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

NCT00463970 | Completed Phase 1 DMC

• 1 other identifier: CINS2007
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low Back Pain

Keywords

Chronic low back pain; Brief cognitive intervention; Cognitive behavior therapy; Seal oil

Outcome Measures

Primary Outcomes (1)

• Sickness leave

  2008-2020

Secondary Outcomes (4)

• Health complaints

  2008-2010

• Psychopathology

  2008-2010

• Cortisol curves

  2008-2010

• Function

  2008-2010

Study Arms (4)

1

ACTIVE COMPARATOR

Brief Intervention

Behavioral: Brief Intervention

2

EXPERIMENTAL

Cognitive Behavioural Therapy

Behavioral: Cognitive Behavioural Therapy

3

EXPERIMENTAL

Seal oil

Dietary Supplement: Seal oil

4

PLACEBO COMPARATOR

Soy oil

Dietary Supplement: Soy oil

Interventions

Brief Intervention BEHAVIORAL

Physical examination, education and follow up by a physiotherapist

Also known as: Brief Education, Light mobilization treatment

1

Cognitive Behavioural Therapy BEHAVIORAL

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

Also known as: Cognitive behavioral treatment, Cognitive rehabilitation

2

Seal oil DIETARY_SUPPLEMENT

20 capsules per day for 3 months

Also known as: Marine oil, Nutritional supplement

3

Soy oil DIETARY_SUPPLEMENT

20 capsules per day for 3 months

Also known as: Vegetable oil, Nutritional supplement

4

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients sicklisted 2-10 months for low back pain
• The following diagnosis are included: L02, L03, L84 and L86

You may not qualify if:

• 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

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead
• The Research Council of Norway: collaborator
• University of Bergen: collaborator
• Haukeland University Hospital: collaborator

Study Sites (2)

Uni Research Health

Bergen, 5015, Norway

Location

Torill H Tveito

Bergen, Norway

Location

Related Publications (5)

• 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.

  PMID: 21736730 RESULT

• 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.

  PMID: 21592832 RESULT

• 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.

  PMID: 26001959 RESULT

• 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.

  PMID: 27760062 RESULT

• 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.

  PMID: 27855684 DERIVED

Related Links

• Study website

MeSH Terms

Interventions

Crisis Intervention; Cognitive Behavioral Therapy; Cognitive Training; Geologic Sediments; Dietary Supplements; Soybean Oil; Plant Oils

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Geological Phenomena; Physical Phenomena; Ecological and Environmental Phenomena; Biological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Hege R Eriksen, Professor

  Unifob health, University of Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: February 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2012
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

NO (2)