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Surgery versus conservative care for lumbar disc herniation

Effectiveness of microdiscectomy for lumbar disc herniation: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50552565
Enrollment
56
Registered
2009-08-10
Start date
1997-01-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Lumbar disc herniation Digestive System Other abdominal hernia

Interventions

Lumbar microdiscectomy versus continued non-surgical care. The non-surgical group was intended to mimic the natural course of healing of disc herniation, thus there was no specific program. The patien
passive forms of treatment were discouraged. Treatment in the operative arm involved having a disc operation and a period of convalescence after that. Duration of treatment in that sense was about six

Sponsors

Finnish Centre for Welfare and Health (Finland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 20 to 50 years, either sex 2. Sciatic pain of 6 - 12 weeks' duration 3. Sciatica below knee and at least one physical finding suggestive of nerve root involvement 4. Computed tomography (CT) verified disc extrusion or sequester compatible with the clinical symptoms and findings

Exclusion criteria

Exclusion criteria: 1. Spontaneous resolution of sciatic symptoms during a minimum follow-up of two weeks 2. Sick leave of more than three months' duration preceding randomisation 3. Spondylolisthesis 4. Symptomatic spinal stenosis 5. Previous spine surgery 6. Pregnancy 7. Major medical or post-traumatic conditions confounding the assessment of effectiveness of treatment 8. Mental or behavioural disorder jeopardising the attachment to the trial protocol

Design outcomes

Primary

MeasureTime frame
Leg pain (Visual Analogue Scale [VAS]). Assessed 6 weeks, 3 months, 6 months, 1 year, 2 years and 6 years post randomisation. A ten-year follow-up will take place in due course.

Secondary

MeasureTime frame
1. Back pain (VAS) 2. Recovery of working ability (VAS) 3. Satisfaction with treatment (VAS) 4. Disability associated with back pain (Oswestry index) 5. Self-assessed global recovery (Likert scale 0 - 6) 6. Physical findings Assessed 6 weeks, 3 months, 6 months, 1 year, 2 years and 6 years post randomisation. A ten-year follow-up will take place in due course.

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026