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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Brief Intervention
* Behavioral: Cognitive Behavioural Therapy
* Dietary Supplement: Seal oil
* Dietary Supplement: Soy oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Brief Intervention | Behavioral: Brief Intervention<br>* Physical examination, education and follow up by a physiotherapist<br>* Other names: Light mobilization treatment;|
| Experimental: 2<br>Cognitive Behavioural Therapy | Behavioral: Cognitive Behavioural Therapy<br>* 7 sessions of CBT over a period of 2 months, included a booster session after 3 months<br>* Other names: Cognitive rehabilitation;|
| Experimental: 3<br>Seal oil | Dietary Supplement: Seal oil<br>* 20 capsules per day for 3 months<br>* Other names: Nutritional supplement;|
| Placebo Comparator: 4<br>Soy oil | Dietary Supplement: Soy oil<br>* 20 capsules per day for 3 months<br>* Other names: Nutritional supplement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sickness leave |  | 2008-2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health complaints |  | 2008-2010 | 
| Psychopathology |  | 2008-2010 | 
| Cortisol curves |  | 2008-2010 | 
| Function |  | 2008-2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Brief cognitive intervention, Cognitive behavior therapy, Seal oil