- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672093
Effects of Dry Needling on Latent Myofascial Trigger Points of the Extensor Digitorum Communis: a Randomized Clinical Trial. (DRYNEED)
Effects of Dry Needling and Dry Electroacupuncture on Latent Myofascial Trigger Points of the Extensor Digitorum Communis: a Randomized Clinical Trial.
This randomized single-blind clinical trial aims to compare the effects of different dry needling and electrical dry needling techniques applied to latent myofascial trigger points in the extensor digitorum muscle of the dominant forearm in healthy adults.
Participants will be randomly allocated to one of five groups: a control group, a Hong fast-in and fast-out dry needling group, a rotational dry needling group, a bipolar electrical dry needling group, or a monopolar electrical dry needling group. The main outcomes will be post-needling soreness intensity and duration. Secondary outcomes will include pain during the needling procedure, pressure pain threshold assessed by algometry, handgrip strength, range of motion of finger flexion and wrist palmar flexion, perceived comfort during the intervention, and perceived interference of post-needling soreness with daily activities.
Assessments will be performed at baseline, 5 minutes after the intervention, and at 24, 48, and 72 hours after the intervention.
Study Overview
Status
Detailed Description
Myofascial trigger points are hyperirritable spots located within a taut band of skeletal muscle. Latent myofascial trigger points do not cause spontaneous pain but may contribute to motor dysfunction, increased fatigability, reduced range of motion, and altered muscle performance. Dry needling is a commonly used physiotherapy technique for the treatment of myofascial trigger points. However, post-needling soreness is one of the most frequent adverse effects associated with this intervention and may influence patient comfort, adherence, and functional performance in the hours following treatment.
Electrical dry needling, also known as intramuscular electrical stimulation, combines dry needling with transcutaneous electrical nerve stimulation applied through the inserted needle. Different modalities of electrical dry needling are used in clinical practice, including bipolar and monopolar applications. Nevertheless, limited evidence is available regarding the effect of these techniques on post-needling soreness, particularly when short-duration monopolar stimulation is applied using a pointer-type device.
The aim of this randomized single-blind clinical trial is to compare the effects of different dry needling and electrical dry needling techniques applied to latent myofascial trigger points in the extensor digitorum muscle of the dominant forearm in healthy adults. The primary objective is to compare the effect of electrical dry needling versus Hong fast-in and fast-out dry needling on the intensity and duration of post-needling soreness. Secondary objectives include comparing post-needling soreness among the different dry needling techniques, analyzing immediate changes in handgrip strength, assessing changes in finger flexion and wrist palmar flexion range of motion, evaluating pain during the needling procedure, assessing pressure pain threshold by algometry, and analyzing perceived comfort and interference of post-needling soreness with daily activities.
Healthy adults with a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm will be recruited. Participants will be randomly assigned to one of five groups: control group, Hong fast-in and fast-out dry needling group, rotational dry needling group, bipolar electrical dry needling group, or monopolar electrical dry needling group. Participants in the control group will not receive any dry needling intervention but will undergo the same assessment schedule as the intervention groups.
In the Hong fast-in and fast-out dry needling group, a sterile needle will be inserted into the latent myofascial trigger point and repeated fast-in and fast-out movements will be performed. In the rotational dry needling group, a sterile needle will be inserted into the latent myofascial trigger point and a rotational dry needling technique will be applied according to the study protocol. In the bipolar electrical dry needling group, a sterile needle will be inserted into the latent myofascial trigger point, an adhesive electrode will be placed near the needle, and a TENS current will be applied for 15 minutes. In the monopolar electrical dry needling group, a sterile needle will be inserted into the latent myofascial trigger point and stimulation will be applied using a Pointer Plus Excel-II device for 3 minutes.
Outcome assessments will be performed at baseline and 5 minutes after the intervention. Post-needling soreness intensity and duration will also be recorded at 24, 48, and 72 hours after the intervention. The study will use separated roles for recruitment, assessment, intervention delivery, and data analysis in order to reduce bias. Outcome assessors and the researcher responsible for data analysis will be blinded to group allocation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tania López Hernández, Phd
- Phone Number: 34+620438175
- Email: tania.lopez@urv.cat
Study Locations
-
-
Tarragona
-
Reus, Tarragona, Spain, 43203
- Recruiting
- Facultat de Medicina i Ciències de la Salut
-
Contact:
- Tania López Hernández, Phd
- Phone Number: 34+620438175
- Email: tania.lopez@urv.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 to 40 years.
- Healthy participants with a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
- No pathology affecting the upper limb where the intervention will be applied.
- No episode of pain in the upper limb during at least the previous two months.
- No contraindications to dry needling or electrical dry needling techniques.
- Voluntary signature of the informed consent form.
- Willingness to follow the protocol proposed by the research team.
Exclusion Criteria:
- Needle phobia.
- Coagulation disorders.
- Pregnancy.
- Thyroid disorders.
- Altered skin integrity in the treatment area.
- Epilepsy.
- Local or systemic infection.
- Diagnosed neurological disorders affecting pain perception or neuromuscular function in the region of interest, such as multiple sclerosis or peripheral neuropathies.
- Generalized chronic pain conditions, such as fibromyalgia.
- Weekly use of analgesic medication, including anti-inflammatory drugs, opioids, or other pain-relieving medication.
Withdrawal Criteria:
- Lack of participant collaboration.
- Failure to complete follow-up assessments after the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention: Control Group
Participants allocated to the control group will not receive any dry needling or electrical dry needling intervention.
Outcome variables will be recorded following the same assessment schedule as in the intervention groups.
|
|
|
Experimental: Experimental: Hong Fast-In and Fast-Out Dry Needling Group
Participants allocated to this group will receive dry needling using the fast-in and fast-out technique described by Hong, applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
|
The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once the needle has reached the trigger point, 10 fast-in and fast-out movements will be performed.
The number of local twitch responses will be recorded.
|
|
Experimental: Experimental: Rotational Dry Needling Group
Participants allocated to this group will receive dry needling using a rotational technique applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
|
The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once the needle has reached the trigger point, the rotational dry needling technique will be applied according to the predefined study protocol.
|
|
Experimental: Experimental: Bipolar Electrical Dry Needling Group
Participants allocated to this group will receive bipolar electrical dry needling applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
|
The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once a local twitch response has been obtained, the needle will remain inserted and will act as the negative pole.
An adhesive electrode connected to the positive pole will be placed approximately one centimeter from the needle.
A TENS current will be applied for 15 minutes at a frequency of 2 Hz and a pulse width of 120 milliseconds.
The intensity will be increased until visible, non-painful contractions of the extensor digitorum muscle are achieved.
|
|
Experimental: Experimental: Monopolar Electrical Dry Needling Group
Participants allocated to this group will receive monopolar electrical dry needling using a Pointer device, applied to a latent myofascial trigger point in the extensor digitorum muscle of the dominant forearm.
|
The skin will be disinfected with 0.5% alcoholic chlorhexidine.
With the participant in supine position, a sterile needle will be inserted into the latent myofascial trigger point of the extensor digitorum muscle.
Once a local twitch response has been obtained, the needle will remain inserted in the trigger point.
The metallic tip of the Pointer Plus Excel-II device will be placed in contact with the needle, and a TENS current will be applied for 3 minutes at a frequency of 2 Hz and a pulse width of 220 milliseconds.
The intensity will be increased until visible, non-painful contractions of the extensor digitorum muscle are achieved.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-needling soreness intensity
Time Frame: 1 week
|
Post-needling soreness intensity will be assessed using a numerical pain rating scale.
Participants will rate the intensity of local soreness perceived in the needling area, clearly differentiated from any other type of pain.
Higher scores indicate greater pain intensity.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of post-needling soreness
Time Frame: 1 week
|
The duration of post-needling soreness will be recorded in hours, from the moment of onset until complete disappearance, based on participant self-report during the 24-, 48-, and 72-hour follow-up assessments.
|
1 week
|
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Pain during needling
Time Frame: Inmmediatly
|
Pain perceived during the application of the dry needling or electrical dry needling technique will be assessed using a numerical pain rating scale.
Participants will be asked to report the intensity of pain experienced during the procedure.
|
Inmmediatly
|
|
Pressure pain threshold
Time Frame: 1 week
|
Pressure pain threshold will be assessed using pressure algometry over the treated region.
The value will be recorded as the minimum pressure that induces the first sensation of pain.
|
1 week
|
|
Handgrip strength
Time Frame: 1 week
|
Handgrip strength will be assessed using a hand dynamometer and recorded in kilograms.
Measurements will be performed before the intervention and 5 minutes after the intervention to evaluate immediate changes, also a week before.
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1 week
|
|
Range of motion of finger flexion and wrist palmar flexion
Time Frame: 1 week
|
Range of motion of finger flexion and wrist palmar flexion will be assessed using a two-arm goniometer and recorded in degrees.
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tania López Hernández, Unviersitat Rovira i Virgili
Publications and helpful links
General Publications
- Gallagher EJ, Liebman M, Bijur PE. Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8. doi: 10.1067/mem.2001.118863.
- Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.
- Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- Leon-Hernandez JV, Martin-Pintado-Zugasti A, Frutos LG, Alguacil-Diego IM, de la Llave-Rincon AI, Fernandez-Carnero J. Immediate and short-term effects of the combination of dry needling and percutaneous TENS on post-needling soreness in patients with chronic myofascial neck pain. Braz J Phys Ther. 2016 Jul 11;20(5):422-431. doi: 10.1590/bjpt-rbf.2014.0176.
- Fernandez-de-Las-Penas C, Dommerholt J. International Consensus on Diagnostic Criteria and Clinical Considerations of Myofascial Trigger Points: A Delphi Study. Pain Med. 2018 Jan 1;19(1):142-150. doi: 10.1093/pm/pnx207.
- Perreault T, Ball A, Dommerholt J, Theiss R, Fernandez-de-Las-Penas C, Butts R. Intramuscular Electrical Stimulation to Trigger Points: Insights into Mechanisms and Clinical Applications-A Scoping Review. J Clin Med. 2022 Oct 13;11(20):6039. doi: 10.3390/jcm11206039.
- Martin-Pintado-Zugasti A, Mayoral Del Moral O, Gerwin RD, Fernandez-Carnero J. Post-needling soreness after myofascial trigger point dry needling: Current status and future research. J Bodyw Mov Ther. 2018 Oct;22(4):941-946. doi: 10.1016/j.jbmt.2018.01.003. Epub 2018 Jan 17.
- Brady S, McEvoy J, Dommerholt J, Doody C. Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. J Man Manip Ther. 2014 Aug;22(3):134-40. doi: 10.1179/2042618613Y.0000000044.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 06/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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