Clinical trial NCT00463970: Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Low Back Pain
Keywords: Chronic low back pain
Brief cognitive intervention
Cognitive behavior therapy
Seal oil
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Bergen
name: Haukeland University Hospital
First posted: 2007-04-20
Enrollment: 414
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sickness leave
timeFrame: 2008-2020
Secondary outcomes:
measure: Health complaints
timeFrame: 2008-2010
measure: Psychopathology
timeFrame: 2008-2010
measure: Cortisol curves
timeFrame: 2008-2010
measure: Function
timeFrame: 2008-2010
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Uni Research Health
city: Bergen
country: Norway
facility: Torill H Tveito
Study officials:
affiliation: Unifob health, University of Bergen
name: Hege R Eriksen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reme SE, Tveito TH, Chalder T, Bjorkkjaer T, Indahl A, Brox JI, Fors E, Hagen EM, Eriksen HR. 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. BMC Musculoskelet Disord. 2011 Jul 7;12:152. doi: 10.1186/1471-2474-12-152.
citation: Reme SE, Tangen T, Moe T, Eriksen HR. Prevalence of psychiatric disorders in sick listed chronic low back pain patients. Eur J Pain. 2011 Nov;15(10):1075-80. doi: 10.1016/j.ejpain.2011.04.012. Epub 2011 May 17.
citation: Harris A, Endresen Reme S, Tangen T, Hansen AM, Helene Garde A, Eriksen HR. Diurnal cortisol rhythm: Associated with anxiety and depression, or just an indication of lack of energy? Psychiatry Res. 2015 Aug 15;228(2):209-15. doi: 10.1016/j.psychres.2015.04.006. Epub 2015 Apr 24.
citation: Reme SE, Tveito TH, Harris A, Lie SA, Grasdal A, Indahl A, Brox JI, Tangen T, Hagen EM, Gismervik S, Odegard A, Fr Yland L, Fors EA, Chalder T, Eriksen HR. Cognitive Interventions and Nutritional Supplements (The CINS Trial): A Randomized Controlled, Multicenter Trial Comparing a Brief Intervention With Additional Cognitive Behavioral Therapy, Seal Oil, and Soy Oil for Sick-Listed Low Back Pain Patients. Spine (Phila Pa 1976). 2016 Oct 15;41(20):1557-1564. doi: 10.1097/BRS.0000000000001596.
citation: Opsahl J, Eriksen HR, Tveito TH. Do expectancies of return to work and Job satisfaction predict actual return to work in workers with long lasting LBP? BMC Musculoskelet Disord. 2016 Nov 17;17(1):481. doi: 10.1186/s12891-016-1314-2.