Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures

NCT ID: NCT05318729

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-07-31

Brief Summary

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The purpose of this research study is to determine if using a vibration tool improves pain control after surgical treatment of distal radius fracture. Additionally, the investigators would like to determine if this tool has any impact on consumption of pain medications postoperatively.

Detailed Description

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Traditionally, occupational therapists have utilized vibration for sensory re-education in compression neuropathies and peripheral nerve injuries. Vibration is also commonly used for desensitization of hypersensitivity following amputation, crush injury, and for hypersensitive scarring. Since the vibration tool is readily available in the hand therapy clinic, vibration analgesia should be further explored in the hand clinic to help reduce pain. Vibration is a simple, and non-invasive, tool and would be easy, economical, and practical to implement into the hand clinic for postoperative pain control. This research project will evaluate whether vibration can be a useful adjunct to current postoperative pain modalities. With a multidisciplinary approach, the investigators hope to highlight the use of non-opioid modalities of pain control in distal radius fractures and believe that the findings from this study may apply to other painful conditions of the hand as well.

Conditions

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Distal Radius Fracture Radius Fracture Distal Radius; Fracture, Lower or Distal End Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vibration tool

Use of the vibration tool 3 times per day for 10 minutes for each session Morning, mid-day, and evening.

Volarly for 5 minutes and dorsally for 5 minutes, for a total of 10 minutes during each session:

Group Type EXPERIMENTAL

Vibration tool

Intervention Type DEVICE

Therapeutic mini massager for scar management, desensitization, muscle stimulation, oral stimulation and sensory re-education. Seek pain relief for sore achy muscles, tendons or bones.

Control

Standard of care, no vibration tool.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vibration tool

Therapeutic mini massager for scar management, desensitization, muscle stimulation, oral stimulation and sensory re-education. Seek pain relief for sore achy muscles, tendons or bones.

Intervention Type DEVICE

Other Intervention Names

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Norco NC70209 Mini Massager

Eligibility Criteria

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Inclusion Criteria

* Patients with a distal radius fracture who have undergone an open reduction and internal fixation using a volar FCR approach with a single volar plate
* Patients who can read, write, and follow direction in English
* Willing to undergo occupational therapy at Northwestern Medicine's Hand Surgery clinic

Exclusion Criteria

* Patients undergoing oncologic surgery
* Patients who undergo simultaneous surgery such as open carpal tunnel
* Patients who only require closed reduction of distal radius fractures
* Operative patients that require dorsal plate fixation or separate radial styloid plate fixation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Jason Ko

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason H Ko, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Northwestern Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

Central Contacts

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Melissa J Shauver, MPH

Role: CONTACT

312-472-6024

Sadie N Sial, BS

Role: CONTACT

312-695-4463

Facility Contacts

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Melissa J Shauver, MPH

Role: primary

312-475-6024

Sadie N Sial, BS

Role: backup

312-695-4463

Other Identifiers

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STU00214664

Identifier Type: -

Identifier Source: org_study_id

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