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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Distal Radius Fracture; Radius Fracture Distal; Radius; Fracture, Lower or Distal End
• Intervention / Treatment: Device: Vibration tool

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa J Shauver, MPH; Phone Number: 312-472-6024; Email: melissa.shauver@northwestern.edu
• Study Contact Backup: Name: Sadie N Sial, BS; Phone Number: 312-695-4463; Email: saadia.sial@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
      • Contact: Sadie N Sial, BS; Phone Number: 312-695-4463; Email: saadia.sial@northwestern.edu
      • Contact: Melissa J Shauver, MPH; Phone Number: 312-475-6024; Email: melissa.shauver@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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:	Device: 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.; Other Names: Norco NC70209 Mini Massager
No Intervention: Control; Standard of care, no vibration tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire	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).	up to 8 week post-surgery
PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test	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.	up to 8 weeks post-surgery
PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test	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.	up to 8 weeks post-surgery
Pain Visual Analog Scale (VAS)	Scored from 0 (no pain) to 10 (worst possible pain)	up to 8 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Number of opioid pain medication tablets consumed	up to 8 weeks post-surgery

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jason H Ko, MD, MBA, Associate Professor

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Pain, Postoperative; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: STU00214664

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No