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

Phase 1

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Dietary Supplement: Seal oil; Dietary Supplement: Soy oil; Behavioral: Brief Intervention; Behavioral: Cognitive Behavioural Therapy

• Registration Number: NCT00463970
• Lead Sponsor: NORCE Norwegian Research Centre AS

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.

Study Timeline

• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Study Start: 2008-02
• Primary Completion: 2010-08
• Study Completion: 2012-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Seal oil	Seal oil
4	Soy oil	Soy oil
1	Brief Intervention	Brief Intervention
2	Cognitive Behavioural Therapy	Cognitive Behavioural Therapy

Primary Outcome Measures

Name	Time	Method
Sickness leave	2008-2020

Secondary Outcome Measures

Name	Time	Method
Cortisol curves	2008-2010
Function	2008-2010
Health complaints	2008-2010
Psychopathology	2008-2010

Trial Locations

Locations (2)

Uni Research Health; 🇳🇴 Bergen, Norway

Torill H Tveito; 🇳🇴 Bergen, Norway