- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01710683
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Withdrawn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
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Aalborg, Denmark
- Northern Orthopaedic Division, Aalborg Hospital, Aarhus University
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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 |
|---|---|
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Control group
Median age 45 years, 18-63.
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Care program with multimodal pain treatment including epidural steroid
Other Names:
Care program with multimodal pain treatment including epidural steroid.
Other Names:
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Intervention group
Median age 46 years, 18-62.
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Care program with multimodal pain treatment including epidural steroid
Other Names:
Care program with multimodal pain treatment including epidural steroid.
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
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.