Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Oct 15;41(20):1557-1564.
doi: 10.1097/BRS.0000000000001596.

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

Silje E Reme  1   2   3 , Torill H Tveito  1   4 , Anette Harris  5 , Stein Atle Lie  6 , Astrid Grasdal  7 , Aage Indahl  5   8 , Jens Ivar Brox  2 , Tone Tangen  9 , Eli Molde Hagen  10 , Sigmund Gismervik  11   12 , Arit Ødegård  13 , Livar Fr Yland  14 , Egil A Fors  12   15 , Trudie Chalder  16 , Hege R Eriksen  1   17
Affiliations
Randomized Controlled Trial

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

Silje E Reme et al. Spine (Phila Pa 1976). .

Abstract

Study design: A randomized controlled trial.

Objective: The aim of this study was to evaluate whether a tailored and manualized cognitive behavior therapy (CBT) or nutritional supplements of seal oil and soy oil had any additional benefits over a brief cognitive intervention (BI) on return to work (RTW).

Summary of background data: Brief intervention programs are clinically beneficial and cost-effective for patients with low back pain (LBP). CBT is recommended for LBP, but evidence on RTW is lacking. Seal oil has previously been shown to have a possible effect on muscle pain, but no randomized controlled trials have so far been carried out in LBP patients.

Methods: Four hundred thirteen adults aged 18 to 60 years were included. Participants were sick-listed 2 to 10 months due to LBP. Main outcome was objectively ascertained work participation at 12-month follow-up. Participants were randomly assigned to BI (n = 100), BI and CBT (n = 103), BI and seal oil (n = 105), or BI and soy oil (n = 105). BI is a two-session cognitive, clinical examination program followed by two booster sessions, while the CBT program is a tailored, individual, seven-session manual-based treatment.

Results: At 12-month follow-up, 60% of the participants in the BI group, 50% in the BI and CBT group, 51% in the BI and seal oil group, and 53% in the BI and soy oil group showed reduced sick leave from baseline, and had either partly or fully RTW. The differences between the groups were not statistically significant (χ = 2.54, P = 0.47). There were no significant differences between the treatment groups at any of the other follow-up assessments either, except for a significantly lower sick leave rate in the BI group than the other groups during the first 3 months of follow-up (χ = 9.50, P = 0.02).

Conclusion: CBT and seal oil had no additional benefits over a brief cognitive intervention on sick leave. The brief cognitive intervention alone was superior in facilitating a fast RTW.

Level of evidence: 2.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Andersson GB. Epidemiological features of chronic low-back pain. Lancet 1999; 354:581–585.
    1. Waddell G, Burton AK. Occupational health guidelines for the management of low back pain at work: evidence review. Occup Med (Lond) 2001; 51:124–135.
    1. Vos T, Flaxman AD, Naghavi M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163–2196.
    1. NAV. Sickness Absence Statistics, First Quarter 2005–2014. Oslo: Norwegian Labour and Welfare Administration (NAV); 2014.
    1. Brox JI, Storheim K, Grotle M, et al. Evidence-informed management of chronic low back pain with back schools, brief education, and fear-avoidance training. Spine J 2008; 8:28–39.

Publication types