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

Not Applicable

Not yet recruiting

• Conditions: Radius Fracture Distal; Distal Radius Fracture; Radius; Fracture, Lower or Distal End; Postoperative Pain
• Interventions: Device: Vibration tool

• Registration Number: NCT05318729
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Study Start: 2025-03
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration tool	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:

Primary Outcome Measures

Name	Time	Method
Pain Visual Analog Scale (VAS)	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	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	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	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 Outcome Measures

Name	Time	Method
Opioid Use	up to 8 weeks post-surgery	Number of opioid pain medication tablets consumed

Trial Locations

Locations (1)

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States