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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-08-31

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.

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Brief Intervention

Group Type ACTIVE_COMPARATOR

Brief Intervention

Intervention Type BEHAVIORAL

Physical examination, education and follow up by a physiotherapist

2

Cognitive Behavioural Therapy

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy

Intervention Type BEHAVIORAL

7 sessions of CBT over a period of 2 months, included a booster session after 3 months

3

Seal oil

Group Type EXPERIMENTAL

Seal oil

Intervention Type DIETARY_SUPPLEMENT

20 capsules per day for 3 months

4

Soy oil

Group Type PLACEBO_COMPARATOR

Soy oil

Intervention Type DIETARY_SUPPLEMENT

20 capsules per day for 3 months

Interventions

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Brief Intervention

Physical examination, education and follow up by a physiotherapist

Intervention Type BEHAVIORAL

Cognitive Behavioural Therapy

7 sessions of CBT over a period of 2 months, included a booster session after 3 months

Intervention Type BEHAVIORAL

Seal oil

20 capsules per day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Soy oil

20 capsules per day for 3 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Brief Education Light mobilization treatment Cognitive behavioral treatment Cognitive rehabilitation Marine oil Nutritional supplement Vegetable oil Nutritional supplement

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No