People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles ComplexDNNCT07384247
Trigger Point Dry Needling With and Without Electrical Stimulation in Healthy Subjects
A study testing Dry needling with electrical stimulation, Dry needling and Electrical stimulation in people with People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex and Healthy Subjects or Volunteers, run by University of Rhode Island at 1 site in United States.
Trial summary
DN is one of the most commonly used physical therapy (PT) interventions for managing trigger points (Tp). Evidence suggests that DN was equally effective as other PT interventions, compared to no treatment or Sham-DN. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex, Healthy Subjects or Volunteers
- What is being tested?
- Dry needling with electrical stimulation, Dry needling and Electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2023to 30 Apr 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Age < 18 or > 55, able to communicate in English, no medical illness, or allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Doctor of Physical Therapy, University of Rhode Island
Kingston, Rhode Island, 02881
About this study
Official title: Effect of Electrical Stimulation With Trigger Point Dry Needling on Pain and H-Reflex Muscle Activity
DN is one of the most commonly used physical therapy (PT) interventions for managing trigger points (Tp). Evidence suggests that DN was equally effective as other PT interventions, compared to no treatment or Sham-DN. Electrical stimulation (ES) is also a commonly used non-invasive method for pain management during PT. Recently, several studies suggested that combining DN with ES may be more effective in trigger point release than DN alone. The goal of this clinical trial was to determine the effects that trigger point dry needling with and without electrical stimulation had on pain threshold. It would also learn about the effect the trigger point dry needling has on muscle activity in people with identified painful trigger points within the soleus and gastrocnemius muscle complex. The main questions it aims to answer are:
- In terms of trigger point pain threshold, is DN combined with ES superior to DN alone, ES alone, or Sham treatment?
- In terms of muscle activity, is DN with ES superior to DN only, ES only or Sham treatment? Researchers will compare dry needling with electrical stimulation, dry needling only, electrical stimulation only and a Sham treatment to see these interventions affect pain threshold and muscle activity.
Read more
Participants will:
- Randomly assigned as one of the four groups
- Visit the clinic once for test
- Receive permission and conduct intervention according to protocol.
- Conditions
- People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex, Healthy Subjects or Volunteers
- Being tested
- Dry needling with electrical stimulation, Dry needling, Electrical stimulation, Sham
- Keywords
- dry needling, electrical stimulation, H-reflex, motor activity, pain threshold, trigger point
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling with electrical stimulationProcedure or surgery
Also called electrical dry needling
A dry needle inserted into the trigger point and left in the muscle for 10 min. Also, parameters of electrical stimulation were set at a frequency of 30 Hz and a pulse width of 0.6 ms, at an intensity that caused a small muscle contraction.
Dry needlingProcedure or surgery
Also called trigger point dry needling, acupuncture
A dry needle inserted into the trigger point and left in the muscle for 10 min. To ensure uniformity in conditions across all groups, a placebo electrical stimulation protocol was implemented, characterized by the initiation of electrical stimulation followed by its immediate cessation.
Electrical stimulationProcedure or surgery
Also called electrotherapy, electrostimulation, electrical muscle stimulation, neuromuscular electrical stimulation
Electrical stimulation setting is same as above dry needling with electrical stimulation group while the needle touch the skin to cause a prick over the muscle and were held there for 10 min.
ShamProcedure or surgery
Also called placebo
The needle touches the skin to cause a prick over the muscle and were held there for 10 min (placebo dry needling) with placebo electrical stimulation which means initiating electrical stimulation but removing it instantaneously.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius. | Experimental | This study was a randomized controlled trial. Forty volunteers, aged 18-55 were recruited, signed an informed consent and randomly placed in four equal groups: dry needling with simultaneous electrical stimulation, dry needling only, electrical stimulation only, and a Sham treatment. Receives: Procedure: Dry needling with electrical stimulation; Procedure: Dry needling; Procedure: Electrical stimulation; Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effects that trigger point dry needling with and without electrical stimulation has on pain threshold
Primary outcome measure: when subjects perceived the intensity to be 50% of their maximum pain, based on a 1-10 analog pain scale.
Participants held a switch with a button connected to a Bluetooth-enabled PS 850 Data Log (Biometrics Ltd., UK) data acquisition software system, where all pain recordings were analyzed and stored. The pain threshold was measured three times and averaged. We also checked visual analogue scale (VAS).
Measured: This was a single time point study. Pain threshold was assessed before (baseline) and at 10 and 30 mins post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start2 Jan 2023
- Primary completion20 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles ComplexStudies 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
- randomized controlled study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Agostinucci, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384247
- Sponsor's protocol ID
- IRB 2122-042
- Other IDs
- IRB
- Acronym
- DN
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was completed two years ago and received Institutional Review Board (IRB) approval; however, I require this approval for the submission of an original article.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electrical Stimulation With Trigger Point Dry Needling on Pain and H-Reflex Muscle Activity
- ClinicalTrials.gov ID
- NCT07384247
- Acronym / sponsor ID
- DN / IRB 2122-042
- Conditions
- People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex, Healthy Subjects or Volunteers
- Keywords
- dry needling, electrical stimulation, H-reflex, motor activity, pain threshold, trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 3 Feb 2026 (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.
DN is one of the most commonly used physical therapy (PT) interventions for managing trigger points (Tp). Evidence suggests that DN was equally effective as other PT interventions, compared to no treatment or Sham-DN. Electrical stimulation (ES) is also a commonly used non-invasive method for pain management during PT. Recently, several studies suggested that combining DN with ES may be more effective in trigger point release than DN alone. The goal of this clinical trial was to determine the effects that trigger point dry needling with and without electrical stimulation had on pain threshold. It would also learn about the effect the trigger point dry needling has on muscle activity in people with identified painful trigger points within the soleus and gastrocnemius muscle complex. The main questions it aims to answer are:
- In terms of trigger point pain threshold, is DN combined with ES superior to DN alone, ES alone, or Sham treatment?
- In terms of muscle activity, is DN with ES superior to DN only, ES only or Sham treatment? Researchers will compare dry needling with electrical stimulation, dry needling only, electrical stimulation only and a Sham treatment to see these interventions affect pain threshold and muscle activity.
Participants will:
- Randomly assigned as one of the four groups
- Visit the clinic once for test
- Receive permission and conduct intervention according to protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius. | Experimental | Procedure: Dry needling with electrical stimulation, Procedure: Dry needling, Procedure: Electrical stimulation, Procedure: ShamThis study was a randomized controlled trial. Forty volunteers, aged 18-55 were recruited, signed an informed consent and randomly placed in four equal groups: dry needling with simultaneous electrical stimulation, dry needling only, electrical stimulation only, and a Sham treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Age < 18 or > 55, able to communicate in English, no medical illness, or allergies
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 needling with electrical stimulationAlso: electrical dry needlingA dry needle inserted into the trigger point and left in the muscle for 10 min. Also, parameters of electrical stimulation were set at a frequency of 30 Hz and a pulse width of 0.6 ms, at an intensity that caused a small muscle contraction. | Procedure or surgery | Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius. |
| Dry needlingAlso: trigger point dry needling, acupunctureA dry needle inserted into the trigger point and left in the muscle for 10 min. To ensure uniformity in conditions across all groups, a placebo electrical stimulation protocol was implemented, characterized by the initiation of electrical stimulation followed by its immediate cessation. | Procedure or surgery | Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius. |
| Electrical stimulationAlso: electrotherapy, electrostimulation, electrical muscle stimulation, neuromuscular electrical stimulationElectrical stimulation setting is same as above dry needling with electrical stimulation group while the needle touch the skin to cause a prick over the muscle and were held there for 10 min. | Procedure or surgery | Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius. |
| ShamAlso: placeboThe needle touches the skin to cause a prick over the muscle and were held there for 10 min (placebo dry needling) with placebo electrical stimulation which means initiating electrical stimulation but removing it instantaneously. | Procedure or surgery | Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius. |
Primary outcome
To determine the effects that trigger point dry needling with and without electrical stimulation has on pain threshold
Time frame: This was a single time point study. Pain threshold was assessed before (baseline) and at 10 and 30 mins post treatment.
Primary outcome measure: when subjects perceived the intensity to be 50% of their maximum pain, based on a 1-10 analog pain scale. Participants held a switch with a button connected to a Bluetooth-enabled PS 850 Data Log (Biometrics Ltd., UK) data acquisition software system, where all pain recordings were analyzed and stored. The pain threshold was measured three times and averaged. We also checked visual analogue scale (VAS).
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 3 Feb 2026.
- Individual participant dataSharing planned: No. This study was completed two years ago and received Institutional Review Board (IRB) approval; however, I require this approval for the submission of an original article.
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 with electrical stimulation, Dry needling and Electrical stimulation in people with People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex and Healthy Subjects or Volunteers, run by University of Rhode Island 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 0 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 3 Feb 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?
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?
To determine the effects that trigger point dry needling with and without electrical stimulation has on pain threshold (time frame: This was a single time point study. Pain threshold was assessed before (baseline) and at 10 and 30 mins post treatment.). 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 3 Feb 2026.