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Splinting After Mini-Open Carpal Tunnel Release

A

Anthony L. Logli

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Other: Non-removable Splint
Other: Removable Splint
Other: No Splint

Study type

Interventional

Funder types

Other

Identifiers

NCT02885701
FWA00009558

Details and patient eligibility

About

The purpose of this study is to determine if any difference exists among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery.

Full description

We sought to determine if any significant difference in patient-reported or clinical outcomes existed among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery for symptomatic, isolated, nerve conduction study positive carpal tunnel syndrome (CTS).

A total of 249 patients received a mini-open CTR and were subsequently randomized into 1 of the 3 splinting regimens to be removed at the first postoperative visit 10-14 days later. Patient-reported outcomes included QuickDASH surveys, Levine-Katz Symptom Severity Scale (SSS) and Functional Status Scale (FSS) and Pain at Rest and in Action using a Numerical Pain Rating Scale (NPRS). Clinical outcomes included wrist range of motion (ROM), grip and lateral pinch strengths. All outcomes were evaluated bilaterally at 10-14 days, 6 weeks, 3 months, 6 months and 12 months after surgery. Demographic information was obtained preoperatively and complications were observed for and recorded throughout the study

Enrollment

249 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS.

Exclusion criteria

  • Exclusion criteria omitted patients who presented with acute onset CTS, concomitant peripheral neuropathy, metabolic disease, postoperative recurring CTS, or who required another operative procedure during carpal tunnel release.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

249 participants in 3 patient groups

No splint
Experimental group
Treatment:
Other: No Splint
Removable Splint
Experimental group
Treatment:
Other: Removable Splint
Non-removable Splint
Experimental group
Treatment:
Other: Non-removable Splint

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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