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The PLUS Study: Preventing Lumbar disc surgery

The PLUS Study: Preventing Lumbar disc surgery - PLUS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50214
Enrollment
146
Registered
2020-07-28
Start date
2017-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sciatica and herniated nucleus pulposus

Interventions

The combination intervention (MDT and TESIs) will be administered as follows
Using MDT principles and based on pain responses, participants are classified as centralizers or non-centralizers. Centralizers get specific MDT exercises and advice. Non-centralizers will be inject
1) resolved symptoms
2) centralizing and significantly less pain, 3) non centralizing and significantly less pain and 4) non-centralizing with high levels of pain. In the first three groups mentioned here, patients will
non-centralising with high levels of pain will be referred back for surgery. Patients randomized to the control intervention group will placed on a waiting list and scheduled to receive lumbar disc
Injection
Sciatica
Surgery

Sponsors

ZonMw
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Incapacitating lumbosacral radicular syndrome with leg pain, NRS>6, (with or without back pain) that had lasted for a minimum of 6 weeks with or without mild neurological deficit, medical research council (MRC) muscle scale higher than 3 • Magnetic resonance imaging (MRI) which confirms a lumbar HNP that compromises the spinal nerve and can explain the clinical symptoms of the patient • The patients should according to usual care have an indication for lumbar HNP operation by a neurosurgeon. • Signed informed consent for participation in the study • 18 years and above

Exclusion criteria

Exclusion criteria: • Patients suffering from cauda equina syndrome • Previous spine surgery at the same level during the previous 6 months • Previous transforminal injections at the same level during the previous 6 months • Bony stenosis • Spondylolisthesis • Pregnancy • Complicated disc herniation requiring more operations • Severe coexisting disease e.g. osteoporosis, dementia • Patient with contra-indications for steroids injections • Insufficient knowledge of the Dutch language • Emergency surgery as determined by the neurosurgeon • Being allergic for OMNIPAQUE 240

Design outcomes

Primary

MeasureTime frame
Surgery rate (number of patients undergoing surgery during a 12-month follow-up)

Secondary

MeasureTime frame
Back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), health-related quality of life (EQ-5D-5L) en societal costs.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)