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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05318729
Enrollment
100
Registered
2022-04-08
Start date
2027-01-01
Completion date
2029-01-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture, Postoperative Pain, Radius Fracture Distal, Radius; Fracture, Lower or Distal End

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.

Interventions

DEVICEVibration 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.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaireup to 8 week post-surgeryAn 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 Testup to 8 weeks post-surgeryA 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 Testup to 8 weeks post-surgeryA 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-surgeryScored from 0 (no pain) to 10 (worst possible pain)

Secondary

MeasureTime frameDescription
Opioid Useup to 8 weeks post-surgeryNumber of opioid pain medication tablets consumed

Countries

United States

Contacts

CONTACTMelissa J Shauver, MPH
melissa.shauver@northwestern.edu312-472-6024
CONTACTSadie N Sial, BS
saadia.sial@northwestern.edu312-695-4463
PRINCIPAL_INVESTIGATORJason H Ko, MD, MBA

Associate Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026