Trigger Point Dry Needling With and Without Electrical Stimulation in Healthy Subjects (DN)

January 28, 2026 updated by: James Agostinucci, University of Rhode Island

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.

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 Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Kingston, Rhode Island, United States, 02881
        • Doctor of Physical Therapy, University of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius.
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.
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.
Other Names:
  • 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.
Other Names:
  • acupuncture
  • trigger point dry needling
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.
Other Names:
  • electrotherapy
  • neuromuscular electrical stimulation
  • electrostimulation
  • transcutaneous electrical nerve stimulation (TENS)
  • electrical muscle stimulation
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.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

This was a single time point study. Pain threshold was assessed before (baseline) and at 10 and 30 mins post treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: This was a single time point study. Muscle activity was assessed before (baseline) and at 10 and 30 mins post treatment.

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.

This was a single time point study. Muscle activity was assessed before (baseline) and at 10 and 30 mins post treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

April 20, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 3, 2026

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Subjects or Volunteers

Clinical Trials on Dry needling with electrical stimulation

Subscribe