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Preventing lumbar disc surgery

Conditions
herniated nucleus pulpos patients
Registration Number
NL-OMON22180
Lead Sponsor
VU Amsterdam, Faculty FALW, Dept. of Health Sciences, room T557, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
146
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

Exclusion Criteria

A potentially eligible subject who meets any of the following criteria will be excluded from participation in this study:

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Surgery rate, number of patients undergoing surgery during a 12-month follow-up.
Secondary Outcome Measures
NameTimeMethod
- Self-reported leg pain (0-100 numeric pain rating scale (NPRS)), Timepoint: baseline, 4 weeks, 2 months, 4 months, 6 months, 9 months, 12 months.<br /><br>- Self-reported back pain (0-100 NPRS), Timepoint: baseline, 4 weeks, 2 months, 4 months, 6 months, 9 months, 12 months.<br /><br>- Functional status (Roland Morris Disability Questionnaires (RMDQ-23)), Timepoint: baseline, 2 months, 4 months, 6 months, 9 months, 12 months.<br /><br>- Self-perceived recovery (Global Perceived Effect scale), Timepoint: 2 months, 4 months, 6 months, 9 months, 12 months.<br /><br>- Health-related quality of life (SF-12; EQ-5D-5L), Timepoint: baseline, 2 months, 4 months, 6 months, 9 months, 12 months.<br /><br>- Societal and healthcare costs, Timepoint: baseline, 2 months, 4 months, 6 months, 9 months, 12 months.<br>
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