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. 2010 Jan 20;2010(1):CD001466. doi: 10.1002/14651858.CD001466.pub3

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
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