Muscle SorenessNCT03612843
Adverse Events in Dry Needling
An observational study of Muscle Soreness and Headache, run by Elizabeth Lane at 8 sites in United States.
Trial summary
The purpose of this prospective cohort survey study is to further explore the incidence of adverse events with dry needling by physical therapists - as well as any differences or similarities between patient-reported vs therapist-reported incidence of AEs. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Muscle Soreness, Headache, Knee Osteoarthritis
- What is being tested?
- Observational dry needle
- How many people
- 250 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Aug 2018to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient receiving DN as a regular part of their physical therapy care for any diagnosis.
Who may be able to join
- Any patient that receives dry needling as a part of their care by a physical therapist and consents to provide information
Who cannot join
- Does not receive dry needling or does not consent to provide information
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Benchmark Physical Therapy
Acworth, Georgia, 30101
Benchmark Physical Therapy
Athens, Tennessee, 37371
Benchmark Physical Therapy
Cartersville, Georgia, 30101
Benchmark Physical Therapy
Fort Oglethorpe, Georgia, 30707
Benchmark Physical Therapy
Hixson, Tennessee, 37415
Benchmark Physical Therapy
Kingsport, Tennessee, 37617
Benchmark Physical Therapy
Marietta, Georgia, 30008
Benchmark Physical Therapy
Roswell, Georgia, 30009
About this study
Official title: Clinician-Reported and Patient Reported Incidence of Mild and Significant Adverse Events Associated With Dry Needling by Physical Therapists
The purpose of this prospective cohort survey study is to further explore the incidence of adverse events with dry needling by physical therapists - as well as any differences or similarities between patient-reported vs therapist-reported incidence of AEs.
Read the detailed description
The study design will comprise of an observational study, where practicing clinicians will log data from dry needling sessions and patients will report via online surveys. Clinician logs will be collected weekly via an online REDCap survey . Patients will be instructed to complete an online REDCap survey in the event that an adverse event occurs. Data will be collected for a period of 4 mo.
Descriptive statistics will be used to calculate frequencies of various AE's and rates of occurrence per 100 treatments. Adverse events will be classified on how frequently they occur, ranging from very common (>1/10 treatments) to very rare (<1/10,000 treatments).
The investigators will then examine for differences between patient-reported and clinician-reported incidences and also explore for any correlations between adverse events and other various reported factors.
- Conditions
- Muscle Soreness, Headache, Knee Osteoarthritis, Back Pain, Neck Pain, Needle Stick
- Being tested
- Observational dry needle
- Keywords
- dry needling, adverse event, physical therapy
- Medical subject headings
- Myalgia, Headache, Osteoarthritis, Knee, Back Pain, Neck Pain, Needlestick Injuries, Shoulder Pain, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational dry needleOther
No intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Dry needle | Dry needling is provided as a part of a comprehensive treatment program by a physical therapist. The patient and the therapist will record any adverse events that occur. Receives: Other: Observational dry needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
adverse events are recorded by the patient and therapist
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Aug 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Lane
- Sponsor type
- University, hospital or other
- Collaborators
- Brenau University
- Responsible party
- Sponsor-investigator, Elizabeth Lane, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612843
- Sponsor's protocol ID
- UUtah
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinician-Reported and Patient Reported Incidence of Mild and Significant Adverse Events Associated With Dry Needling by Physical Therapists
- ClinicalTrials.gov ID
- NCT03612843
- Acronym / sponsor ID
- UUtah
- Conditions
- Muscle Soreness, Headache, Knee Osteoarthritis, Back Pain, Neck Pain, Needle Stick
- Keywords
- dry needling, adverse event, physical therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Elizabeth LaneUniversity, hospital or other
- Collaborators
- Brenau University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Aug 2018 (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 prospective cohort survey study is to further explore the incidence of adverse events with dry needling by physical therapists - as well as any differences or similarities between patient-reported vs therapist-reported incidence of AEs.
Detailed description
The study design will comprise of an observational study, where practicing clinicians will log data from dry needling sessions and patients will report via online surveys. Clinician logs will be collected weekly via an online REDCap survey . Patients will be instructed to complete an online REDCap survey in the event that an adverse event occurs. Data will be collected for a period of 4 mo.
Descriptive statistics will be used to calculate frequencies of various AE's and rates of occurrence per 100 treatments. Adverse events will be classified on how frequently they occur, ranging from very common (>1/10 treatments) to very rare (<1/10,000 treatments).
The investigators will then examine for differences between patient-reported and clinician-reported incidences and also explore for any correlations between adverse events and other various reported factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry needle | – | Other: Observational dry needleDry needling is provided as a part of a comprehensive treatment program by a physical therapist. The patient and the therapist will record any adverse events that occur. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient receiving DN as a regular part of their physical therapy care for any diagnosis.
Key inclusion criteria (1 listed)
- Any patient that receives dry needling as a part of their care by a physical therapist and consents to provide information
Key exclusion criteria (1 listed)
- Does not receive dry needling or does not consent to provide information
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 |
|---|---|---|
| Observational dry needleNo intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist. | Other | Dry needle |
Primary outcome
Adverse event
Time frame: 1 week
adverse events are recorded by the patient and therapist
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Muscle Soreness
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Mineral-Infused Clothing for Recovery From Muscle Soreness and Muscle Damage After Exercise
Delayed Onset Muscle Soreness, Exercise-Induced Muscle Damage
Not yet recruiting
Clinical and MRI Characteristics of Delayed Onset Muscle Soreness (DOMS) of the Shoulder Rotator Muscles Induced by Eccentric Exercise: An Exploratory Prospective Experimental Study
Delayed Onset Muscle Soreness Experimentally Induced
Recruiting
Effects of Kinesio Tape on Delayed Onset Muscle Soreness
Delayed Onset Muscle Soreness
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Soreness and Headache, run by Elizabeth Lane at 8 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: 1 week). 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 18 Apr 2019.