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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05318729
• Other study ID #: STU00214664
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2025
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Melissa J Shauver, MPH
• Phone: 312-472-6024
• Email: melissa.shauver[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Pain, Postoperative
• Postoperative Pain
• Radius Fracture Distal
• Radius Fractures
• Radius; Fracture, Lower or Distal End
• Wrist Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Pain Visual Analog Scale (VAS)	Scored from 0 (no pain) to 10 (worst possible pain)	up to 8 weeks post-surgery
Secondary	Opioid Use	Number of opioid pain medication tablets consumed	up to 8 weeks post-surgery