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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00463970
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : February 23, 2017
The Research Council of Norway
University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
Uni Research

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Brief Intervention Behavioral: Cognitive Behavioural Therapy Dietary Supplement: Seal oil Dietary Supplement: Soy oil Phase 1

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  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : February 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 behavioral treatment
  • Cognitive rehabilitation
Experimental: 3
Seal oil
Dietary Supplement: Seal oil
20 capsules per day for 3 months
Other Names:
  • Marine oil
  • Nutritional supplement
Placebo Comparator: 4
Soy oil
Dietary Supplement: Soy oil
20 capsules per day for 3 months
Other Names:
  • Vegetable oil
  • Nutritional supplement

Primary Outcome Measures :
  1. Sickness leave [ Time Frame: 2008-2020 ]

Secondary Outcome Measures :
  1. Health complaints [ Time Frame: 2008-2010 ]
  2. Psychopathology [ Time Frame: 2008-2010 ]
  3. Cortisol curves [ Time Frame: 2008-2010 ]
  4. Function [ Time Frame: 2008-2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00463970

Uni Research Health
Bergen, Norway, 5015
Torill H Tveito
Bergen, Norway
Sponsors and Collaborators
Uni Research
The Research Council of Norway
University of Bergen
Haukeland University Hospital
Principal Investigator: Hege R Eriksen, Professor Unifob health, University of Bergen

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Uni Research Identifier: NCT00463970     History of Changes
Other Study ID Numbers: CINS2007
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Uni Research:
Chronic low back pain
Brief cognitive intervention
Cognitive behavior therapy
Seal oil

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms