Condition category
Musculoskeletal Diseases
Date applied
17/02/2008
Date assigned
10/03/2008
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Bart Depreitere

ORCID ID

Contact details

Department of Neurosurgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S50782

Study information

Scientific title

Posture control after lumbar microdiscectomy: effect of transmuscular surgical approach and of early postoperative physiotherapy - a randomised clinical trial

Acronym

Study hypothesis

1. Transmuscular surgical approach causes less damage to postoperative posture control because it does not damage the back muscle insertions
2. Early postoperative physiotherapy improves short and long term posture control

Ethics approval

Ethics approval received from the Commissie Medische Ethiek of Leuven University Hospitals in November 2007.

Study design

Interventional, randomised, single centre trial with four arms (two variables: early specific physio versus later non-specific physio; transmuscular versus paramedian surgical approach).

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in Dutch).

Condition

Sciatica caused by a lumbar disc herniation

Intervention

1. Transmuscular surgical approach versus classic paramedian approach to the disc herniation at surgery
2. Early postoperative physiotherapy, starting two weeks postoperatively, and consisting of an individualised program with standardised goals versus 'conservative' treatment: no physiotherapy in the first six weeks post-operation and after six weeks only when indicated

Follow up is one year for all four arms.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Muscle control (assessed by postural balance test and sit-to-stand test), assessed in the lab at two weeks, eight weeks and six months post-operatively.

Secondary outcome measures

Comfort:
1. Back pain
2. Sciatica
3. Functional status
4. Return to work

Secondary outcome measures are assessed by standardised patient questionnaires preoperatively and at two weeks, eight weeks, six months and one year postoperatively.

Overall trial start date

18/02/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. One level disc herniation, either L4-L5 or L5-S1, explaining symptoms and representing operative indication. Purely median disc herniations are excluded.
2. Age: 18 - 60 years, either sex
3. Living within 30 km perimeter of the hospital
4. Informed consent signed

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Emergency operation required
2. Litigation, worker's compensation
3. Clinical suspicion of depression or fibromyalgia (the suffering is not exlusively explained by the disc herniation)
4. Previous lumbar surgery, irrespective of the level
5. Significant neurological deficit (weakness worse than 4/5)
6. Systemic disease significantly affecting patient's functioning (American Society of Anaesthesiologists [ASA] grade greater than 3)
7. Median disc herniation
8. Patient unable to communicate in the Dutch language

Recruitment start date

18/02/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Belgium

Trial participating centre

Department of Neurosurgery
Leuven
3000
Belgium

Sponsor information

Organisation

University Hospitals Leuven (The Netherlands)

Sponsor details

Herestraat 49
Leuven
3000
Belgium

Sponsor type

Hospital/treatment centre

Website

http://www.uzleuven.be/

Funders

Funder type

Industry

Funder name

Contribution for logistic expenses:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medtronic B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Stryker Nederland (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes