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Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain

Primary Purpose

Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Interdisciplinary intervention
Control Group, Brief Intervention
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring Sick leave, musculoskeletal pain, return to work, multidisciplinary intervention, randomised controlled trial

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Controll group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2011
Last Updated
August 2, 2016
Sponsor
Sykehuset Innlandet HF
Collaborators
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT01346423
Brief Title
Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain
Official Title
Is Interdisciplinary Intervention for Patients Sicklisted With Musculoskeletal Pain More Effective in Helping Patients Back to Work Than Than The Less Resource Demanding Brief Intervention Method?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sykehuset Innlandet HF
Collaborators
University of Bergen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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?
Detailed Description
In 2007 The Government in Norway raised a fund to support efforts to reduce sickness absence, called "Raskere tilbake prosjekt". Helse Sør-Øst was invited to establish projects within their health care system, and the department of physical medicine and rehabilitation at Sykehuset Innlandet HF was assigned the task to constitute an outpatient-clinic for musculoskeletal diseases. This initiative opened possibilities to explore new strategies based on science and own clinical experience to help these patients back to work without being confined to the traditional diagnose related examination and treatment offered in most clinics. In this project the main focus is directed towards work and barriers for working life. Because sickness absence often is multicausal and needs a bio-psycho-social approach, this should be reflected in the composition of the treatment team. There is a great demand to make out how complex bio-psycho-social problems can be solved, organized, implemented, and have economic gains for the society. To answer these questions we need randomized controlled clinical studies, and we need documentation when new treatment models are offered to this group of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases
Keywords
Sick leave, musculoskeletal pain, return to work, multidisciplinary intervention, randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Controll group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary intervention
Other Intervention Name(s)
ISIVET, visual educational tool, interdisciplinary structured interview, multidisciplinary intervention, multidisciplinary treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group, Brief Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Sickness leave 1 year after inclusion
Description
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.
Time Frame
At 12 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Musculoskeletal diagnosis Minimum 50% sick leave from work for not more than one year Minimum 50 % employed Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli M. Hagen, MD, PhD
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Study Chair
Facility Information:
Facility Name
Dep. of Physica. Medicin and Rehabilitation, Innlandet Hospital Trust
City
Ottestad
ZIP/Postal Code
2312
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26910406
Citation
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.
Results Reference
derived
Links:
URL
http://sykehuset-innlandet.no
Description
Info about the project: Raskere tilbake

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Interdisciplinary Intervention Versus Brief Intervention for Patients With Musculoskeletal Pain

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