Evidence map›Paper›PMID 21736730›Full record

Trial reportBMC musculoskeletal disorders2011

Protocol for the Cognitive Interventions and Nutritional Supplements (CINS) trial: a randomized controlled multicenter trial of a brief intervention (BI) versus a BI plus cognitive behavioral treatment (CBT) versus nutritional supplements for patients with long-lasting muscle and back pain.

Silje E Reme, Torill H Tveito, Trudie Chalder, Tormod Bjørkkjaer, Aage Indahl, Jens I Brox, Egil Fors, Eli M Hagen, Hege R Eriksen

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00463970 (A Randomized Controlled Multicentre Trial of a Brief Intervention), which is not on this map. Cited by 11 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 4 pooled it
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00463970 phase1completednot on this map

A Randomized Controlled Multicentre Trial of a Brief Intervention (BI) Versus a BI Plus Cognitive Behavioural Treatment (CBT) Versus Nutritional Supplementation for Patients With Long-lasting Back Pain.

TypeinterventionalSponsorNORCE Norwegian Research Centre ASRan2008 to 2012Enrolled414ConditionsChronic Low Back PainArmsBrief Intervention, Cognitive Behavioural Therapy, Seal oil, Soy oil
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Workplace interventions to prevent work disability in workers on sick leave.The Cochrane database of systematic reviews · 2015
    Pooled it
  4. Herbal medicine for low-back pain.The Cochrane database of systematic reviews · 2014
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 3 countries.

Silje E RemeUni Health, Uni Research, Bergen, Norway.
Torill H Tveito
Trudie Chalder
Tormod Bjørkkjaer
Aage Indahl
Jens I Brox
Egil Fors
Eli M Hagen
Hege R Eriksen
University of Bergen · NOHarvard University · USInnlandet Hospital Trust · NOKing's College London · GBOslo University Hospital · NOSt Olav's University Hospital · NOUni Research (Norway) · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBrief intervention programs are clinically beneficial, and cost efficient treatments for low back pain, when offered at 8-12 weeks, compared with treatment as usual. However, about 30% of the patients do not return to work. The European Guidelines for treatment of chronic low back pain recommends Cognitive Behavioral Therapy (CBT), but conclude that further research is needed to evaluate the effectiveness of CBT for chronic low back pain. METHODS/

designThe aim of the multicenter CINS trial (Cognitive Interventions and Nutritional Supplements) is to compare the effectiveness of 4 different interventions; Brief Intervention, Brief Intervention and CBT, Brief Intervention and nutritional supplements of seal oil, and Brief Intervention and nutritional supplements of soy oil. All participants will be randomly assigned to the interventions. The nutritional supplements will be tested in a double blind design. 400 patients will be recruited from a population of chronic low back pain patients that have been sick listed for 2-10 months. Four outpatient clinics, located in different parts of Norway, will participate in recruitment and treatment of the patients.The Brief Intervention is a one session cognitive, clinical examination program based on a non-injury model, where return to normal activity and work is the main goal, and is followed by two booster sessions. The CBT is a tailored treatment involving 7 sessions, following a detailed manual. The nutritional supplements consist of a dosage of 10 grams of either soy or seal oil (capsules) per day for 3 months, administered in a double blind design. All patients will be followed up with questionnaires after 3, 6 and 12 months, while sick leave data will be collected up to at least 24 months after randomization. The primary outcome of the study is sick leave and will be based on register data from the National Insurance Administration. Secondary outcomes include self-reported data on disability, pain, and psychological variables.

conclusionsTo our knowledge, the CINS trial will be the largest, randomized trial of psychological and nutritional interventions for chronic low back pain patients to date. It will provide important information regarding the effectiveness of CBT and seal oil for chronic low back pain patients.

trial registrationhttp://www.clinicaltrials.gov, with registration number NCT00463970.

Indexed as

AdultChronic DiseaseCognitive Behavioral TherapyDietary Fats, UnsaturatedDietary SupplementsDouble-Blind MethodFatty Acids, MonounsaturatedFemaleHumansLow Back PainMaleMiddle AgedMuscular DiseasesResearch DesignSoybean OilYoung AdultDietary Fats, UnsaturatedFatty Acids, MonounsaturatedSoybean Oil

Identifiers

PMID21736730
PMCPMC3146910
OpenAlexW2120879707

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.