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Completed

NCT Number: NCT00463970

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

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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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Torill H Tveito, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief intervention

Behavioral

Physical examination, education and follow up by a physiotherapist

Other names: Brief Education, Light mobilization treatment

Cognitive Behavioural Therapy

Behavioral

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

Other names: Cognitive behavioral treatment, Cognitive rehabilitation

Seal oil

Dietary Supplement

20 capsules per day for 3 months

Other names: Marine oil, Nutritional supplement

Soy oil

Dietary Supplement

20 capsules per day for 3 months

Other names: Vegetable oil, Nutritional supplement

Primary outcomes

  1. Sickness leave

    Time frame: 2008-2020

Secondary outcomes

  1. Health complaints

    Time frame: 2008-2010

  2. Psychopathology

    Time frame: 2008-2010

  3. Cortisol curves

    Time frame: 2008-2010

  4. Function

    Time frame: 2008-2010

Sponsors and collaborators

Lead sponsor

NORCE Norwegian Research Centre AS

Other

Collaborators

  • Haukeland University Hospital
  • The Research Council of Norway
  • University of Bergen

Registry information

Official study 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.

Acronym: CINS

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Apr 20, 2007
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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