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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.

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References

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