Effect of spinal orthosis on activity and quality of life in patients after nucleotomy or diskektomy

Phase 4

Conditions: M50
M51
Cervical disc disorders
Other intervertebral disc disorders

Registration Number: DRKS00022131

Lead Sponsor: niversitätsklinikum Bonn Klinik und Poliklinik für Orthopädie und Unfallchirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 48

Inclusion Criteria

Patients with the indication for nucleotomy or diskektomy
- Age: 30-70 years

Exclusion Criteria

- non-operational limitations in mobility
- postoperative complications and forther surgical interventions
- age: younger than 30 or older than 70 years
- systematic neurological diseases with limitation in mobility e.g. advanced Parkinson's disease or multiple sclerosis
- mental illnesses and those associated with chronic pain
- patients with intolerances or known limitations making participation in the study impossible
- higher grade spinal canal stenosis
- instability of the spine (Spondylolisthesis: Meyerding > grade 2)
- severe scolliosis (degenerative/idiopathic)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of steps within the first six weeks after surgery. An activity tracker is used to record the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
The following parameters are measured before surgery, after surgery, 2 weeks, 6 weeks, 3 months and 6 months after surgery: subjective pain condition and pain-related disorders (German Pain Questionnaire, Core Outcome Measures Index); subjective physical activity (Freiburger Activity Questionnaire); subjective quality of life (SF-36 and EQ-5D questionnaire); subjective fear of falling (Falls Efficacy Scale); orthosis specific questions.<br><br>The following parameters are measured before surgery, after surgery, 2 weeks and 6 weeks after surgery:<br>sagital spine profile (Spinalmouse); subjective uncertain gait; objective safey of movement (Timed up and Go Test, Modified daily life test); pressure pain threshold (pressure algometry).<br><br>The following parameters are measured within 6 weeks after surgery: activity diary (state of health, steps per day - weekly summaries); wearing time of the orthosis - intervention group only.