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

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
University of Bergen
Haukeland University Hospital
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT00463970
First received: April 18, 2007
Last updated: October 21, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health complaints [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
  • Psychopathology [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
  • Cortisol curves [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
  • Function [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463970

Locations
Norway
Torill H Tveito
Bergen, Norway
Unifob health, University of Bergen
Bergen, Norway, 5015
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

Publications:
Additional 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
Study First Received: April 18, 2007
Last Updated: October 21, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014