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

February 20, 2017 updated by: NORCE Norwegian Research Centre AS

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

414

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5015
        • Uni Research Health
      • Bergen, Norway
        • Torill H Tveito

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Brief Intervention
Behavioral: Brief Intervention
Physical examination, education and follow up by a physiotherapist
Other Names:
  • Brief Education
  • Light mobilization treatment
Experimental: 2
Cognitive Behavioural Therapy
Behavioral: Cognitive Behavioural Therapy
7 sessions of CBT over a period of 2 months, included a booster session after 3 months
Other Names:
  • Cognitive rehabilitation
  • Cognitive behavioral treatment
Experimental: 3
Seal oil
Dietary supplement: Seal oil
20 capsules per day for 3 months
Other Names:
  • Nutritional supplement
  • Marine oil
Placebo Comparator: 4
Soy oil
Dietary supplement: Soy oil
20 capsules per day for 3 months
Other Names:
  • Vegetable oil
  • Nutritional supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sickness leave
Time Frame: 2008-2020
2008-2020

Secondary Outcome Measures

Outcome Measure
Time Frame
Health complaints
Time Frame: 2008-2010
2008-2010
Psychopathology
Time Frame: 2008-2010
2008-2010
Cortisol curves
Time Frame: 2008-2010
2008-2010
Function
Time Frame: 2008-2010
2008-2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Collaborators

University of Bergen
The Research Council of Norway
Haukeland University Hospital

Investigators

  • Principal Investigator: Hege R Eriksen, Professor, Unifob health, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINS2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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