1. 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
- Author
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Torill Helene Tveito, Egil Andreas Fors, Livar Frøyland, Stein Atle Lie, Silje Endresen Reme, Anette Harris, Arit Ødegård, Sigmund Østgård Gismervik, Jens Ivar Brox, Tone Tangen, Astrid Grasdal, Trudie Chalder, Aage Indahl, Hege R. Eriksen, and Eli Molde Hagen
- Subjects
Male ,medicine.medical_treatment ,Psychological intervention ,Evaluation of Treatments and Therapeutic Interventions [Musculoskeletal] ,Sick Leave ,absenteeism ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Low Back Pain / psychology ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Cognitive Intervention ,Low Back Pain / therapy ,Middle Aged ,Combined Modality Therapy ,Low back pain ,Cognitive behavioral therapy ,Treatment Outcome ,VDP::Medisinske Fag: 700::Helsefag: 800 ,Oswestry ,Low Back Pain / drug therapy ,Sick leave ,Female ,medicine.symptom ,Dietary Supplements ,Evaluering av behandlinger og terapeutiske intervensjoner [Muskulatur og skjelett] ,Adult ,medicine.medical_specialty ,cognitive behavior therapy ,sick leave ,seal oil ,Brief Intervention ,Young Adult ,03 medical and health sciences ,Multicenter trial ,medicine ,Humans ,Cognitive Behavioral Therapy ,business.industry ,chronic low back pain ,Physical therapy ,Neurology (clinical) ,Brief intervention ,business ,Low Back Pain ,030217 neurology & neurosurgery - 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. 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 The Research Council of Norway, the GC Rieber Funds and Mills DA funds were received in support of this work.
- Published
- 2016
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