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

NCT05318729 | Not Yet Recruiting FDA Device

• 1 other identifier: STU00214664
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Opioid Use

  up to 8 weeks post-surgery

Study Arms (2)

Vibration tool

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard of care, no vibration tool.

Interventions

Vibration tool 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.

Also known as: Norco NC70209 Mini Massager

Vibration tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Wrist Fractures; Fractures, Bone; Pain, Postoperative

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jason H Ko, MD, MBA

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa J Shauver, MPH

CONTACT

312-472-6024; melissa.shauver@northwestern.edu

Sadie N Sial, BS

CONTACT

312-695-4463; saadia.sial@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 8, 2022
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)