NCT00463970

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 414 (actual)
• Sponsor: NORCE Norwegian Research Centre AS · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
BEHAVIORAL	Brief Intervention	Physical examination, education and follow up by a physiotherapist
BEHAVIORAL	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
DIETARY_SUPPLEMENT	Soy oil	20 capsules per day for 3 months

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-08-01
• Completion: 2012-08-01
• First posted: 2007-04-20
• Last updated: 2017-02-23

Locations

2 sites across 1 country: Norway