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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Uni Research.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

The Research Council of Norway

University of Bergen

Haukeland University Hospital

Information provided by:

Uni Research

ClinicalTrials.gov Identifier:

NCT00463970

First received: April 18, 2007

Last updated: February 17, 2011

Last verified: January 2010

History of Changes

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:

MedlinePlus related topics: Back Pain Dietary Supplements

Drug Information available for: Soybean oil

U.S. FDA Resources

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 ]

Estimated Enrollment:	600
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2012
Estimated 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 Treatment	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

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

Locations

Norway
Unifob health, University of Bergen
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

Publications:

Indahl A, Haldorsen EH, Holm S, Reikeras O, Ursin H. Five-year follow-up study of a controlled clinical trial using light mobilization and an informative approach to low back pain. Spine. 1998 Dec 1;23(23):2625-30.

Indahl A, Velund L, Reikeraas O. Good prognosis for low back pain when left untampered. A randomized clinical trial. Spine. 1995 Feb 15;20(4):473-7.

Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine. 2003 Sep 1;28(17):1913-21.

Hagen EM, Eriksen HR, Ursin H. Does early intervention with a light mobilization program reduce long-term sick leave for low back pain? Spine. 2000 Aug 1;25(15):1973-6.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reme SE, Tveito TH, Chalder T, Bjørkkjaer T, Indahl A, Brox JI, Fors E, Hagen EM, Eriksen HR. Protocol for the Cognitive Interventions and Nutritional Supplements (CINS) trial: a randomized controlled multicenter trial of a brief intervention (BI) versus a BI plus cognitive behavioral treatment (CBT) versus nutritional supplements for patients with long-lasting muscle and back pain. BMC Musculoskelet Disord. 2011 Jul 7;12:152.

Responsible Party:	Hege Randi Eriksen, Research Director, Unifob Health
ClinicalTrials.gov Identifier:	NCT00463970 History of Changes
Other Study ID Numbers:	CINS2007
Study First Received:	April 18, 2007
Last Updated:	February 17, 2011
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
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013

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