Posture control after lumbar microdiscectomy

ISRCTN	ISRCTN14206374
DOI	https://doi.org/10.1186/ISRCTN14206374
Protocol serial number	S50782
Sponsor	University Hospitals Leuven (The Netherlands)
Funders	Contribution for logistic expenses:, Medtronic B.V. (The Netherlands), Stryker Nederland (The Netherlands)

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

Primary study design	Interventional
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).
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Posture control after lumbar microdiscectomy: effect of transmuscular surgical approach and of early postoperative physiotherapy - a randomised clinical trial
Study objectives	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(s)	Ethics approval received from the Commissie Medische Ethiek of Leuven University Hospitals in November 2007.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	18/02/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Belgium

Study participating centre

Department of Neurosurgery

Leuven
3000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes