Early Mobilisation Following Discectomy

May 27, 2015 updated by: Northern Orthopaedic Division, Denmark
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is a major cause of delayed convalescence after discectomy. Different analgesic treatments with the use of local analgesics and steroid can reduce the immediate postoperative pain and convalescence after surgery. In orthopaedic and abdominal surgery accelerated stay programs with early mobilisation have reduced pain in the early postoperative periode. The late convalescence after discectomy for herniated disc disease can be reduced with the use of epidural steroids.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Northern Orthopaedic Division, Aalborg Hospital, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Median age 45 years, 18-63.
Behavioral: Care program
Care program with multimodal pain treatment including epidural steroid
Other Names:
  • No other names.
Behavioral: Care program
Care program with multimodal pain treatment including epidural steroid.
Other Names:
  • No other names.
Intervention group
Median age 46 years, 18-62.
Behavioral: Care program
Care program with multimodal pain treatment including epidural steroid
Other Names:
  • No other names.
Behavioral: Care program
Care program with multimodal pain treatment including epidural steroid.
Other Names:
  • No other names.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Vejle Hospital
Copenhagen University Hospital, Denmark

Investigators

  • Study Chair: David S. Krum-Moeller, 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
  • Principal Investigator: Sten Rasmussen, M.D., Northern Orthopaedic Department, Aalborg University Hospital, Denmark
  • Study Chair: Lene R. Lauridsen, M.D., Department of Orthopaedic Surgery, Vejle and Give Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ON-07-006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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