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Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00463970
Acronym
CINS
Enrollment
414
Registered
2007-04-20
Start date
2008-02-29
Completion date
2012-08-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain, Brief cognitive intervention, Cognitive behavior therapy, Seal oil

Brief summary

CINS is a large multicentre study which aims to test out the effect of 4 different interventions, namely a brief cognitive intervention (BI), a more extensive cognitive behavioural intervention (CBT), and 2 different nutritional supplementations (seal oil and soy oil) in a population of chronic low back pain patients sicklisted for 2-10 months.

Detailed description

The treatment principles for low back pain, and also other types of non-specific muscle pain, have changed dramatically over the last 10 to 15 years; from traditional treatment like bed rest and inactivity to more active treatment strategies (the back pain revolution; Waddell et al 1997). Norwegian research has been in the forefront, particularly in demonstrating the clinical and cost effective brief interventions (BI) (Indahl et al., 1995, 1998; Hagen et al 2000, 2004, Brox et al 2003, Storheim et al 2003). However, about 30% of the patients do not recover or return to normal social and working life. The aim of this study is therefore to see if a longer cognitive behavioural intervention (CBT) has an additional benefit to BI, and to compare this with a potentially beneficial dietary supplement.

Interventions

BEHAVIORALBrief Intervention

Physical examination, education and follow up by a physiotherapist

BEHAVIORALCognitive Behavioural Therapy

7 sessions of CBT over a period of 2 months, included a booster session after 3 months

DIETARY_SUPPLEMENTSeal oil

20 capsules per day for 3 months

DIETARY_SUPPLEMENTSoy oil

20 capsules per day for 3 months

Sponsors

The Research Council of Norway
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
NORCE Norwegian Research Centre AS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients sicklisted 2-10 months for low back pain * The following diagnosis are included: L02, L03, L84 and L86

Exclusion criteria

* Being off the sick list * Pregnancy * Osteoporosis * Cancer * L diagnoses suggesting recent low back pain trauma * Specific spinal or other injuries which may account for the current back pain * Serious psychiatric pathology

Design outcomes

Primary

MeasureTime frame
Sickness leave2008-2020

Secondary

MeasureTime frame
Health complaints2008-2010
Psychopathology2008-2010
Cortisol curves2008-2010
Function2008-2010

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 19, 2026