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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibration tool

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Vibration toolExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
up to 8 week post-surgery
2

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.

Time frame
up to 8 weeks post-surgery
3

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.

Time frame
up to 8 weeks post-surgery
4

Pain Visual Analog Scale (VAS)

Scored from 0 (no pain) to 10 (worst possible pain)

Time frame
up to 8 weeks post-surgery

Secondary outcomes

1

Opioid Use

Number of opioid pain medication tablets consumed

Time frame
up to 8 weeks post-surgery

Other outcomes

Sponsors and contacts

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