Dry NeedlingNCT04040218
Trigger Point Dry Needling Practice in Colorado: Practitioner and Patient
A study testing Dry Needling in people with Dry Needling and Harm, run by Regis University at 1 site in United States.
Trial summary
A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Needling, Harm
- What is being tested?
- Dry Needling
- Type of treatment
- Surgery or procedure
- How many people
- 2,607 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 30 Apr 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physical therapists providing dry needling to patients in Colorado
- Patients who had received dry needling from Physical Therapists in Colorado
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harms Associated With Dry Needling Provided During Patient Care in Colorado by Physical Therapists
A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO
Read the detailed description
Two surveys were completed to identify the reported harms by physical therapists in the provision of dry needling in Colorado, and by patients who received dry needling from physical therapists in Colorado in April 2017. Retrospective analysis of the data (de-identified) was completed to provide a representative reporting on harms associated with the dry needling provided and received for patients.
- Conditions
- Dry Needling, Harm
- Being tested
- Dry Needling
- Keywords
- dry needling, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Dry needling is utilized by multiple practitioners to address impairments in neuromusculoskeletal function, often related to pain and loss of mobility. Dry needling, according the American Physical Therapy Association (APTA), is defined as a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey analysis of harm data
Harm - "any ill-effect, no matter how small, that was unintended." Further delineation was made that minor/insignificant complaints/harms were defined as short term soreness less than 24 hours and more than 24 hours, bruising and light-headedness, and major/significant harm was defined infection or pneumothorax (PTX).
Measured: As reported during the four week survey time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Apr 2017
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry NeedlingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The target population for this study was a representative sample of PT providers that administer and patients that receive dry needling as a treatment modality in the state of Colorado. 440 PT's licensed in Colorado and 2167 patients were recruited for this study. Purposive sampling was implemented through convenience sampling methods; by which PT respondents were included through their association to APTA CO or Kinetacore@ (an education provider in DN) and patients through their PT provider. The PT survey was sent out to APTA CO members and via a Kinetacore email list; which included approximately 900 individuals trained by Kinetacore in CO. All respondents to the PT survey were requested to provide patients with a direct link to the patient survey. Invitation was promoted by APTA CO outside of their member portal to non-members and word of mouth was encouraged.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040218
- Sponsor's protocol ID
- 1069837-1
- Status last verified
- Jul 2019
- First submitted
- 30 Jul 2019
- Last updated
- 31 Jul 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 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harms Associated With Dry Needling Provided During Patient Care in Colorado by Physical Therapists
- ClinicalTrials.gov ID
- NCT04040218
- Acronym / sponsor ID
- 1069837-1
- Conditions
- Dry Needling, Harm
- Keywords
- dry needling, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,607 participants (actual)
- Lead sponsor
- Regis UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 31 Jul 2019 (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.
A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO
Detailed description
Two surveys were completed to identify the reported harms by physical therapists in the provision of dry needling in Colorado, and by patients who received dry needling from physical therapists in Colorado in April 2017. Retrospective analysis of the data (de-identified) was completed to provide a representative reporting on harms associated with the dry needling provided and received for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Model description
- The target population for this study was a representative sample of PT providers that administer and patients that receive dry needling as a treatment modality in the state of Colorado. 440 PT's licensed in Colorado and 2167 patients were recruited for this study. Purposive sampling was implemented through convenience sampling methods; by which PT respondents were included through their association to APTA CO or Kinetacore@ (an education provider in DN) and patients through their PT provider. The PT survey was sent out to APTA CO members and via a Kinetacore email list; which included approximately 900 individuals trained by Kinetacore in CO. All respondents to the PT survey were requested to provide patients with a direct link to the patient survey. Invitation was promoted by APTA CO outside of their member portal to non-members and word of mouth was encouraged.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physical therapists providing dry needling to patients in Colorado
- Patients who had received dry needling from Physical Therapists in Colorado
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Dry NeedlingDry needling is utilized by multiple practitioners to address impairments in neuromusculoskeletal function, often related to pain and loss of mobility. Dry needling, according the American Physical Therapy Association (APTA), is defined as a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments | Procedure or surgery | – |
Primary outcome
Survey analysis of harm data
Time frame: As reported during the four week survey time frame
Harm - "any ill-effect, no matter how small, that was unintended." Further delineation was made that minor/insignificant complaints/harms were defined as short term soreness less than 24 hours and more than 24 hours, bruising and light-headedness, and major/significant harm was defined infection or pneumothorax (PTX).
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 31 Jul 2019.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Dry Needling and Harm, run by Regis 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 2 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 31 Jul 2019. 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?
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?
Survey analysis of harm data (time frame: As reported during the four week survey time frame). 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 31 Jul 2019.