Delayed Onset Muscle SorenessTDNDOMSNCT03876080
Dry Needling in Subjects With Delayed Onset Muscle Soreness
A study testing Dry needling in people with Delayed Onset Muscle Soreness, run by Bradley University at 1 site in United States.
Trial summary
Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Onset Muscle Soreness
- What is being tested?
- Dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2019to 23 May 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participants of the study will be any healthy male or female between
- age of 18 to 35
- able and willing to perform an exercise protocol using the gastrocnemius muscle
- willing to receive either sham or dry needling intervention
Who cannot join
- current muscular pain
- prior trigger point therapy in the past 6 months
- medications that affect muscle function
- injury in the past 6 months
- any health condition that prevents exercising
- recent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical Response to Dry Needling in Subjects With Delayed Onset Muscle Soreness: a Double Blind Randomized Control Trial
Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham
- Conditions
- Delayed Onset Muscle Soreness
- Being tested
- Dry needling, Sham needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
The use of a solid filiform needle to treat trigger points
Sham needlingOther
Simulated needling
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Dry needling intervention to the gastrocnemius muscle trigger point Receives: Other: Dry needling |
| Sham needling | Sham comparator | Sham dry needling intervention to the gastrocnemius muscle trigger point Receives: Other: Sham needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Biomechanical stiffness (N/m) using MyotonPRO
Measuring Biomechanical stiffness ( N/m) change at the following time frames
Measured: baseline, immediately after intervention, 24 hours after intervention
Secondary outcomes (1)
Change in Pressure pain threshold using pressure algometry
Measuring Pressure pain threshold change at the following time frames
Measured: baseline, immediately after intervention, 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start30 Mar 2019
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Onset 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 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
- NCT03876080
- Sponsor's protocol ID
- CUHSR 71-18
- Acronym
- TDNDOMS
- Status last verified
- Jul 2023
- First submitted
- 5 Feb 2019
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Response to Dry Needling in Subjects With Delayed Onset Muscle Soreness: a Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03876080
- Acronym / sponsor ID
- TDNDOMS / CUHSR 71-18
- Conditions
- Delayed Onset Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bradley UniversityUniversity, hospital or other
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 15 Mar 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.
Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingDry needling intervention to the gastrocnemius muscle trigger point |
| Sham needling | Sham comparator | Other: Sham needlingSham dry needling intervention to the gastrocnemius muscle trigger point |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The participants of the study will be any healthy male or female between
- age of 18 to 35
- able and willing to perform an exercise protocol using the gastrocnemius muscle
- willing to receive either sham or dry needling intervention
Key exclusion criteria (6 listed)
- current muscular pain
- prior trigger point therapy in the past 6 months
- medications that affect muscle function
- injury in the past 6 months
- any health condition that prevents exercising
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 needlingThe use of a solid filiform needle to treat trigger points | Other | Dry needling |
| Sham needlingSimulated needling | Other | Sham needling |
Primary outcome
Change in Biomechanical stiffness (N/m) using MyotonPRO
Time frame: baseline, immediately after intervention, 24 hours after intervention
Measuring Biomechanical stiffness ( N/m) change at the following time frames
1 secondary outcome
Change in Pressure pain threshold using pressure algometry
Time frame: baseline, immediately after intervention, 24 hours after intervention
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 27 Jul 2023.
- 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 Delayed Onset Muscle Soreness, 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 4 inclusion and 6 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 27 Jul 2023. 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. Some participants in this study may receive a placebo. 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 Biomechanical stiffness (N/m) using MyotonPRO (time frame: baseline, immediately after intervention, 24 hours after 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 27 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.