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NCT00463970 Clinical Trial

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

Chronic Low Back Pain Clinical Trial

— CINS  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00463970
Other study ID # CINS2007
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2007
Last updated February 20, 2017
Start date February 2008
Est. completion date August 2012

Study information
Verified date February 2017
Source Uni Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 414
Est. completion date August 2012
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Brief Intervention
Physical examination, education and follow up by a physiotherapist
• Cognitive Behavioural Therapy
7 sessions of CBT over a period of 2 months, included a booster session after 3 months
Dietary Supplement:
• Seal oil
20 capsules per day for 3 months
• Soy oil
20 capsules per day for 3 months

Locations
Country Name City State
Norway Torill H Tveito Bergen
Norway Uni Research Health Bergen

Sponsors (4)
Lead Sponsor Collaborator
Uni Research Haukeland University Hospital, The Research Council of Norway, University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Harris A, Endresen Reme S, Tangen T, Hansen ÅM, 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.2015.0 — View 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. — View Citation

Reme SE, Tveito TH, Chalder T, Bjørkkjaer 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 — View Citation

Reme SE, Tveito TH, Harris A, Lie SA, Grasdal A, Indahl A, Brox JI, Tangen T, Hagen EM, Gismervik S, Ødegård A, Fryland L, Fors EA, Chalder T, Eriksen HR. Cognitive Interventions and Nutritional Supplements (The CINS Trial): A Randomized Controlled, Multi — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Sickness leave 2008-2020
Secondary Health complaints 2008-2010
Secondary Psychopathology 2008-2010
Secondary Cortisol curves 2008-2010
Secondary Function 2008-2010
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