Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
Primary Purpose
Distal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibration tool
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture
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
Sites / Locations
- Northwestern Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vibration tool
Control
Arm Description
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:
Standard of care, no vibration tool.
Outcomes
Primary Outcome Measures
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).
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.
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.
Pain Visual Analog Scale (VAS)
Scored from 0 (no pain) to 10 (worst possible pain)
Secondary Outcome Measures
Opioid Use
Number of opioid pain medication tablets consumed
Full Information
NCT ID
NCT05318729
First Posted
March 8, 2022
Last Updated
February 2, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05318729
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End, Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vibration tool
Arm Type
Experimental
Arm Description
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:
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care, no vibration tool.
Intervention Type
Device
Intervention Name(s)
Vibration tool
Other Intervention Name(s)
Norco NC70209 Mini Massager
Intervention Description
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.
Primary Outcome Measure Information:
Title
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire
Description
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
Title
PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test
Description
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
Title
PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test
Description
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
Title
Pain Visual Analog Scale (VAS)
Description
Scored from 0 (no pain) to 10 (worst possible pain)
Time Frame
up to 8 weeks post-surgery
Secondary Outcome Measure Information:
Title
Opioid Use
Description
Number of opioid pain medication tablets consumed
Time Frame
up to 8 weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa J Shauver, MPH
Phone
312-472-6024
Email
melissa.shauver@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sadie N Sial, BS
Phone
312-695-4463
Email
saadia.sial@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason H Ko, MD, MBA
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa J Shauver, MPH
Phone
312-475-6024
Email
melissa.shauver@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Sadie N Sial, BS
Phone
312-695-4463
Email
saadia.sial@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
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