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

NCT05318729 — Not applicable, Not yet recruiting, 100 participants, Northwestern University

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

RegistryNCT05318729
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment100 (Estimated)
SponsorNorthwestern University (Other)
ConditionsDistal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End, Postoperative Pain
InterventionsVibration tool (Device)
Datesstart 2027-01-01 (estimated), primary completion 2028-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2022-04-08, last updated 2026-07-10
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Distal Radius Fracture All trials for Radius Fracture Distal All trials of Vibration tool

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Vibration toolExperimentalDevice: Vibration toolUse 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:
ControlNo interventionStandard of care, no vibration tool.
  • Vibration tool (Device), also known as Norco NC70209 Mini Massager: 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.

+Outcome measures

Primary outcomes

  • 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.
  • Pain Visual Analog Scale (VAS) [up to 8 weeks post-surgery]: Scored from 0 (no pain) to 10 (worst possible pain)

Secondary outcomes

  • Opioid Use [up to 8 weeks post-surgery]: Number of opioid pain medication tablets consumed

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Northwestern MedicineChicago, IllinoisUnited States

+Investigators