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OpenTrials
Completed

NCT Number: NCT02836730

Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis

The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar disc herniation and 60-70% in patients with spinal stenosis.

At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc herniation and spinal stenosis are treated by a multidisciplinary team comprising rheumatologists, physiotherapists, chiropractors, and social workers according to current guidelines. Therefore we have a unique opportunity to report the long term outcome in candidates for surgery, regardless of whether they have surgery or not, after having received optimal but unsuccessful nonsurgical treatment.

The purpose of this study is to answer the following questions: 1) What is the proportion of patients operated upon after referral to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment? 2) What was the outcome in these patients 2 years following referral? 3) Where any baseline variables predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in patients with or without surgery?

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Spinal Stenosis Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Back and Rehabilitation Center Copenhagen

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Duration of symptoms more than 3 months
  • Positive imaging findings
  • Non-surgical treatment unsuccessful

Exclusion criteria

  • Age below 18 or above 65 years
  • Lumbar fusion
  • Psychiatric disorders
  • Other serious diseases
  • Unable to understand the Danish language

Treatment and study plan

Low back pain surgery

Procedure

Primary outcomes

  1. Disability

    Time frame: 2 years follow-up

    Roland Morris Disability Questionnaire. lack of success is defined as less than 30% improvement

Secondary outcomes

  1. Back og leg pain

    Time frame: 2 years follow-up

    10 point Numeric Rating Scales for current pain, worst pain and average pain. Lack of success defined as less than 30% improvement.

  2. Global outcome

    Time frame: 2 years follow-up

    5 point Likert Scale. Lack of success is defined as a score of No change, Worse, or Much worse

  3. Reoperation during follow-up

    Time frame: 2 years follow-up

    Self reporting by questionnare

  4. Sick leave because of back pain

    Time frame: 2 years follow-up

    Self reporting by questionnare

  5. Contacts to the health care system because of back pain

    Time frame: 2 years follow-up

    Self reporting by questionnare

Sponsors and collaborators

Lead sponsor

Back and Rehabilitation Center, Copenhagen

Other Gov

Collaborators

  • University Hospital Bispebjerg and Frederiksberg
  • University of Southern Denmark

Registry information

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
Jul 19, 2016
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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