Clinical trial NCT05318729: Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Radius Fracture Distal
Radius; Fracture, Lower or Distal End
Postoperative Pain
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire
timeFrame: up to 8 week post-surgery
measure: PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test
timeFrame: up to 8 weeks post-surgery
measure: PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test
timeFrame: up to 8 weeks post-surgery
measure: Pain Visual Analog Scale (VAS)
timeFrame: up to 8 weeks post-surgery
Secondary outcomes:
measure: Opioid Use
timeFrame: up to 8 weeks post-surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Associate Professor
name: Jason H Ko, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: