Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain (CINS)
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Brief Intervention
Cognitive Behavioural Therapy
Seal oil
Soy oil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Brief cognitive intervention, Cognitive behavior therapy, Seal oil
Eligibility 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
Sites / Locations
- Uni Research Health
- Torill H Tveito
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Brief Intervention
Cognitive Behavioural Therapy
Seal oil
Soy oil
Outcomes
Primary Outcome Measures
Sickness leave
Secondary Outcome Measures
Health complaints
Psychopathology
Cortisol curves
Function
Full Information
NCT ID
NCT00463970
First Posted
April 18, 2007
Last Updated
February 20, 2017
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
The Research Council of Norway, University of Bergen, Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00463970
Brief Title
Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain
Acronym
CINS
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
The Research Council of Norway, University of Bergen, Haukeland University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic low back pain, Brief cognitive intervention, Cognitive behavior therapy, Seal oil
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
414 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Brief Intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Cognitive Behavioural Therapy
Arm Title
3
Arm Type
Experimental
Arm Description
Seal oil
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Soy oil
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Other Intervention Name(s)
Brief Education, Light mobilization treatment
Intervention Description
Physical examination, education and follow up by a physiotherapist
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Other Intervention Name(s)
Cognitive behavioral treatment, Cognitive rehabilitation
Intervention Description
7 sessions of CBT over a period of 2 months, included a booster session after 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Seal oil
Other Intervention Name(s)
Marine oil, Nutritional supplement
Intervention Description
20 capsules per day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy oil
Other Intervention Name(s)
Vegetable oil, Nutritional supplement
Intervention Description
20 capsules per day for 3 months
Primary Outcome Measure Information:
Title
Sickness leave
Time Frame
2008-2020
Secondary Outcome Measure Information:
Title
Health complaints
Time Frame
2008-2010
Title
Psychopathology
Time Frame
2008-2010
Title
Cortisol curves
Time Frame
2008-2010
Title
Function
Time Frame
2008-2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hege R Eriksen, Professor
Organizational Affiliation
Unifob health, University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uni Research Health
City
Bergen
ZIP/Postal Code
5015
Country
Norway
Facility Name
Torill H Tveito
City
Bergen
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
21736730
Citation
Reme SE, Tveito TH, Chalder T, Bjorkkjaer 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. doi: 10.1186/1471-2474-12-152.
Results Reference
result
PubMed Identifier
21592832
Citation
Reme SE, Tangen T, Moe T, Eriksen HR. Prevalence of psychiatric disorders in sick listed chronic low back pain patients. Eur J Pain. 2011 Nov;15(10):1075-80. doi: 10.1016/j.ejpain.2011.04.012. Epub 2011 May 17.
Results Reference
result
PubMed Identifier
26001959
Citation
Harris A, Endresen Reme S, Tangen T, Hansen AM, Helene Garde A, Eriksen HR. Diurnal cortisol rhythm: Associated with anxiety and depression, or just an indication of lack of energy? Psychiatry Res. 2015 Aug 15;228(2):209-15. doi: 10.1016/j.psychres.2015.04.006. Epub 2015 Apr 24.
Results Reference
result
PubMed Identifier
27760062
Citation
Reme SE, Tveito TH, Harris A, Lie SA, Grasdal A, Indahl A, Brox JI, Tangen T, Hagen EM, Gismervik S, Odegard A, Fr Yland L, Fors EA, Chalder T, Eriksen HR. Cognitive Interventions and Nutritional Supplements (The CINS Trial): A Randomized Controlled, Multicenter Trial Comparing a Brief Intervention With Additional Cognitive Behavioral Therapy, Seal Oil, and Soy Oil for Sick-Listed Low Back Pain Patients. Spine (Phila Pa 1976). 2016 Oct 15;41(20):1557-1564. doi: 10.1097/BRS.0000000000001596.
Results Reference
result
PubMed Identifier
27855684
Citation
Opsahl J, Eriksen HR, Tveito TH. Do expectancies of return to work and Job satisfaction predict actual return to work in workers with long lasting LBP? BMC Musculoskelet Disord. 2016 Nov 17;17(1):481. doi: 10.1186/s12891-016-1314-2.
Results Reference
derived
Links:
URL
http://uni.no/nb/uni-helse/stress-helse-og-rehabilitering/ryggstudien-cins/
Description
Study website
Learn more about this trial
Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain
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