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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00463970
First Posted: April 20, 2007
Last Update Posted: February 23, 2017
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.
Collaborators:
The Research Council of Norway
University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
Uni Research
  Purpose
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 Intervention Phase
Chronic Low Back Pain Behavioral: Brief Intervention Behavioral: Cognitive Behavioural Therapy Dietary Supplement: Seal oil Dietary Supplement: Soy oil Phase 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Uni Research:

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

Secondary Outcome Measures:
  • Health complaints [ Time Frame: 2008-2010 ]
  • Psychopathology [ Time Frame: 2008-2010 ]
  • Cortisol curves [ Time Frame: 2008-2010 ]
  • Function [ Time Frame: 2008-2010 ]

Enrollment: 414
Study Start Date: February 2008
Study Completion Date: August 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00463970


Locations
Norway
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
Investigators
Principal Investigator: Hege R Eriksen, Professor Unifob health, University of Bergen
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT00463970     History of Changes
Other Study ID Numbers: CINS2007
First Submitted: April 18, 2007
First Posted: April 20, 2007
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms