Chronic Low Back PainPhase 1CINSNCT00463970
Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain
A Phase 1 study testing Brief Intervention, Cognitive Behavioural Therapy and Seal oil in people with Chronic Low Back Pain, run by NORCE Norwegian Research Centre AS at 2 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Brief Intervention, Cognitive Behavioural Therapy and Seal oil
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 414 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2008to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients sicklisted 2-10 months for low back pain
- The following diagnosis are included: L02, L03, L84 and L86
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official 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.
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Brief Intervention, Cognitive Behavioural Therapy, Seal oil, Soy oil
- Keywords
- Chronic low back pain, Brief cognitive intervention, Cognitive behavior therapy, Seal oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
Also called Brief Education, Light mobilization treatment
Physical examination, education and follow up by a physiotherapist
Cognitive Behavioural TherapyBehavioural
Also called Cognitive behavioral treatment, Cognitive rehabilitation
7 sessions of CBT over a period of 2 months, included a booster session after 3 months
Seal oilDietary supplement
Also called Marine oil, Nutritional supplement
20 capsules per day for 3 months
Soy oilDietary supplement
Also called Vegetable oil, Nutritional supplement
20 capsules per day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Brief Intervention Receives: Behavioral: Brief Intervention |
| 2 | Experimental | Cognitive Behavioural Therapy Receives: Behavioral: Cognitive Behavioural Therapy |
| 3 | Experimental | Seal oil Receives: Dietary Supplement: Seal oil |
| 4 | Placebo comparator | Soy oil Receives: Dietary Supplement: Soy oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sickness leave
Measured: 2008-2020
Secondary outcomes (4)
Health complaints
Measured: 2008-2010
Psychopathology
Measured: 2008-2010
Cortisol curves
Measured: 2008-2010
Function
Measured: 2008-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startFeb 2008
- Primary completionAug 2010
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University of Bergen, Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Hege R Eriksen, Professor, Principal investigator, Unifob health, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463970
- Sponsor's protocol ID
- CINS2007
- Acronym
- CINS
- Status last verified
- Feb 2017
- First submitted
- 18 Apr 2007
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21736730Reme 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.
PubMed 21592832Harris 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.
PubMed 26001959Reme 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.
PubMed 27760062Rosenblom 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.
PubMed 42469553Opsahl 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.
PubMed 27855684
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT00463970
- Acronym / sponsor ID
- CINS / CINS2007
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic low back pain, Brief cognitive intervention, Cognitive behavior therapy, Seal oil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Bergen, Haukeland University Hospital
- Study start
- Feb 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Brief InterventionBrief Intervention |
| 2 | Experimental | Behavioral: Cognitive Behavioural TherapyCognitive Behavioural Therapy |
| 3 | Experimental | Dietary Supplement: Seal oilSeal oil |
| 4 | Placebo comparator | Dietary Supplement: Soy oilSoy oil |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients sicklisted 2-10 months for low back pain
- The following diagnosis are included: L02, L03, L84 and L86
Key exclusion criteria (7 listed)
- Being off the sick list
- Pregnancy
- Osteoporosis
- Cancer
- L diagnoses suggesting recent low back pain trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionAlso: Brief Education, Light mobilization treatmentPhysical examination, education and follow up by a physiotherapist | Behavioural | 1 |
| Cognitive Behavioural TherapyAlso: Cognitive behavioral treatment, Cognitive rehabilitation7 sessions of CBT over a period of 2 months, included a booster session after 3 months | Behavioural | 2 |
| Seal oilAlso: Marine oil, Nutritional supplement20 capsules per day for 3 months | Dietary supplement | 3 |
| Soy oilAlso: Vegetable oil, Nutritional supplement20 capsules per day for 3 months | Dietary supplement | 4 |
Primary outcome
Sickness leave
Time frame: 2008-2020
4 secondary outcomes
Health complaints
Time frame: 2008-2010
Psychopathology
Time frame: 2008-2010
Cortisol curves
Time frame: 2008-2010
Function
Time frame: 2008-2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Results publication: PubMed 21736730Reme 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.
- Results publication: PubMed 21592832Reme 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.
- Results publication: PubMed 26001959Harris 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.
- Results publication: PubMed 27760062Reme 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.
- Derived from this study: PubMed 42469553Rosenblom 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.
- Derived from this study: PubMed 27855684Opsahl 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.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hege R Eriksen, Professor principal investigator
Unifob health, University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brief Intervention, Cognitive Behavioural Therapy and Seal oil in people with Chronic Low Back Pain, run by NORCE Norwegian Research Centre AS at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sickness leave (time frame: 2008-2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463970, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.