Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04657354 |
| Other study ID # |
20/34764 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2021 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Spine Centre of Southern Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Design The study design will be a randomized parallel group prospective study of patients
from the region of Southern Denmark and the region Zealand with sciatica due to LDH
randomized to either early surgical evaluation or usual care as per recommendations from the
Danish National Health Board
Study population Study subjects are identified from the patient population in the region of
Southern Denmark and the Region of Zealand clinically diagnosed with LDH by their general
practitioner.
Randomisation procedure Eligible patients are randomised into one of two arms, usual care or
fast track surgical evaluation with a 1:1 Block sealed envelope randomisation used. A
randomized block design, stratified by the two surgical sites, is used to ensure equal
distribution of the two treatment arms in regions. The randomisation procedure is concealed
and administered by the primary investigator. Randomisation is performed after the patient
has signed the informed consent form. The result of the randomisation is documented in the
subjects' trial record.
Study Arms:
Subject withdrawal If a subject develops a clinically significant medical or surgical
condition that in the opinion of the investigator could impact the patient's ability to
successfully complete the trial or otherwise interfere with outcomes, the subject will be
withdrawn.
If the patient during the trial or follow-up period receives other medical or invasive
intervention that in the opinion of the investigator could impact on the patient's ability to
successfully complete the trial or otherwise interfere with outcomes, the subject will be
withdrawn,
These subjects will not be included in the final analysis
Patient course In Denmark the General Practioners' (GP's) are organised in clusters to ensure
a uniform quality of treatment. The study will be presented to all pre-existing GP-clusters
in the two participating regions at a GP-cluster meeting prior to the study by investigator.
Individual written consent from the GP to participate is obtained at the meeting. All GP's
not present will be identified and contacted individually to obtain written consent. All
participating GP's are informed and consent that all study subjects will, for the duration of
the study, be seen and treated by the investigator GP regarding their LDH, to include all
consultations, scripts, off work certificates, referrals etc. for as long as the patient is
part of the study. All patient encounters will be documented, and relevant information given
to respective GP's ongoing. Two laminated coloured A4 posters are distributed to each GP, one
for the GP and one for reception with trial name, screening criteria and investigators phone
number and e-mail.
Both the GP's who participate and don't participate in the study are recorded. All patients
that meet screening criteria are asked if investigator can contact them by phone.
Investigator then calls the patient to assess inclusion and exclusion criteria. If study
subject is found eligible then they will be thoroughly informed of the study and informed
consent is obtained per mail and an appointment for clinic visit with the Principal
Investigator is scheduled within one week is given. Information and inclusion of participants
will be conducted in accordance with the guidelines of the Health Research Ethics Committee
System in Denmark, from which approval will be sought.
During the first interview and examination, all study subjects' complete questionnaires as
per Table 1.
Study subjects in Usual Care will be treated following the Danish National Guidelines; get
relevant prescriptions, certificates, x-ray and physio/chiropractor referral as per standard
recommendations Study subjects in Fast Track arm will get an MRI done on the same day. All
MRIS will be performed and read at Middelfart Sygehus or Zealand University Hospital. If the
MRI shows concordant findings of herniated disc, the subject will be referred to a spine
surgeon to be seen within one week.
The surgeon will assess the patient and ensure the magnetic resonance image (MRI)
demonstrates a lumbar disc herniation, with the level and side corresponding with clinical
symptoms such as lower extremity radicular pain and/or affection of neurological function.
The subject and the surgeon will discuss the benefits and risks of a discectomy with the
subject. A decision regarding discectomy will be made taking into consideration the subject's
preference. 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.
All discectomies for subjects in Fast Track arm will be performed at one of three Spine
Surgery Centres, Middelfart Sygehus, Odense Universitets Hospital (OUH) or Department of
Orthopaedic Surgery, Zealand University Hospital, Køge. Depending on the surgeon's
preference, the surgical techniques will vary between open discectomy with or without the use
of microscope and tubular-discectomy.
Discectomies for subjects in Usual Care will be performed by a qualified spine surgeon but
not necessary at one of the three centres.
All patients irrespectively to study arm and treatment site are scheduled to standard
post-operative out-patient program with clinic visits as all Danish patients are legally
entitled to a free course of rehabilitation in the municipal centers. Rehabilitation programs
typically last 8-10 weeks and consist of either team or individual training 1-2 times weekly
combined with home exercises (13) Study subjects in both arms will be mailed questionnaires
as per table 1 and a SMS text reminder 3 days later if reply haven been recorded. This will
be handled automatically by RedCap. If still no reply is recorded, then investigator will
phone the study subject 7 days post mail.
