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.
| Registry | NCT00463970, acronym CINS |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 414 (Actual) |
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| Sponsor | NORCE Norwegian Research Centre AS (Other); collaborators: The Research Council of Norway, University of Bergen, Haukeland University Hospital |
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| Conditions | Chronic Low Back Pain |
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| Interventions | Brief Intervention, Cognitive Behavioural Therapy, Seal oil, Soy oil (Behavioral, dietary supplement) |
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| Dates | start 2008-02-01, primary completion 2010-08-01, completion 2012-08-01, first posted 2007-04-20, last updated 2017-02-23 |
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| Locations | 2 sites in Norway |
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Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Low Back Pain All trials of Brief Intervention All trials of Cognitive Behavioural Therapy
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| 1 | Active comparator | Behavioral: Brief Intervention | Brief Intervention |
| 2 | Experimental | Behavioral: Cognitive Behavioural Therapy | Cognitive Behavioural Therapy |
| 3 | Experimental | Dietary Supplement: Seal oil | Seal oil |
| 4 | Placebo comparator | Dietary Supplement: Soy oil | Soy oil |
- Brief Intervention (Behavioral), also known as Brief Education, Light mobilization treatment: Physical examination, education and follow up by a physiotherapist
- Cognitive Behavioural Therapy (Behavioral), also known as Cognitive behavioral treatment, Cognitive rehabilitation: 7 sessions of CBT over a period of 2 months, included a booster session after 3 months
- Seal oil (Dietary supplement), also known as Marine oil, Nutritional supplement: 20 capsules per day for 3 months
- Soy oil (Dietary supplement), also known as Vegetable oil, Nutritional supplement: 20 capsules per day for 3 months
+Outcome measures
Primary outcomes
- Sickness leave [2008-2020]
Secondary outcomes
- Health complaints [2008-2010]
- Psychopathology [2008-2010]
- Cortisol curves [2008-2010]
- Function [2008-2010]
+Eligibility
Sex: All, ages: 20 Years to 60 Years
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
+Locations (2)
| Facility | City | Country | Status |
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| Uni Research Health | Bergen | Norway | |
| Torill H Tveito | Bergen | Norway | |
+Publications
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: 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
- Results publication: Rosenblom MF, Jacobsen HB, Reme SE. Ready or Not? Applying the Transtheoretical Model of Change on Return-to-Work Following CBT for Chronic Low Back Pain. J Occup Rehabil. 2026 Jul 17. doi: 10.1007/s10926-026-10432-5. Online ahead of print. PMID 42469553
- Results publication: 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
+Investigators