The objective of this study is to assess the efficacy and cost-effectiveness of a treatment strategy starting with surgical intervention compared to a starting treatment with steroid injection.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
if the treatment strategy starting with a surgical intervention results in a
higher recovery rate at 18 months follow-up compared to starting treatment with
a steroid injection.
Secondary outcome
A) time to recovery during 18 months of follow-up;
B) number of patients recovered at different time points during follow-up;
C) level of symptom severity at different time points during follow-up;
D) hand functioning at 18 months follow-up;
E) patient*s global perception of recovery at 18 months;
F) patient satisfaction at 18 months;
G) quality of life at 18 months;
H) number of additional treatments during follow-up;
I) number of adverse events during follow-up;
J) use of care and health-related costs during follow-up.
Background summary
Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy and is
characterized by pain, paresthesia, numbness, and weakness of the affected
hand. The cause of CTS is entrapment of the median nerve at the wrist. There
are no universally accepted criteria for diagnosing CTS. Electrodiagnostic
testing (EMG) and sonography are both accurate tools to confirm the diagnosis.
The overall prevalence rate of electrophysiological confirmed CTS in the
Netherlands is 9.2% in women and 0.6% in men. There are approximately 300,000
patients with CTS in the Netherlands. Estimated costs for absenteeism due to
CTS are 26,5 million euro/year. Treatment options for CTS include splinting,
steroid injections, and surgical decompression.
A systemic review suggested that surgical intervention is more effective than
non-surgical intervention for relieving symptoms of CTS. However, most
neurologists initiate treatment with steroid injections because they consider
this very easy to perform and relatively safe. Consequently, patients with mild
to moderate CTS are often treated first with one or two steroid injections. If
symptoms remain or reoccur, patients are referred for surgical intervention.
Because of the high frequency of persisting or reoccurring symptoms, this
strategy may result in an postponement of the more effective treatment, that
is, surgical intervention, which could lead to unnecessary health loss, work
absenteeism, and costs. Patients with severe CTS are often primarily treated
surgically, though the best treatment strategy is also not known.
The lack of comparative knowledge regarding the best treatment strategy for
CTS, that is, starting with a surgical intervention or starting treatment with
a steroid injection is reflected in the concept CBO-guideline for CTS (2016),
which states no preference for one of the strategies. All of the above
contributes to the considerable practice variation in the treatment of CTS.
Study objective
The objective of this study is to assess the efficacy and cost-effectiveness of
a treatment strategy starting with surgical intervention compared to a starting
treatment with steroid injection.
Study design
The study is a multicenter open-label randomized controlled trial. The
inclusion period will be 18 months. The follow-up of each patient is 18 months
from randomization. The approximately 30 participating centers will be
recruited from university medical centers, STZ -hospitals (Stichting
Topklinische Ziekenhuizen), general hospitals, and ZBC*s (Zelfstandig
behandelcentra) in the Netherlands.
Intervention
Patients will be randomly assigned to two treatment strategies. One strategy
consists of starting with a steroid injection proximal to the carpal tunnel
(injection group). The other strategy consists of starting with a surgical
intervention (surgery group). If needed, these treatments can be followed by
additional treatments such as a second injection or surgical intervention.
Independent of the initial treatment performed, patients will receive the usual
care at the discretion of their physician.
Study burden and risks
Both surgical intervention as well as steroid injections for the treatment of
CTS have been widely used treatments which are in itself, not innovative and
low complex, therefore patients will not be exposed to additional risks. The
exclusion criteria which exclude diseases which can mimic carpal tunnel
syndrome prevent patient from being submitted to a treatment which they do not
need. To summarize, the risk of this trial is considered negligible.
Meibergdreef 9 Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9 Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older at time of examination;
- clinically suspected CTS;
- symptoms being present for at least 6 weeks;
- electrophysiological or sonographic confirmed CTS according to the Dutch
*carpal tunnel syndrome guideline**;
- treatment within 6 weeks after inclusion.
- the patient can only be included for the treatment of one hand if both hands
are eligible; this will be the hand with the most severe complaints or the
dominant hand if both hands are equally affected.
- surgery and injection are both considered as potential treatments for the CTS
related symptoms**., * There is no consensus about findings with sonography in
CTS. The current opinion of the DUTCH CTS study group is that a CSA of more
than 11 mm2 is abnormal and thus confirms a clinical suspicion of CTS., **
Patients with secondary CTS due to a known underlying cause including, but not
limited to: diabetes mellitus, rheumatoid arthritis, thyroid disease and a
history of ipsilateral wrist fracture/trauma or surgery are allowed to
participate in the DISTRICTS. This only if the treating physician considers
both surgery and injection as effective treatments.
Exclusion criteria
- follow-up not possible;
- a previous history of surgery for CTS on the ipsilateral wrist;
- an injection for CTS in the ipsilateral wrist less than one year ago;
- previously participating in the DISTRICTS;
- clinical or neurophysiological suggestion of another diagnosis that can
influence CTS, like:
- cervical radiculopathy;
- cervical myelopathy;
- brachial plexopathy including thoracic outlet syndrome;
- mononeuropathies, such as pronator teres syndrome;
- polyneuropathy, incl. Hereditary Neuropathy with Liability to Pressure
Palsies;
- complex regional pain syndrome.
- unable to comprehend Dutch self-report questionnaires;
- legally incompetent adults;
- no informed consent;
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61506.018.17 |