Condition category
Digestive System
Date applied
26/03/2009
Date assigned
10/08/2009
Last edited
10/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heikki Österman

ORCID ID

Contact details

Tenholantie 10
Helsinki
00280
Finland
heikki.osterman@orton.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Iskari

Study hypothesis

Evidence on the best management of sciatica of 6 to 12 weeks' duration is limited. Surgical patients seem to have a more rapid recovery in the very short term, but the effectiveness of surgical management in mid- and long-term is unclear.

Ethics approval

Ethical Boards of Jorvi Hospital and University Hospitals of Tampere, Kupio and Oulu approved in Autumn 1996

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lumbar disc herniation

Intervention

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 patients were encouraged to do isometric muscle exercises and walk right from the start; 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 weeks.

Duration of treatment can be estimated at six weeks, after that the study involved observation only. Follow-up of both arms is planned to last ten years, 2- and 6-year results have been assessed (2-year results published).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/01/1997

Overall trial end date

31/12/1999

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

56

Participant 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

Recruitment start date

01/01/1997

Recruitment end date

31/12/1999

Locations

Countries of recruitment

Finland

Trial participating centre

Tenholantie 10
Helsinki
00280
Finland

Sponsor information

Organisation

Finnish Centre for Welfare and Health (Finland)

Sponsor details

P.O. Box 30
Helsinki
00271
Finland
info@thl.fi

Sponsor type

Government

Website

http://www.thl.fi

Funders

Funder type

Government

Funder name

Finnish Centre for Welfare and Health (Finland) - funding in the planning phase of the study

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes