- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384247
Trigger Point Dry Needling With and Without Electrical Stimulation in Healthy Subjects (DN)
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
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Kingston, Rhode Island, United States, 02881
- Doctor of Physical Therapy, University of Rhode Island
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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:
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:
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:
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Motor Activity
- Investigative Techniques
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Analgesia
- Physical Stimulation
- salicylhydroxamic acid
- Dry Needling
- Acupuncture Therapy
- Transcutaneous Electric Nerve Stimulation
- Electric Stimulation
- Electric Stimulation Therapy
Other Study ID Numbers
- IRB 2122-042
- IRB (Other Identifier: University of Rhode Island)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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