NCT00840697

Brief Summary

Low back pain is a usual condition in the western countries and several treatments available for patients with "non-specific low back pain". According to the European guidelines both Brief intervention and exercise/cognitive intervention are effective treatments with regard to pain and function (www.backpaineurope.org), but none have documented effect on return to work. The challenges for health personnel is not cure of the patients back pain, but to build up rehabilitation programs which focus on disability and work incapacity, in patients which are at risk of loosing their work. Dr. P. Loisel, Montreal, Canada", has since 1995 treated patients with back pain according to the "The PREVICAP model - (PREVention of work handICAP)", where the main purpose with work-related program is to prevent prolonged disability and to help patients back to work. Loisel demonstrated that the PREVICAP models accelerated the "return to work" factor by a factor 2.4 (p=0.01). The PREVICAP model had also been evaluated in Amsterdam, by Dr. Anema with the same results. At the Back Clinic, UllevÄl University Hospital we are presently involved in a randomized controlled trial after the PREVICAP model, where patients are randomized to Brief intervention including a work-related intervention or usual care. All included patients in both groups, will have a clinical examination by specialist in Physical Medicine and Rehabilitation and advice from a physiotherapist. The current study replaces Brief intervention with an exercise - and a work-related program, so patients with non-specific LBP will be randomized to an exercise and work-related program or usual care. The main purpose of this study

  • to investigate if rehabilitation programs specifically focusing on the return to work process will reduce sickness absence and disability pension in patients with neck and low back pain.
  • to assess the work-, individual- and health factors and their interrelationship predicting sickness absence and work disability.
  • to compare results from the rehabilitation program with results from rehabilitation program in Toronto
  • to which extent are the patients met by actions from employers and employment services, and does is influence sickness absence and disability.
  • do these actions represent favourable cost benefit for the work places and the society

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 27, 2011

Status Verified

May 1, 2011

Enrollment Period

2 years

First QC Date

February 9, 2009

Last Update Submit

June 24, 2011

Conditions

Keywords

low back painneck painreturn to workexercisescognitive intervention

Outcome Measures

Primary Outcomes (1)

  • return to work rate

    week

Secondary Outcomes (1)

  • Cost benefit, predictors (work, individual and health factors) of poor return to work rate,

    year

Study Arms (3)

Work related rehabilitation

ACTIVE COMPARATOR

work related rehabilitation and exercises The workplace intervention includes two steps: Evaluations of the work site: The occupational ergonomists task is to identify conditions at the work site, as for instance ergonomic, work demand and relations to the employer and colleagues. Therapeutic Return to work: The occupational ergonomists will organize contacts and meetings between the employer and the patients and make a schedule for return to work. The therapeutic return-to-work-process will take place at the work place, with progressively more days at work and progressively increasing tasks. Exercises comprises of treatment in groups. The treatment includes exercises, both strength and fitness, in addition to cognitive intervention of how to manage pain and work.

Behavioral: Exercises and work related rehabilitation

Brief intervention

ACTIVE COMPARATOR

1 consultation at the physiotherapist, which give advise and a summary talk with the physician

Behavioral: Brief intervention

Multidisciplinary exercise group

ACTIVE COMPARATOR

10 days of exercise and cognitive treatment group

Behavioral: multidisciplinary exercise group

Interventions

Treatment in groups, twice a week for 3 weeks. The treatment includes exercises, cognitive intervention and work related rehabilitation. The exercises include fitness, strength and stretching

Also known as: return to work, Low back pain, Behavioral
Work related rehabilitation

1 consultation at the physiotherapist, which give advice Summary talk with the physician about activity and work when having neck- and low back pain

Brief intervention

10 days during 3 weeks. Treatment in groups, exercise and cognitive treatment

Multidisciplinary exercise group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with low back pain, sick listed for less than 1 year and who are permanently employed

You may not qualify if:

  • Patients with infection, tumors, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or cauda equina syndrome, spinal stenosis or spondylolysis/listesis, serious somatic disease and/or psychic disease and patients with with poor proficiency in Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ullevaal University Hospital

Oslo, 0407, Norway

RECRUITING

Related Publications (1)

  • Marchand GH, Myhre K, Leivseth G, Sandvik L, Lau B, Bautz-Holter E, Roe C. Change in pain, disability and influence of fear-avoidance in a work-focused intervention on neck and back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 21;16:94. doi: 10.1186/s12891-015-0553-y.

MeSH Terms

Conditions

Low Back PainNeck PainMotor Activity

Interventions

ExerciseReturn to WorkCrisis Intervention

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEmploymentSocioeconomic FactorsPopulation CharacteristicsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Erik Bautz-Holter, Professor

    Ullevaal University Hospital

    STUDY DIRECTOR

Central Study Contacts

Anne Keller, Dr.med.Sc

CONTACT

Erik Bautz-Holter, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 10, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2013

Last Updated

June 27, 2011

Record last verified: 2011-05

Locations