NCT03010384

Brief Summary

The aim of this study was to investigate the impact of a rehabilitation program including a physician specialized in social medicine parallel to treatment for suspected spinal disc herniation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

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

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
Last Updated

January 5, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

December 6, 2016

Last Update Submit

January 3, 2017

Conditions

Return to WorkMusculoskeletal Disease

Outcome Measures

Primary Outcomes (1)

  • Return to Work (register based information)

    one year

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Consultation with a physician specialized in social medicine. The consultation lasted about one hour. Together with the patient a return-to-work (RTW) schedule was made to ascertain the need for contact to the workplace (to adjust work functions), municipality, general practitioner or short-term supportive consultations with a psychologist. If relevant, patients were offered up till 5 sessions with a psychologist.

Other: Rehabilitation program

Control

NO INTERVENTION

Standard treatment from the Department of Rheumatology

Interventions

Rehabilitation programOTHER
Intervention

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥ 18 and \< 60 years old,
  • not receiving disability pension and not on maternity leave.
  • sick leave over the past year for more than ten days
  • low self-rated work ability for the next two years
  • health anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

December 6, 2016

First Posted

January 5, 2017

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

July 1, 2014

Last Updated

January 5, 2017

Record last verified: 2017-01