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

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05318729
Collaborator
(none)
100
1
2
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vibration tool
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vibration tool

Use 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:

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.
Other Names:
  • Norco NC70209 Mini Massager
  • No Intervention: Control

    Standard of care, no vibration tool.

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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.

    3. 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.

    4. Pain Visual Analog Scale (VAS) [up to 8 weeks post-surgery]

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

    Secondary Outcome Measures

    1. Opioid Use [up to 8 weeks post-surgery]

      Number of opioid pain medication tablets consumed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern Medicine Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Jason H Ko, MD, MBA, Associate Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Ko, Associate Professor, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT05318729
    Other Study ID Numbers:
    • STU00214664
    First Posted:
    Apr 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2022