Early Mobilisation Following Discectomy | NCT01710683

Studies
Early Mobilisation Following Discectomy

NCT01710683

Sponsor

Northern Orthopaedic Division, Denmark

Status

Withdrawn

Last Update Posted

May 28, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Reduced Hospital Stay Without Complication

Interventions

Care program
Care program

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants were enrolled.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 17, 2012

First Submission Date that Met QC Criteria

Oct 17, 2012

First Posted Date

Oct 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Name	Class
Vejle Hospital	OTHER
Copenhagen University Hospital, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group		Median age 45 years, 18-63.	Behavioral: Care program
Intervention group		Median age 46 years, 18-62.	Behavioral: Care program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Care program	Behavioral	Care program with multimodal pain treatment including epidural steroid	Control group

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Aalborg Hospital, Aarhus University		Aalborg			Denmark