(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Although degenerative lumbar stenosis is frequently diagnosed and various
surgical and nonsurgical interventions are widely accepted in clinical
practice, there is limited evidence to support many of them, especially in
terms of their relative benefit and risk compared with other options. The most
common treatment reported in literature is decompressive surgery. In a
meta-analysis by Turner et al. successful results are reported 26 to 100% of
the subjects with a mean follow-up of nearly 4 years. However various studies
observing the natural course of neurogenic claudication also report improvement
of symptoms and conclude that expectant observation could be an alternative to
surgical treatment. There is no evidence-based data to justify the timing of
surgery, which shows a wide variation. Also unknown is whether surgery for
lumbar stenosis is cost-effective, compared to prolonged conservative care. Due
to a lack of scientific data, confirming a favorable natural course of
intermittent neurogenic claudication most Dutch physicians prefer to refer for
surgical decompression and instead of prescribing non-invasive methods, such as
anti-inflammatory medications and physical therapy. The wide variation in the
timing of referral for stenosis surgery depends on factors such as the severity
of the symptoms, the inability of patients to cope with the pain during their
daily activities or social intercourse and patient and doctor preferences.

Evidence from nonsurgical treatment of neurogenic claudication suggests
efficacy for a variety of interventions. At a minimum, patients should receive
active physical therapy, education/counseling with home exercise instruction,
and a nonsteroidal anti-inflammatory drugs (if tolerated). For patients with
inadequate response to nonsurgical interventions and time, surgery is
appropriate to consider, but not proven effective. Authors of available studies
suggest that surgical treatment provides better short-term outcomes than
nonsurgical treatment. As long-term outcomes of non-surgical therapy might be
similar to surgery, it is worthwhile to know if early decompressive surgery is
really necessary to improve the quality of the aging years. Possibly a 6 months
prolonged conservative treatment approach with a standardized exercise
protocol, education/counseling by the general practitioner, prescription of
analgesics and eventually delayed surgery in a smaller population of patients
with persisting complaints is a more (cost)effective approach.

Intermittent neurogenic claudication due to lumbar stenosis is frequently
diagnosed among older persons. Due to an aging population it is to be expected
the incidence of lumbar stenosis will increase over time. Patients are operated
on because of intolerable pain and/or severe decreased daily activities, with
the aim of pain relief and conservation or restoration of normal day-to-day
activities. The duration of persistent back/leg pain before elective surgery is
offered is not a case of evidence-based medicine but is a reflection of normal
practice. Although there is consensus that surgery is only offered in the case
of persistent pain, the timing of this treatment seems to depend on local
production capacity and patient and doctor preferences rather than
evidence-based practice. The main goal of this comparative study is to
investigate whether a period of at least 3 months of persistent intermittent
neurogenic claudication is justified as a solid indication for surgery and
superior to a prolonged conservative treatment policy for this condition.

The defined research questions of the proposed study are:

1. Is a policy of conventional surgical intervention more (cost) effective than
prolonged conservative care in patients with at least 3 months intermittent
neurogenic claudication due to lumbar spinal stenosis?

2. Is it possible to define subgroups of patients who will benefit
substantially from one of the two proposed treatment strategies?

To answer the main research question a prospective, multi-centre comparative
randomized clinical trial with parallel group design will be conducted. The
follow-up will last 5 years. The multi-centre design is necessary to include
the required amount of patients and obtain generalizable results.

All patients presenting to the neurologist of the participating hospitals with
complaints of intermittent neurogenic claudication for at least 3 months are
eligible for inclusion. The hospitals participating in this study are:

- LUMC Leiden
- MC Haaglanden The Hague and Leidschendam
- Haga Ziekenhuis The Hague
- Bronovo Ziekenhuis The Hague
- Reinier de Graaf Gasthuis Delft
- Vlietland Ziekenhuis Schiedam
- Groene Hart Ziekenhuis Gouda
- Rijnlands Ziekenhuis Leiderdorp
- Diaconessenhuis Leiden
- Lange Land Ziekenhuis Zoetermeer
- Spaarne Ziekenhuis Hoofddorp

The LUMC will function as coordinating hospital for the proposed trial. All
participating hospitals take own responsibility for the treatment of subjects.
The randomization and collection of study data will be carried out by the
research nurse at the outpatient clinics of the participating hospitals.

General practitioners and physical therapists will be informed about the study
and asked for their cooperation. They will be directly involved in the study.
General practitioners and physical therapists will provide primary care for
subjects allocated to prolonged conservative care. Second, general
practitioners will be asked to refer patients within 3 months of onset of
intermittent neurogenic claudication to the outpatient clinics for evaluation
by the neurologist. Patients will be randomized if the diagnosis lumbar
stenosis is confirmed by imaging findings. Participants will be allocated to
either prolonged conservative care or direct surgery. The general practitioner
will provide adequate pain medication and advise the patients to stay active
and if possible return to work and/or their leisure activities. Further,
patients are prescribed physical therapy that consists of active exercises to
guide the patient in upgrading his or her activities according to the agreed
time schedule. Patients allocated to the direct surgery group will be operated
within 4 weeks after randomization. Early surgery will be compared to a policy
of prolonged conservative care.

Demographic and clinical data will be collected at baseline and during
consecutive follow-up visits to the outpatient clinics. Further, patients will
complete questionnaires and a diary during the follow-up period. Information on
pain intensity, physical examination findings, imaging findings, illness
related disability, societal costs and utilities and quality of life will be
collected. For the cost-effectiveness analysis a societal perspective will be
taken, including health care costs and costs due to disability.

A prolonged conservative treatment policy will be conducted by the general
practitioner (GP) and physical therapist. The GP will check the efficacy of the
prescribed pain medication and may adjust the dose or sort of analgesics.
Patients are advised to stay active and if possible return to work and/or their
leisure activities. They will receive information about the nature of their
symtoms/pain. The GP prescribes physical therapy which will consist of active
exercises to guide the patient in upgrading his or her activities according to
the agreed time schedule. Furthermore, the research nurse will offer counseling
by telephone throughout the study period. The protocol for the individual
exercise therapy supervised by a physical therapist will include education,
stretching, strengthening and conditioning exercises. Education in proper
posture, body mechanics for daily activities, and if necessary, the use of
orthopedic aids is essential to maintain the gains made through the physical
therapy sessions. The exercise therapy will be discontinued if, according to
the physical therapist, treatment goals have been achieved. The guide will be
time, not the intensity of the pain. If, six months after randomization, the
patient has still not improved or suffers from neurogenic complaints, surgical
treatment will be discussed with the patient.

Participation in this study imposes no additional risk to patients. Symptoms of
lumbar stenosis rarely progress to an acute medical condition (e.g. cauda
syndrome or marked or progressive paresis), requiring immediate surgery.
Throughout the study period the research nurse and general practitioner will
offer counseling and evaluate possible negative health effects of treatment
allocation. In case of adverse events related to treatment allocation, the
neurosurgeon will be informed. Participants allocated to the prolonged
conservative care group will be scheduled for secondary surgery if necessary.

Disadvantages of participating in this study are that subjects are required
additional visits to the outpatient clinic for follow-up examinations, intake
and randomization. Participants are requested to visit the outpatient clinic 7
times during a 5 year period. Regardles of pariticapating in this study, care
as usual also requires patients to make at least 2 visits to the outpatient
clinic.

Further, intermittent neurogenic claudication may persist or worsen with
prolonged conservative care, necessating secondary surgery. On the contrary,
surgery is made redundant in case of symptom relief among participants
allocated to prolonged conservative care.