Trial | NCT00463970  Report issue

Title

Cognitive Interventions and Nutritional Supplementation for Patients With Long-lasting Back Pain
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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    seal oil ...

  • Study Participants

    414
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.
Study Started
Feb 29
2008
Primary Completion
Aug 31
2010
Study Completion
Aug 31
2012
Last Update
Feb 23
2017

Behavioral Brief Intervention

Physical examination, education and follow up by a physiotherapist

  • Other names: Brief Education, Light mobilization treatment

Behavioral Cognitive Behavioural Therapy

7 sessions of CBT over a period of 2 months, included a booster session after 3 months

  • Other names: Cognitive behavioral treatment, Cognitive rehabilitation

Dietary Supplement Seal oil

20 capsules per day for 3 months

  • Other names: Marine oil, Nutritional supplement

Dietary Supplement Soy oil

20 capsules per day for 3 months

  • Other names: Vegetable oil, Nutritional supplement

1 Active Comparator

Brief Intervention

2 Experimental

Cognitive Behavioural Therapy

3 Experimental

Seal oil

4 Placebo Comparator

Soy oil

Criteria 

Inclusion Criteria:

Patients sicklisted 2-10 months for low back pain
The following diagnosis are included: L02, L03, L84 and L86

Exclusion Criteria:

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
No Results Posted