Reduced Hospital Stay Without ComplicationNCT01710683
Early Mobilisation Following Discectomy
An observational study of Reduced Hospital Stay Without Complication, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduced Hospital Stay Without Complication
- What is being tested?
- Care program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Aalborg Hospital, Aarhus University
Aalborg
About this study
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.
Read the 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.
- Being tested
- Care program
- Keywords
- Discectomy, 1st postoperative day, Intensive exercise training, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care programBehavioural
Also called No other names.
Care program with multimodal pain treatment including epidural steroid
Care programBehavioural
Also called No other names.
Care program with multimodal pain treatment including epidural steroid.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Median age 45 years, 18-63. Receives: Behavioral: Care program | |
| Intervention group | Median age 46 years, 18-62. Receives: Behavioral: Care program |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
Why it stopped: No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduced Hospital Stay Without ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital, Copenhagen University Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Sten Rasmussen, M.D., Principal investigator, Northern Orthopaedic Department, Aalborg University Hospital, DenmarkDavid S. Krum-Moeller, M.D., Study chair, Department of Orthopaedic Surgery, Vejle and Give HospitalLene R. Lauridsen, M.D., Study chair, Department of Orthopaedic Surgery, Vejle and Give HospitalHenrik Kehlet, M.D., Study chair, Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710683
- Sponsor's protocol ID
- ON-07-006
- Status last verified
- May 2015
- First submitted
- 17 Oct 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Mobilisation Following Discectomy
- ClinicalTrials.gov ID
- NCT01710683
- Acronym / sponsor ID
- ON-07-006
- Keywords
- Discectomy, 1st postoperative day, Intensive exercise training, Randomized controlled trial
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Vejle Hospital, Copenhagen University Hospital, Denmark
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Behavioral: Care programMedian age 45 years, 18-63. |
| Intervention group | – | Behavioral: Care programMedian age 46 years, 18-62. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care programAlso: No other names.Care program with multimodal pain treatment including epidural steroid | Behavioural | Control group |
| Care programAlso: No other names.Care program with multimodal pain treatment including epidural steroid. | Behavioural | Intervention group |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sten Rasmussen, M.D. principal investigator
Northern Orthopaedic Department, Aalborg University Hospital, Denmark
David S. Krum-Moeller, M.D. study chair
Department of Orthopaedic Surgery, Vejle and Give Hospital
Lene R. Lauridsen, M.D. study chair
Department of Orthopaedic Surgery, Vejle and Give Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reduced Hospital Stay Without Complication, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015; AzTrials last refreshed its copy on 3 Nov 2026.