ISRCTN ISRCTN14206374
DOI https://doi.org/10.1186/ISRCTN14206374
Secondary identifying numbers S50782
Submission date
17/02/2008
Registration date
10/03/2008
Last edited
10/03/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Bart Depreitere
Scientific

Department of Neurosurgery
University Hospitals Leuven
Herestraat 49
Leuven
3000
Belgium

Study information

Study designInterventional, randomised, single centre trial with four arms (two variables: early specific physio versus later non-specific physio; transmuscular versus paramedian surgical approach).
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet (in Dutch).
Scientific titlePosture control after lumbar microdiscectomy: effect of transmuscular surgical approach and of early postoperative physiotherapy - a randomised clinical trial
Study objectives1. 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(s)Ethics approval received from the Commissie Medische Ethiek of Leuven University Hospitals in November 2007.
Health condition(s) or problem(s) studiedSciatica caused by a lumbar disc herniation
Intervention1. 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 typeOther
Primary outcome measureMuscle 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 measuresComfort:
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 study start date18/02/2008
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants100
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment18/02/2008
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Belgium

Study participating centre

Department of Neurosurgery
Leuven
3000
Belgium

Sponsor information

University Hospitals Leuven (The Netherlands)
Hospital/treatment centre

Herestraat 49
Leuven
3000
Belgium

Website http://www.uzleuven.be/
ROR logo "ROR" https://ror.org/0424bsv16

Funders

Funder type

Industry

Contribution for logistic expenses:

No information available

Medtronic B.V. (The Netherlands)

No information available

Stryker Nederland (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan