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
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