Menu
Not yet recruiting NCT05318729

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

No phase Interventional Distal Radius Fracture Radius Fracture Distal Radius; Fracture, Lower or Distal End Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vibration tool.
Who it may be relevant to
Registry conditions: Distal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End, Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire [Time frame: up to 8 week post-surgery]
  • PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test [Time frame: up to 8 weeks post-surgery]
  • PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test [Time frame: up to 8 weeks post-surgery]
  • Pain Visual Analog Scale (VAS) [Time frame: up to 8 weeks post-surgery]
Secondary outcome measures (1)
  • Opioid Use [Time frame: up to 8 weeks post-surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern Medicine — Chicago

Identifiers

NCT: NCT05318729 · STU00214664

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗