HealthyNCT04864704
Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants
A study testing dry needling in people with Healthy, run by Bradley University at 1 site in United States.
Trial summary
60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups. One session of dry needling DN was applied to the muscle in standardized location. Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2014to 30 Jan 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women ages 18 to 65 years
- reported good general health
- tenderness or palpable trigger point in the muscle (infraspinatus, gastrocnemius, or erector spinae)
Who cannot join
- BMI > 30kg/m2
- surgery in the prior 12 months
- current pain in the shoulder, low back, and lower leg
- precautions to dry needling treatment (anticoagulant medications, bleeding disorders, known pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups. One session of dry needling DN was applied to the muscle in standardized location. Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later. The presence of a localized twitch response (LTR) during DN was used to subgroup participants.
- Conditions
- Healthy
- Being tested
- dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingOther
Physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Infraspinatus | Active comparator | Subjects infraspinatus stiffness was measured and observed Receives: Other: dry needling |
| Erector spinae | Active comparator | Subjects erector spinae stiffness was measured and observed Receives: Other: dry needling |
| Gastrocnemius | Active comparator | Subjects gastrocnemius stiffness was measured and observed Receives: Other: dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stiffness
Biomechanical stiffness of the muscle measured, non-invasively using a MyotonPRO. Stiffness (N/m)
Measured: Change from baseline and immediately post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start30 Jan 2014
- Primary completion30 Jan 2015
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Kelly, Bradley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864704
- Sponsor's protocol ID
- BradleyU
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants
- ClinicalTrials.gov ID
- NCT04864704
- Acronym / sponsor ID
- BradleyU
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bradley UniversityUniversity, hospital or other
- Study start
- 30 Jan 2014 (actual)
- Primary completion
- 30 Jan 2015 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 29 Apr 2021 (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.
60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups. One session of dry needling DN was applied to the muscle in standardized location. Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later. The presence of a localized twitch response (LTR) during DN was used to subgroup participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infraspinatus | Active comparator | Other: dry needlingSubjects infraspinatus stiffness was measured and observed |
| Erector spinae | Active comparator | Other: dry needlingSubjects erector spinae stiffness was measured and observed |
| Gastrocnemius | Active comparator | Other: dry needlingSubjects gastrocnemius stiffness was measured and observed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women ages 18 to 65 years
- reported good general health
- tenderness or palpable trigger point in the muscle (infraspinatus, gastrocnemius, or erector spinae)
Key exclusion criteria (4 listed)
- BMI > 30kg/m2
- surgery in the prior 12 months
- current pain in the shoulder, low back, and lower leg
- precautions to dry needling treatment (anticoagulant medications, bleeding disorders, known pregnancy)
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 needlingPhysical therapy | Other | Erector spinae, Gastrocnemius, Infraspinatus |
Primary outcome
Change in Stiffness
Time frame: Change from baseline and immediately post intervention
Biomechanical stiffness of the muscle measured, non-invasively using a MyotonPRO. Stiffness (N/m)
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 29 Apr 2021.
- Individual participant dataSharing planned: No. Data will not be shared
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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 Healthy, run by Bradley 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: finished, as of the sponsor's last update on 29 Apr 2021. 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?
Change in Stiffness (time frame: Change from baseline and immediately post intervention). 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 29 Apr 2021.