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

NCT07384247 | Completed

• 2 other identifiers: IRB 2122-042IRB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

dry needling; electrical stimulation; H-reflex; motor activity; pain threshold; trigger point

Outcome Measures

Primary Outcomes (1)

• 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).

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

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

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

Study Arms (1)

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.

Procedure: Dry needling with electrical stimulation; Procedure: Dry needling; Procedure: Electrical stimulation; Procedure: Sham

Interventions

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.

Also known as: electrical dry needling

Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius.

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.

Also known as: trigger point dry needling, acupuncture

Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius.

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.

Also known as: electrotherapy, electrostimulation, electrical muscle stimulation, neuromuscular electrical stimulation, transcutaneous electrical nerve stimulation (TENS)

Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius.

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.

Also known as: placebo

Healthy subjects who has identified painful trigger points within the soleus and gastrocnemius.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Age \< 18 or \> 55, able to communicate in English, no medical illness, or allergies

Sponsors & Collaborators

• University of Rhode Island: lead

Study Sites (1)

Doctor of Physical Therapy, University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Dry Needling; Electric Stimulation; Acupuncture Therapy; Electric Stimulation Therapy; Transcutaneous Electric Nerve Stimulation; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Physical Stimulation; Investigative Techniques; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Sc.D., OTR/L

Model Details: randomized controlled study

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 3, 2026
• Study Start: January 2, 2023
• Primary Completion: April 20, 2023
• Study Completion: April 30, 2023
• Last Updated: February 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)