An interventional study of Dry needling with electrical stimulation and Dry needling in People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex and Healthy Subjects or Volunteers, sponsored by University of Rhode Island. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by University of Rhode Island · Not applicable, Interventional, and Treatment
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:
Participants will:
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Inclusion Criteria: healthy volunteers with at least 2 ≥ identifiable trigger points in soleus or gastrocnemius
Exclusion Criteria:
Age \< 18 or > 55, able to communicate in English, no medical illness, or allergies
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.
Procedure: Dry needling with electrical stimulation · Procedure: Dry needling · Procedure: Electrical stimulation · Procedure: Sham
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.
Also known as: electrical dry needling
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.
Also known as: trigger point dry needling, acupuncture
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.
Also known as: electrotherapy, electrostimulation, electrical muscle stimulation, neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation (TENS)
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.
Also known as: placebo
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).
Time frame: This was a single time point study. Pain threshold was assessed before (baseline) and at 10 and 30 mins post treatment.
To investigate the effects that trigger point dry needling with and without electrical stimulation has on the muscle activity (H-reflex) within the soleus and gastrocnemius muscles
Other outcome measure: Muscle activity was assessed using the H-reflex technique when the H-reflex amplitude was 15-25% of Mmax (H25%). Surface electrodes were used to stimulate the tibial nerve and record the H-reflex data. The H-reflex was elicited by a 2.5 cm monopolar stimulating ball electrode placed on the skin over the tibial nerve in the popliteal fossa. Ten Mmax responses were recorded. The electrical intensity was then lowered such that the H-reflex amplitude was 15-25% of Mmax (H25%). Ten H25% responses were recorded, and their averages served as the baseline data.
Time frame: This was a single time point study. Muscle activity was assessed before (baseline) and at 10 and 30 mins post treatment.
Plan to share: 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.
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Rhode Island