NCT01346423

Brief Summary

Musculoskeletal pain is very common in the normal population, and the reason for about 50 % of the long term sickness absence in Norway. Most of these patients have common, but troublesome subjective health complaints where pathological findings are absent or substantially less than expected compared to the reported intensity of the complaints. Psychosocial factors are important in the development of chronic complaints. In a large meta-analysis job satisfaction was found to be associated with mental health and subjective physical health. Individual factors are also important. Uncertainty related to the understanding of pain mechanisms, treatment strategies and management contribute to the problem. Among patients sicklisted for musculoskeletal complaints, low back pain is the largest diagnose group. Most of these patients also have many other complaints. Previous studies have shown that for low back pain patients a brief intervention at a spine clinic with examination, information, reassurance, and encouragement to engage in physical activity as normal as possible, had significant effect in reducing sick leave. Other studies have shown that multidisciplinary rehabilitation for chronic low back pain has effect on sick leave. A Danish study from Arbeidsmiljøinstituttet report that interdisciplinary treatment for patients sicklisted for musculoskeletal complaints, had effect on socio-economic costs, pain, and function. A treatment team consisting of various professionals is expensive, and in this study we will compare the simple, standardized brief intervention model with the more resource demanding interdisciplinary treatment for patients sicklisted for musculoskeletal complaints. Research question / hypothesis: An interdisciplinary treatment model for musculoskeletal complaints - is it beneficial for reducing sickness absence?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 3, 2016

Status Verified

March 1, 2011

Enrollment Period

1.8 years

First QC Date

April 14, 2011

Last Update Submit

August 2, 2016

Conditions

Keywords

Sick leavemusculoskeletal painreturn to workmultidisciplinary interventionrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in Sickness leave 1 year after inclusion

    In addition to the main outcome we will also evaluate job satisfaction, social support, coping, defense mechanisms, illness perception, function level, activity of daily living, psychological distress, and health complaints/pain as recorded by the questionnaires at baseline.

    At 12 months after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Treatment team with a physician, a physiotherapist, a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The patient meets at the outpatient clinic three times; at baseline, after 2 weeks and after 3 months. One year after baseline the patient has a telephone-follow-up. At baseline, the patient and the team works out a rehabilitation plan and in this process a new visual, educational tool is central.

Behavioral: Interdisciplinary intervention

Controll group

ACTIVE COMPARATOR

The brief intervention is a standardized intervention based on the studies by Indahl and Hagen. Therapist treatment manuals will be written for the intervention. The essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. Unless symptoms and clinical findings indicate some serious disease, the patients will be informed about the good prognosis, and the importance of staying active to avoid development of muscle dysfunction.

Behavioral: Control Group, Brief Intervention

Interventions

Interdisciplinary collaboration deals with tasks often complex which require different skills to make a wide assessment.In this study the treatment team consists of a physician, a physiotherapist and a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The conclusion of the team will be followed by a targeted rehabilitation plan. Factors assessed to be the major cause of the reduced function at work will have priority in the following rehabilitation process. One of the team members will be responsible for the further process to follow the plan to help the patient back to work, in cooperation with the patient, the workplace, the general practitioner, and NAV.

Also known as: ISIVET, visual educational tool, interdisciplinary structured interview, multidisciplinary intervention, multidisciplinary treatment
Intervention group

The brief intervention is a standardized intervention and the essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. The examination is thorough with detailed feedback on findings and normal functions, and clear and consistent explanations on pain and defense mechanisms. Somatic findings will be explained.Unless pathological findings, the patient will be encouraged to physical activity.

Controll group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Musculoskeletal diagnosis
  • Minimum 50% sick leave from work for not more than one year
  • Minimum 50 % employed

You may not qualify if:

  • Not sicklisted
  • Sicklisted less than 50%
  • Sicklisted \> 1 year
  • Less than 50% employed
  • Pregnancy
  • Does not speak Norwegian
  • Psychiatric disease
  • Osteoporosis
  • Cancer disease
  • Rheumatic disease
  • Ongoing Insurance Compensation Case

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Physica. Medicin and Rehabilitation, Innlandet Hospital Trust

Ottestad, Ottestad, 2312, Norway

Location

Related Publications (1)

  • Brendbekken R, Eriksen HR, Grasdal A, Harris A, Hagen EM, Tangen T. Return to Work in Patients with Chronic Musculoskeletal Pain: Multidisciplinary Intervention Versus Brief Intervention: A Randomized Clinical Trial. J Occup Rehabil. 2017 Mar;27(1):82-91. doi: 10.1007/s10926-016-9634-5.

Related Links

MeSH Terms

Conditions

Musculoskeletal DiseasesMusculoskeletal Pain

Interventions

Control GroupsCrisis Intervention

Condition Hierarchy (Ancestors)

Muscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eli M. Hagen, MD, PhD

    Sykehuset Innlandet HF

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

May 3, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2014

Last Updated

August 3, 2016

Record last verified: 2011-03

Data Sharing

IPD Sharing
Will not share

Locations