NCT01710683

Brief Summary

After lumbar discectomy 1st postoperative day high intensity exercise training reduced hospital stay, pain and sick leave without side effects in the two year follow-up period.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

First QC Date

October 17, 2012

Last Update Submit

May 27, 2015

Conditions

Reduced Hospital Stay Without Complication

Keywords

Discectomy1st postoperative dayIntensive exercise trainingRandomized controlled trial

Study Arms (2)

Control group

Median age 45 years, 18-63.

Behavioral: Care program

Intervention group

Median age 46 years, 18-62.

Behavioral: Care program

Interventions

Care programBEHAVIORAL

Care program with multimodal pain treatment including epidural steroid

Also known as: No other names.
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic.

You may qualify if:

  • Patients with primary lumbar herniated disc disease who have received and performed a standardized conservative treatment program with intensive exercises.
  • Oral and written acceptance.
  • Age 18 and above.

You may not qualify if:

  • Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion.
  • Patients with cauda equina syndrome who needed acute operative treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Orthopaedic Division, Aalborg Hospital, Aarhus University

Aalborg, Denmark

Location

Study Officials

  • Sten Rasmussen, M.D.

    Northern Orthopaedic Department, Aalborg University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • David S. Krum-Moeller, M.D.

    Department of Orthopaedic Surgery, Vejle and Give Hospital

    STUDY CHAIR

  • Lene R. Lauridsen, M.D.

    Department of Orthopaedic Surgery, Vejle and Give Hospital

    STUDY CHAIR

  • Henrik Kehlet, M.D.

    Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen

    STUDY CHAIR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2012

First Posted

October 19, 2012

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DK(1)