[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT: YES
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT: YES
Baseline Characteristics
Exercise
Exercise + traction
Exercise + over-door traction
Included criteria: Chief complaint of neck pain with symptoms (pain or numbness) extending distal to the acromioclavicular joint or caudal to the superior border of the scapula, age between 18 and 70 years, and a Neck Disability Index (NDI) score of 10 or greater (0-100 scale).
Excluded criteria: History of surgery to the neck or thoracic spine, a recent motor vehicle accident (past 2 weeks), any red flags indicative of a serious or possible nonmusculoskeletalcondition (eg, spinal tumor, fracture, metabolic or infectious disease), a diagnosis of cervical spinal stenosisbased on magnetic resonance imaging or computed tomography imaging, or evidence of cervical myelopathy or central nervous system involvement. Patients were excluded if they knew they would be unable to comply with the treatment or follow-up schedule.
Intervention Characteristics
Exercise
Exercise + traction
Exercise + over-door traction
Continuous:
Dichotomous:
Sponsorship source: Supported by a grant from DJO, LLC
Country: US
Setting: Physical therapy and rehabilitation outpatient clinic
Comments: Solely physioterapists
Authors name: JULIE M. FRITZ
Institution: Department of Physical Therapy
Email: julie.fritz@utah.edu
Address: University of Utah, Salt Lake City, UT
Identification:
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
Physiotherapy + maual traction
Physiotherapy + mechanical traction
Physiotherapy
Included criteria: Recent CR (i.e. onset within the previous 3 months), involvement of spinal nerve with HD and/or intervertebral disc degeneration confirmed by imaging and concordant radiographic and clinical results.
Excluded criteria: History of surgery or bone-ligament damage to the cervicalspine, shoulder disease (rotator cuff syndrome, capsulitis,acromioclavicular arthropathy, shoulder instability or inflammatory arthritis) or carpal tunnel syndrome, ongoing or recent rehabilitation for the current CR and the worsening of pain or intolerance in a manual cervical traction test performed by the clinician during the first consultation.
Intervention Characteristics
Physiotherapy + maual traction
Physiotherapy + mechanical traction
Physiotherapy
Continuous:
Sponsorship source: not declared
Country: Tunesia
Setting: Monastir University Hospital
Comments:
Authors name: A. Jellad
Institution: Service de me´decine physique et re´adaptation
Email: anisjellad@gmail.com
Address: CHU F. Bourguiba, 1753 Monastir, Tunisia
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Alice Kongsted Means calculated from chaneg-scores in bar charts. No SDs available
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Physiotherapy + traction
Physiotherap + sham traction
Included criteria: ● Age 18–70 y● Unilateral upper-extremity pain, paresthesia, or numbness● 3 of 4 tests of clinical prediction rule positive:- Spurling test- Distraction test- Upper-Limb Tension Test 1- Ipsilateral cervical rotation 60°
Excluded criteria: ● History of previous cervical or thoracic spine surgery● Bilateral upper-extremity symptoms● Signs or symptoms of upper motor neuron disease● Medical “red flags” (eg, tumor, fracture, rheumatoid arthritis, osteoporosis,prolonged steroid use)● Cervical spine injections (steroidal) in the past 2 wk● Current use of steroidal medication prescribed for radiculopathy symptoms
Intervention Characteristics
Physiotherapy + traction
Physiotherap + sham traction
Continuous:
Dichotomous:
Sponsorship source: This study was funded by a grant from theSaunders Group.
Country: USA
Setting: Orthopedic physical therapy clinics
Comments: payment for treatment is not clear
Authors name: Ian A. Young
Institution: Dept of Phys Ther, Virginia Commonwealth University-Medical College
Email: youngian@spinesport.org
Address: Box 961,Tybee Island, GA 31328 (USA).
Identification:
Participants:
Study design:
Jesper NøRregaard Per, I would prefer to describe the interventions as described in the paper: Manual therapy, exercise, and intermittent traction/sham traction
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper NøRregaard I report unadjusted means
Dichotomous outcomes:
Jesper NøRregaard Jeg forstår ikke helt denne tabel. Ser ikke noget drop out ved baseline, men 6 i hver gruppe ved follow-up
Adverse outcomes:
Jesper NøRregaard Kan ikke finde rapporterede adverse events
Wrong patient population
Wrong patient population
Wrong comparator
Wrong patient population
Wrong outcomes
Wrong intervention
Wrong outcomes
Wrong patient population
Wrong outcomes
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
How the random fashion was defined is not clear.
Comment: Web based randomization generator in opaque envelopes.
Comment: No reporting on the randomization procedure.
Comment: Numbered, sequential, sealed envelopes containing group allocation for each clinic were opened by the evaluating therapist after the baseline examination.
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
allocation procedures not described
Quote: "Randomiza- tion was conducted using opaque, sealed envelopes prepared prior to beginning enrollment. Allocation sequences were generated in block sizes of 6, 8, or 10, us- ing a web-based randomization generator (www.randomization.com). A research as- sistant opened randomization envelopes after completing all baseline activities."
Comment: The study procedures has not been described in sufficient detail
Quote: "In order to decrease the potential effect of the clinic on treatment outcomes, concealed randomization, stratified by clinic, was used to place patients into treat- ment groups. Numbered, sequential, sealed envelopes containing group allocation for each clinic were opened by the evaluating therapist after the baseline examination."
Comment: In order to decrease the potential effect of the clinic on treatment outcomes, concealed randomization, stratified by clinic, was used to place patients into groups
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
The initial assessment seems not to be blinded, whereas follow up may be is. Not possible to blind in this type of studes
Comment: Qs usual in this type of studies it is not possible to blind either patient or clinician
Comment: Not mentioned, bliniding of participants and clinicians not possible
Comment: In this type of study blinding of patients and clinicians is not possible.
Detection bias due to knowledge of the allocated interventions by outcome assessors
The observer is blinded at six weeks and six months (questionnaires)., The observed is blinded at six weeks and six months (questionnaires)
Comment: Blinded observers are provided
Comment: The outcome assessor was blindedand Patient reported outcome measures
Quote: "Sup- port staff, who were unaware of group assignment, administered all patient self-report measures and grip strength testing as instructed by the therapist."
Comment: Blinding of assessors is described
Attrition bias due to amount, nature or handling of incomplete outcome data
Drop out has been accounted for and relatively small.
Quote: "Analyses were based on intention-to-treat principles, with all pa- tients analyzed with the group to which they were randomized."
Comment: drop outs are unclear
Quote: "One patient crossed from mechani- cal to over-door traction due to difficulty lying supine."
Quote: "None of the patients was lost to follow-up."
Comment: There were no drop outs reported.
Comment: Mixed model and intention to treat togehter with clear reporting of outcomes minimize the risk of bias. Drop out rate is small.
Reporting bias due to selective outcome reporting
Usual outcomes of pain are selected and relevant outcomes overall
Comment: Standard outcome measures of NDI and pain are used and no reason to expect selective outcomes
Comment: Standard measures of outcomes suggest no selective reporting, but no protocol has been published
Comment: The use of standard outcome measures makes it unlikely that selective outcome reporting has occurred. However, no reference to published study protocol or trial registration
Bias due to problems not covered elsewhere in the table
The study is having sound methodology, despite the randomization procedure is not described.
Comment: baseline differences are present for several variables:Man kan und sig over at træninsgruppen blev forværret efter 4 uge. Man skulle måske hanve ladet dem passsig selv. er er et ptoblem med iagnostikken - inklusionskriterierne uklare og ikke i oveensstemelse med sædvanlig praks.
Comment: No sample size calculation, very small groups (3 x 13), those not tolerating traction at first visit were excluded, baseline differences not accounted for in the analyses. Comparison treatment not described.No trial registration
Comment: No other sources of bias detected
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