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The Dutch Injection versus Surgery TRIal in Carpal Tunnel Syndrome patients

The Dutch Injection versus Surgery TRIal in Carpal Tunnel Syndrome patients - DISTRICTS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55537
Enrollment
940
Registered
2017-09-15
Start date
2017-11-06
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal tunnel syndrom

Interventions

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 consist

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)