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Return to Work After Early Intervention for Lumbar Disc Herniation Versus Usual Care

NCT04657354 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-11-27

No results posted yet for this study

Summary

The most common cause of low back pain with radiculopathy among the working population is a Lumbar Disc Herniation (LDH). In general, the natural history of sciatica is favourable with spontaneous remission. For the subgroup with more severe symptoms that do not resolve the vocational prognosis is unfavourable in more than 1/3 of the patients. Factors negatively affecting return to work were unskilled labour and less than 40 weeks of employment.

Other than poorer prognosis for patients undergoing discectomy six months or later after the onset of symptoms, there is no consensus on the timing of discectomy. National guidelines in Denmark recommend referral to a spine surgeon if the patient's symptoms have not resolved within 8-12 weeks. However, recent studies have shown that duration of sick leave is associated with poorer clinical outcomes and lower return to work rates.

The purpose of this study is to establish if early surgical evaluation of patients with symptomatic LDH can improve return to work rates. A secondary purpose is to analyse the socioeconomic benefits or costs of an earlier surgical evaluation.

This is a randomized controlled study of two parallel groups of patients who contact their general practitioner for pain relief due to LDH and have been on a minimum of 2 weeks of paid leave. The patients will be randomised to either fast track surgical evaluation or usual care. After informed consent, the subjects will be followed for a period of 12 months.

There are ethical considerations to address including the potential risk of performing surgery if the patient's symptoms could have resolved spontaneously. On the other hand, delayed discectomy could increase the risks of developing chronic pain and loss of work. Thus, the intervention being studied is early referral to a spine surgeon and not discectomy per se. This allows the subject to make a preference-based decision with the surgeon to have a discectomy or not.

Conditions

  • Herniated Disk Lumbar

Interventions

PROCEDURE

Assessment

Early surgical assessment

Sponsors & Collaborators

  • Spine Centre of Southern Denmark

    lead OTHER

Principal Investigators

  • Thomas Ankjaer, MD · Spine centre Middelfart University of Southerne Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2024-12-31
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657354 on ClinicalTrials.gov