[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
physiotherapy
collar
wait and see
Included criteria: Age 18-75 years, symptoms for less than one month, arm pain on a visual analogue scale of 40mmor more, and radiation of arm pain distal to the elbow, plus at least one of provocation of arm pain by neck movements, sensory changes in one or more adjacent dermatomes, diminished deep tendon reflexes in the affected arm, or muscle weakness in one or more adjacent myotomes.
Excluded criteria: Clinical signs of spinal cord compression, previoustreatment with physiotherapy or a cervical collar,and insufficient understanding of the Dutch or Englishlanguage.
Intervention Characteristics
physiotherapy
collar
wait and see
Continuous:
Dichotomous:
Sponsorship source: The salary for the research nurse was paid by the Non-profitFoundation, dr Eduard Hoelen Stichting, Wassenaar, Netherlands.
Country: Nederlands
Setting: Neurology outpatient clinics in three Dutch Hospitals
Comments:
Authors name: Barbara Kuijper
Institution: Maasstad Hospital, Department of Neurology
Email: kuijperb@maasstadziekenhuis.nl
Address: P O Box 9119, 3078 AC, Rotterdam, Netherlands
Identification:
Per KjæR Kuijper 2009
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
manual therapy
exercises
manual therapy+exercises
Included criteria: 4 positive fundings: Spurling, positive distraction, upperlimb test for median nerve , ipsilateral rotation less than 60 degrees
Excluded criteria: medical condition hindering routine practice as Rheumat. Arthritis, cervical/thoracal surgery etc.
Intervention Characteristics
manual therapy
exercises
manual therapy+exercises
Continuous:
Sponsorship source: Not declare
Country: US
Setting: Outpatient Physiotherapy Department
Comments: payment model at hospital not mentioned
Authors name: John Ragonese
Institution: Outpatient Rehabilitation Department at Loyola Medical Center
Email: not available
Address: Chicago, IL
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Adverse outcomes:
Wrong patient population
Wrong patient population
Wrong patient population
Wrong intervention
Wrong outcomes
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Comment: For each of the three participating hospitals, randomisationwas based on a computer generated sequencethat was kept in a separate box with sealed envelopes.The boxes had been prepared by an employee fromthe Department of Biostatistics who was not otherwiseinvolved in the study. No other stratification or blockingprocedure was used.
Comment: Sequence generation not described. Block randomization refers to the size of groups, not real block randomization.randomised by opening opaque envelopes
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Quote: "The boxes had been prepared by an employee from the Department of Biostatistics who was not otherwise involved in the study."
Comment: All envelopes were sequentially numbered. After thepatient had given informed consent, the investigatoropened the envelope with the next consecutive numberand informed the patient about the treatment allocated.
Comment: Generation of sequence not described
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Comment: Patients and investigators were not blinded to the type of treatment.
Comment: Not possible to blind patient and clinician in this type of studies
Detection bias due to knowledge of the allocated interventions by outcome assessors
Quote: "At entry and at three weeks, six weeks, and six months after randomisation, the patients filled out all the outcome scales in the presence of, but without interference from, the research nurse who also acted as data manager."
Comment: it is not stated the the nurse was not involved in the treatment arms
Comment: After 3 weeks evaluated by therapist blinded to treatment allocation
Attrition bias due to amount, nature or handling of incomplete outcome data
Quote: "We imputed missing values on the basis of the last observation carried for- ward technique."
Comment: There is a relative low drop out but it cannot be determined in the early outcomes
Comment: No report of how missing data were delt with if any, no reports of drop outs, attrition or exclusion
Reporting bias due to selective outcome reporting
Comment: Reporting according to the published protocol on primary outcomes
Comment: Standard outcomes of pain and disability reported suggesting no selective outcome reporting
Bias due to problems not covered elsewhere in the table
Comment: conserns about adherence to treatment protocols which may weaken the results
Comment: There are no analyses of baseline statisticsthere is no power calculation, amount of participants very low