Distal Radius FractureNCT05318729
Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
A study testing Vibration tool in people with Distal Radius Fracture and Radius Fracture Distal, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End
- What is being tested?
- Vibration tool
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern Medicine
Chicago, Illinois, 60611
Melissa J Shauver, MPH, 312-475-6024, melissa.shauver@northwestern.edu
Sadie N Sial, BS, 312-695-4463, saadia.sial@northwestern.edu
About this study
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
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.
Read the 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.
- Conditions
- Distal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End, Postoperative Pain
- Being tested
- Vibration tool
- Medical subject headings
- Wrist Fractures, Fractures, Bone, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration toolDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Vibration tool | Experimental | 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: Receives: Device: Vibration tool |
| Control | No intervention | Standard of care, no vibration tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 8 week post-surgery
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.
Measured: up to 8 weeks post-surgery
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.
Measured: up to 8 weeks post-surgery
Pain Visual Analog Scale (VAS)
Scored from 0 (no pain) to 10 (worst possible pain)
Measured: up to 8 weeks post-surgery
Secondary outcomes (1)
Opioid Use
Number of opioid pain medication tablets consumed
Measured: up to 8 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Ko, Northwestern University
- Investigators
- Jason H Ko, MD, MBA, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318729
- Sponsor's protocol ID
- STU00214664
- Status last verified
- Jul 2026
- First submitted
- 8 Mar 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05318729
- Acronym / sponsor ID
- STU00214664
- Conditions
- Distal Radius Fracture, Radius Fracture Distal, Radius; Fracture, Lower or Distal End, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration tool | Experimental | Device: 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: |
| Control | No intervention | –Standard of care, no vibration tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration toolAlso: Norco NC70209 Mini MassagerTherapeutic mini massager for scar management, desensitization, muscle stimulation, oral stimulation and sensory re-education. Seek pain relief for sore achy muscles, tendons or bones. | Device | Vibration tool |
Primary outcome
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: up to 8 weeks post-surgery
Scored from 0 (no pain) to 10 (worst possible pain)
1 secondary outcome
Opioid Use
Time frame: up to 8 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason H Ko, MD, MBA principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration tool in people with Distal Radius Fracture and Radius Fracture Distal, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa J Shauver, MPH (312-472-6024, melissa.shauver@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire (time frame: up to 8 week post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.