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Clinical Trials/NCT05318729
NCT05318729
Not Yet Recruiting
N/A

Application of a Unique Vibration Modality for Postoperative Pain Control in Patients With Distal Radius Fractures to Reduce Postoperative Pain and Opioid Use

Northwestern University1 site in 1 country100 target enrollmentMarch 1, 2026

Overview

Phase
N/A
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
Northwestern University
Enrollment
100
Locations
1
Primary Endpoint
Pain Visual Analog Scale (VAS)
Status
Not Yet Recruiting
Last Updated
7 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2026
End Date
July 1, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Ko

Associate Professor

Northwestern University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain Visual Analog Scale (VAS)

Time Frame: up to 8 weeks post-surgery

Scored from 0 (no pain) to 10 (worst possible pain)

QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire

Time Frame: up to 8 week post-surgery

An 11-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb; scored from 0 (no disability) to 100 (most severe disability).

PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test

Time Frame: up to 8 weeks post-surgery

A 4-6 item self-reported questionnaire designed to measure the consequences of pain on relevant aspects of a person's life; the T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10; low scores represent less pain interference, while high scores represent greater interference.

PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test

Time Frame: up to 8 weeks post-surgery

A 4-6 item self-reported questionnaire designed to measure upper extremity function; the T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10; low scores represent less function, while high scores represent greater function.

Secondary Outcomes

  • Opioid Use(up to 8 weeks post-surgery)

Study Sites (1)

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