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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| University of Bergen | OTHER |
| Haukeland University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Brief Intervention |
|
| 2 | Experimental | Cognitive Behavioural Therapy |
|
| 3 | Experimental | Seal oil |
|
| 4 | Placebo Comparator | Soy oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Intervention | Behavioral | Physical examination, education and follow up by a physiotherapist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sickness leave | 2008-2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Health complaints | 2008-2010 | |
| Psychopathology | 2008-2010 | |
| Cortisol curves |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hege R Eriksen, Professor | Unifob health, University of Bergen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uni Research Health | Bergen | 5015 | Norway | |||
| Torill H Tveito |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21736730 | Result | 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. | |
| 21592832 |
| Label | URL |
|---|---|
| Study website | View source |
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| ID | Term |
|---|---|
| D003419 | Crisis Intervention |
| D015928 | Cognitive Behavioral Therapy |
| D000091942 | Cognitive Training |
| D019015 | Geologic Sediments |
| D019587 | Dietary Supplements |
| D013024 | Soybean Oil |
| D010938 | Plant Oils |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D001521 | Behavior Therapy |
| D000066530 | Neurological Rehabilitation |
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| Cognitive Behavioural Therapy | Behavioral | 7 sessions of CBT over a period of 2 months, included a booster session after 3 months |
|
|
| Seal oil | Dietary Supplement | 20 capsules per day for 3 months |
|
|
| Soy oil | Dietary Supplement | 20 capsules per day for 3 months |
|
|
| 2008-2010 |
| Function | 2008-2010 |
| Bergen |
| Norway |
| 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. |
| 26001959 | 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. |
| 27760062 | 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. |
| 27855684 | Derived | 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. |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D055593 | Geological Phenomena |
| D055585 | Physical Phenomena |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005224 | Fats, Unsaturated |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |