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OpenTrials
Completed

NCT Number: NCT07384247

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

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.

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Key information

Conditions

People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles Complex Behavior Healthy Subjects or Volunteers Motor Activity

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doctor of Physical Therapy, University of Rhode Island

Kingston, Rhode Island, 02881, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry Needling with electrical stimulation

Procedure

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

dry needling

Procedure

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: trigger point dry needling, acupuncture

Electrical stimulation

Procedure

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, electrostimulation, electrical muscle stimulation, neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation (TENS)

Sham

Procedure

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

Primary outcomes

  1. 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).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Registry information

Official study title

Effect of Electrical Stimulation With Trigger Point Dry Needling on Pain and H-Reflex Muscle Activity

Acronym: DN

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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