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

NCT04657354 | Withdrawn

• 1 other identifier: 20/34764
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

rct; wild; Return to work; sick leave; sciatica; lumbar pain; Radiculopathy; Spine; Quality of life; Herniated lumbar disc

Outcome Measures

Primary Outcomes (1)

• Return to work

  Self-reported work status. Return to work status one year after entry.

  12 months

Secondary Outcomes (3)

• Socioeconomic costs

  12 months

• Patient reported outcome

  12 months

• Surgical rates

  12 months

Study Arms (2)

Fast track

ACTIVE COMPARATOR

Study subjects in Fast Track arm will get an MRI done on the same day. If the MRI shows concordant findings of herniated disc, the subject will be referred to a spine surgeon to be seen within one week. If the surgeon and subject decide on discectomy, the surgery is scheduled within the same week. Total timespan from first interview to surgery will be no longer than 2 weeks.

Procedure: Assessment

Usual care

NO INTERVENTION

Study subjects in Usual Care will be treated following the Danish National Guidelines in which a conservative approach for the first 4-6 weeks with focus on pain relief by pain-relief medication, exercises and encouragement to resume normal activities as much as possible. Patients in this arm will be scheduled 2 and 4 week follow-up appointments as per national guidelines. If the symptoms have not resolved after this period, then a referral to a multidisciplinary spine care department is made. However, if symptoms are still present at 8-12 weeks first then a referral for a spine surgeon assesment can be done.

Interventions

Assessment PROCEDURE

Early surgical assessment

Fast track

Eligibility Criteria

• Age: 18 Years - 67 Years
• Gender Eligibility Details: Working age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed by their GP with LDH
• Sick leave due to LDH
• Duration of sick leave less 6 weeks.
• Age \>= 18
• Able to understand and read Danish
• Informed consent

You may not qualify if:

• History of previous spine surgery or spinal fracture
• History of lumbar radiation therapy
• Current malignant disease or chemotherapy
• Current pregnancy or breast-feeding
• Diagnosis of significant psychiatric disorder
• Contra-indication for spinal surgery or rehabilitation
• Patients that are not eligible to have an MRI scan
• Presence of neurologic deficit requiring urgent decompressive spinal surgery

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

MeSH Terms

Conditions

Sciatica; Low Back Pain; Radiculopathy

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Thomas Ankjaer, MD

  Spine centre Middelfart University of Southerne Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: December 8, 2020
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share