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
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

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

External Links

•   Study website