Persson 1997.
Methods | C: sealed envelopes outcome assessor not blind Exclusions during trial: None Losses to FU: 2 | |
Participants | Sweden 81 patients (46% women) Mean age 47 years Clinical and radiological (MRI or CT‐myelography) evidence of cervical radiculopathy | |
Interventions | Rx: ACDF (with allograft, n=26) or cervical laminectomy Control: physiotherapy or cervical collar | |
Outcomes | Pain (VAS) paraesthesia and sensory loss at onset, 3, 12 and 16 months after treatment | |
Notes | Ex: spinal cord compression, absence of radiological evidence of root compression
FU: 16 months
Cross‐overs (patients allocated in conservative groups undergoing surgery): 6 (between 3 and 12 months); 1 allocated to physiotherapy and 5 allocated to collar group 3 patients allocated to the surgical group refused surgery because of spontaneous improvement."Intention to treat principle" was applied throughout. 8 surgically‐treated patients underwent a second operation between 3 and 12 months (6 in adjacent levels, 1 because of graft infection, 1 had exploration of the brachial plexus) 11 patients in the surgery group and 12 in the collar group received physiotherapy |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | 'randomized by the use of sealed envelopes' |
Allocation concealment? | Unclear risk | not stated |
Blinding? patients | High risk | patients aware of intervention group |
Blinding? care providers | Unclear risk | not stated, but unlikely |
Blinding? outcome assessor | High risk | 'the same physiotherapist [who completed the baseline assessment], who did not take part in the treatment, also administered the post‐treatment measurements'; but patients in the collar group were wearing their collars. |
Incomplete outcome data addressed? Withdrawal/drop‐out rate | Low risk | |
Incomplete outcome data addressed? Intention‐to‐treat analysis | Low risk | 'allocation to the surgical group was retained in accordance with the 'intention to treat' principle. In the physiotherapy and cervical collar groups, all patients carried out the allocated treatment'. |
Free of selective reporting? | Unclear risk | muscle strength, function (assessed by Sickness Impact Profile) and mood (assessed by Mood Adjective Check List) were investigated but data inadequate for quantitative comparisons |
Similarity of baseline characteristics? | Low risk | |
Co‐interventions avoided or similar? | Unclear risk | 11 patients in the surgery group and 12 in the collar group received physiotherapy; '1 patient in the physiotherapy group and 5 patients in the collar group underwent surgery because the result of the conservative therapies was unsatisfactory' |
Compliance acceptable? | Low risk | |
Timing outcome assessments similar? | Low risk |
C‐Concealment of allocation; Rx‐Treatment; JOA‐Japanese Orthopaedic Association; ACDF‐Anterior Cervical Decompression and Fusion; VAS‐Visual Analogue Scale; Ex‐Exclusion Criteria; C‐inadequate; B‐unclear