[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label: YES
Cluster RCT:
Baseline Characteristics
Intervention + usual care
comparison (home exercise/ usual care
other intervention (MDT)
Included criteria: age 21 years or older;BRLP based on Quebec Task Force on Spinal Disorders classifications 2, 3, 4, or 6 (radiating pain into the proximal or distal part of the lower extremity, with or without neurologic signs); BRLP severity of 3 or greater (scale of 0 to 10); a current episode of 4 weeks or more; and a stableprescription medication plan in the previous month.
Excluded criteria: Quebec Task Force on Spinal Disordersclassifications of 1, 5, 7, 8, 9, 10, and 11 (pain without radiation into the lower extremities, progressive neurologic deficits, the cauda equina syndrome, spinal fracture, spinal stenosis, surgical lumbar spine fusion, several incidents of lumbar spine surgery, chronic pain syndrome,visceral diseases, compression fractures or metastases, blood clotting disorders, severe osteoporosis, and inflammatory or destructive tissue changes of the spine). Patients couldnot be receiving ongoing treatment of leg pain or LBP; be pregnant or nursing; have current or pending litigation for worker’s compensation, disability, or personal injury; be unable to read or comprehend English; or have evidence of substance abuse.
Intervention Characteristics
Intervention + usual care
comparison (home exercise/ usual care
other intervention (MDT)
bensmerte
rygsmerte
funktionsevne
arbejdsevene (andel tilbage på arbejde op til 12 mdr)
smertehåndtering
bensmerte
rygsmerte
funktionsevne
arbejdsevne (dage sygemeldt op til 6 måneder)
andel tilbage på arbejde (12 mdr)
neurologiske udfald forværring
drop out
opereret (12 mdr)
Sponsorship source: By the Health Resources and Services Administration, U.S. Department of Health and Human Services (grant R18HP07638).
Country: United States
Setting: Forskningsklinikker på kirorpaktiske læreranstalter
Comments:
Authors name: Gert Bronfort
Institution: Center for Spirituality & Healing, University of Minnesota
Email: bronf003 @umn.edu
Address: MMC 505, 425 DelawareStreet Southeast, Minneapolis, MN 55455.
Alice Kongsted on 10/08/2015 19:38
Select
jeg er i tvivl om vi holdt fast i at der skal være neurologiske udfald, men gik ud fra at vi gjorde det da jeg ekskluderde
Birgitte Holm Petersen on 10/08/2015 20:15
Select
Vi kan godt nøjes med bensmerter i radikulært mønster, og dem er der en del af
Alice Kongsted on 26/08/2015 01:16
Continuous Outcomes
Global Improvement også rapporteret
Birgitte Holm Petersen on 27/08/2015 15:45
Continuous Outcomes
long term outcome er 12 måneder
Birgitte Holm Petersen on 27/08/2015 16:09
Adverse Outcomes
der er detaljeret rapportering af adverse events. Her angivet antal som har rapporteret een eller flere.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label: YES
Cluster RCT:
Baseline Characteristics
Intervention + usual care
comparison (home exercise/ usual care
other intervention (MDT)
Included criteria: 18–65-year-old employed people with current non-specific LBP with or without radiating pain to one or both lower legs. The back pain episode could be acute to chronic, the first or recurrent.
Excluded criteria: Pregnancy, low back surgery less than 2 months previously, and “red flags” that indicate serious spinal pathology
Intervention Characteristics
Intervention + usual care
comparison (home exercise/ usual care
other intervention (MDT)
bensmerte
rygsmerte
funktionsevne
arbejdsevene (andel tilbage på arbejde op til 12 mdr)
smertehåndtering
bensmerte
rygsmerte
funktionsevne
arbejdsevne (dage sygemeldt op til 6 måneder)
andel tilbage på arbejde (12 mdr)
neurologiske udfald forværring
drop out
opereret (12 mdr)
Sponsorship source: not declared
Country: Finland
Setting: Occupational health care centers
Comments: Adgang til centrene ikke beskrevet
Authors name: Markku Paatelma
Institution: Department of Health Sciences, University of Jyväskylä
Email: markku.paatelma@tcr.fi
Address: Härkälahdenkuja 9,FI-00850 Helsinki, Finland
Birgitte Holm Petersen on 10/08/2015 20:17
Select
Designet er fint, men problemet er at det er en blandet patientgruppe, hvoraf kun en del har tegn på radikulopati
Alice Kongsted on 26/08/2015 19:31
Study Design
Intervention: OMTComparison: AdviceOther intevention: MDT
Alice Kongsted on 26/08/2015 19:44
Continuous Outcomes
3 mdr outcome er angivet under 'op til 12 uger'Lang tids outcome er 6 mdrs.
Wrong patient population
Wrong patient population
Wrong patient population
Wrong study design
Wrong study design
Wrong comparator
Wrong study design
Wrong study design
Wrong patient population
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Quote: "The allocation algorithm was pre- pared by the study statistician before enrollment,"
Judgement Comment: Randomization of the participants into the treatment groups was by a stack of sealed envelopes, numbered in an order prepared from a random number table.
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Outcomes er patientrapporterede så kriteriet er ikke relevant
Judgement Comment: Outcome measures, which included a battery of self-reported measures (use of healthcare services due to other problems and other back pain treatments) were assessed at 3-, 6-, and 12-month visits. The measurements were made by one research assistant and coded by another who was blinded to the patient’s group assignment.
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Quote: "complete description of all secondary outcome mea- sures is provided elsewhere (29). The measures reported in this article include LBP, disability measured with the mod- ified Roland–Morris Disability Questionnaire (48 –50), physical and mental health status using the Short Form-36 Health Survey (SF-36) (51, 52), patient satisfaction (53), global improvement (53), and frequency of medication use for back and leg pain in the past week (53)."
Judgement Comment: standard outcome measures, registrered protocol?
Judgement Comment: standard outcomes reported as recommend by CONSORT and the Cochrane back group
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Blinding af patienter og behandlere ikke mulig
Judgement Comment: Those providing and receiving treatment were not blinded to intervention
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: patients have had a highly varying period of symptoms
Judgement Comment: Confrontation bias - subjects in the advice only group only got one session with a physiotherapist while the other groups got 3 -7 sessions of supervised exercise/treatment Mixed patient group can disguise different responses to the treatments. Manglende sample size beregningVurderes at gruppeforskelle skulle være store for at kunne påvises
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Quote: "Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks."
Judgement Comment: intention to treat analysis and all patients enrolled accounted for
Quote: "The drop-out rate during the follow-up year ranged from 14% in the McKenzie method group, to 22% in the OMT group, to 30% in the advice-only group."
Judgement Comment: All outcome measures specified in the methods section were reported of in the results and drop out accounted for. Intention to treat analysis 3 mdr drop out: 4.5%/7.7%/22% (MT/MDT/Advice)6 mdr drop out: 11.1% /9.6%/27%
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Quote: "The allocation algorithm was pre- pared by the study statistician before enrollment, and its administration was concealed from study personnel."
Judgement Comment: cannot see how this was done