All outcomes ‐ outcome assessors | Low risk | The outcome assessor was blinded to the treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes ‐ loss to follow‐up | Low risk | 3 participants (5.8%) were lost to follow‐up. |
Incomplete outcome data (attrition bias) All outcomes ‐ intention to treat analysis | High risk | No intention‐to‐treat analysis was used. |
Selective reporting (reporting bias) | Low risk | Published results included all prespecified outcomes. |
Group similarity at baseline (selection bias) | High risk | Groups were not similar at baseline with regards to level of herniation, duration since first symptoms of sciatica and pain intensity in the lower back. |
Influence of co‐interventions (performance bias) | Low risk | Participants were deprived of long‐term working analgesics later than hours prior to the traction session. |
Compliance with interventions (performance bias) | Low risk | All participants were hospitalized, therefore, the compliance with the given treatment was high. |
Timing of outcome assessments (detection bias) | Low risk | All important outcome assessments for all intervention groups were measured at the same time. |