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Dry Needling TechniqueNCT06705634

How Dry Needling at the Neck Affects Shoulder Movement, Strength, Pain, and Shoulder Circulation

A study testing Dry Needling in people with Dry Needling Technique and Neck Pain Musculoskeletal, run by Texas Woman's University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Segmental facilitation, originally proposed by Korr in the 1950s, suggests that certain spinal segments can become hyperexcitable, leading to chronic pain development. In a facilitated segment, neurons governing sensory, motor, and autonomic functions are in a state of heightened sensitivity, making them responsive to… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Dry Needling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Dec 2024to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults 18-65 years of age
  • non-specific neck-shoulder pain (over the upper trapezius or the infraspinatus area) with an average pain ≥ 2/10 on the Numeric Pain Rating Scale (score range from 0-10, 0 = no pain, 10 = unbearable pain)
  • at least one tender point in one of the 5 muscles: cervical paraspinal near C5-C6 spinal segment, rhomboids, supraspinatus, infraspinatus, and deltoid.

Who cannot join

  • Participants will be excluded from this study if they have a contraindication to dry needling or a medical condition affecting blood flow, including but not limited to:
  • Active systemic arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
  • Traumatic brain injury
  • Stroke Seizures/epilepsy
  • Neurological disease (e.g., multiple sclerosis, muscular dystrophy, Parkinson's, spinal cord compression)
  • Acute or History of Fracture of cervical spine
Show all 16Show fewer
  • Acute or History of Fracture of the shoulder
  • Circulation/vascular problems (e.g., Raynaud's)
  • Cancer
  • Uncontrolled diabetes/high blood sugar
  • Currently pregnant
  • Previous neck surgery
  • Previous arthroscopic shoulder surgery in the last 5 years
  • Previous shoulder arthoplasty
  • Taking an anticoagulant (blood thinner)
  • Allergic to ultrasound gel

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Woman's University T. Boone Pickens Institute of Health Sciences

    Dallas, Texas, 75235

Other trials in United States

About this study

Official title: Effects of Dry Needling of C5-C6 on Shoulder Range of Motion, Strength, Tender Points, and Blood Flow

Segmental facilitation, originally proposed by Korr in the 1950s, suggests that certain spinal segments can become hyperexcitable, leading to chronic pain development. In a facilitated segment, neurons governing sensory, motor, and autonomic functions are in a state of heightened sensitivity, making them responsive to normally weak stimuli. Clinical signs include non-fatigable muscle weakness, brisk reflexes, muscle hypertonicity, tenderness upon palpation, and trophic changes like an orange-peel appearance in the affected segment's innervated areas. It's hypothesized that increased synaptic excitability in facilitated segments could cause vasoconstriction and reduced blood flow, contributing to trophic changes and muscle hypertonicity.

Manual therapies like dry needling have been shown to alleviate muscle inhibition in the extremities. Previous studies have demonstrated that mobilization of the C5-6 joint can reduce non-fatigable weakness in shoulder external rotators primarily innervated by these segments. However, the neurophysiological effects of dry needling (DN) on muscle inhibition due to a facilitated segment remain unclear. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain.

Therefore, this project aims to investigate whether DN applied at a facilitated segment could normalize blood flow to its associated muscles. Specifically, this study will explore whether DN at the C5-6 level improves blood flow in the infraspinatus muscle, enhances shoulder range of motion, and influences muscle strength over time. The secondary purpose is to determine whether C5-6 DN will reduce the number of tender points in the muscles supplied by C5-6.

Read the detailed description

All participants are required to attend 1 on-site visit (~ 1.25-1.5 hours) at the study site (TWU). The procedures of this research study are described in the following:

  1. Administration of the Consent Form, Intake Form, and Questionnaires At the beginning of the on-site visit, one investigator, depending on the study site and availability of the investigators, will describe the study purpose/procedures as well as the risks/benefits associated with this study to each participant. Once the participant agrees to participate in this study, the participant will be asked to sign the written consent form. Next, the participant will complete an intake form (see below and Section 9) for their demographic information and the history of their neck-shoulder pain. Each participant also will complete 3 questionnaires: (1) Brief Pain Index (BPI), (2) Quick Disability of Arm, Shoulder, and Hand Questionnaire (QuickDASH), and (3) Central Sensitization Inventory (CSI). These forms will be delivered online via Google form, or on paper if the participant prefers. These 3 questionnaires will provide information on each participant's neck-shoulder pain, function level, and degree of central sensitization/segmental facilitation. The BPI (see Section 9) is a 9-item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The QuickDash is a self-report questionnaire (see Section 9) used to determine how shoulder pain affects a patient's daily life and to assess the self-rated disability of patients with shoulder pain. The CSI consists of two parts: Part A is a 25-item self-report questionnaire designed to identify patients who have symptoms that may be related to central sensitization. Part B asks patients whether they have been diagnosed with 10 central sensitization syndromes, such as fibromyalgia, whiplash, and migraine.
  2. Palpation Assessment for Presence of Tenderness During this palpation assessment, the participants will lie prone with their arms at their sides. The investigator will palpate for tender points at the following muscle groups innervated by C5-C6 to determine eligibility: (1) Cervical paraspinals at C5-6 segment, (2) rhomboids near the spine of the scapula, (3) supraspinatus muscle belly, (4) the middle of the infraspinatus muscle belly, (5) middle deltoid. A skin marker will be used to mark these 4 sites so that the investigator can assess the same locations during the re-assessments.
  3. Pre-intervention Assessments After gathering the subjective information and confirming the eligibility of the participant, the 3 outcome measures will be collected. The outcome measures will be collected in the following order to minimize position changes that could impact blood flow: (1) blood flow parameters in prone, (2) Shoulder range of motion (ROM), (3) Shoulder external rotation strength in supine.
  • Shoulder ROM Testing: ROM testing will be performed while the participant is lying supine with the shoulder at 90° abduction and 10° of horizontal abduction and elbow at 90°flexion. The center of rotation of the goniometer will be placed over the olecranon while one arm of the goniometer will be positioned along the length of the ulna, aligned with the ulnar styloid process. The other arm will be positioned perpendicular to the ground. For both measurements of internal and external rotation, scapular compensation will be monitored by using the thumb on the coracoid process and fingers along the spine of the scapula. Each measurement will be repeated twice with the average measurements used for data analysis.
  • Shoulder ER Strength: Shoulder external rotator strength will be tested with the subject lying supine with the involved shoulder in neutral rotation, 30° shoulder abduction, 90° elbow flexion, and full forearm pronation. The tester will hold a handheld dynamometer perpendicular to the dorsal side of the distal forearm just above the ulnar styloid process (MicroFET®2, Hoggan Scientific LLC, UT). The participant will be asked to hold that position while the tester pushes hard and attempts to break the participant's resistance. The peak force will be read directly from the handheld dynamometer. The shoulder external rotator strength will be tested twice with a minimum of a minute rest between the 2 trials. The average of the 2 trials will be used for data analysis.
  • Blood flow assessment: Each participant will remain in the same position for ultrasound imaging. The ultrasound transducer will be placed perpendicular to the infraspinous fossa to visualize arterioles or arteries of the suprascapular artery as it exits below the spine of the scapula approximately 1 inch below the acromion and to quantify the velocity of blood flow near the tender points of the infraspinatus determined by palpation during the eligibility screen. The location of the transducer will be outlined after initial placement to ensure consistent placement of the transducer between the testing sessions. The spectral Doppler waveforms will be analyzed to trace the velocities throughout the cardiac cycle. The peak systolic (PSV), end diastolic velocity (EDV), resistive index (RI) and pulsatile index (PI) will be calculated using software available on the device. On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window, whereas the EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV and the PI with the formula PI = (PSV - EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle. Three images will be taken, with the average used for data analysis.
  1. Dry Needling Intervention Following the baseline testing, the PI (JB) or Co-PI (SWP) will perform the dry needling intervention. All three have more than 10 years of experience with dry needling. A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the multifidus of C5-C6 on each side of the segment. Once the needle has been inserted, the needle will be pistoned in an up-and-down motion within the multifidus muscle at approximately 1Hz for 10 seconds. The needles will then be left in-situ for 5 minutes. Cadaveric and Ultrasonographic Validation of Needling Placement in the Cervical Multifidus Muscle - ScienceDirect
  2. Post-intervention assessment

The 4 outcome measures will be assessed in the following order to minimize position changes: (1) blood flow parameters in the prone, (2) shoulder range of motions, (3) the number of tender points in the prone position, and then (4) Shoulder ER strength in the supine position. Shoulder ER strength will be assessed 3 times: Immediately, 15 minutes, and 30 minutes after the intervention.

Being tested
Dry Needling
Keywords
neck pain, shoulder pain, muscle pain, dry needling, neck tightness, shoulder tightness
Medical subject headings
Shoulder Pain, Neck Pain, Myalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry NeedlingOther

    A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the multifidus of the C5-C6 cervical muscles. Once the needle has been inserted, the needle will be pistoned in an up and down motion within the multifidus muscle at approximately 1Hz for 10 seconds and then left in-situ for 5 minutes.

Study groups in NCT06705634
Study groupRoleWhat they receive
Experimental: Individuals with neck-shoulder painExperimentalIndividuals with neck-shoulder pain will receive dry needling to C5-C6 multifidus of the cervical spine.
Receives: Other: Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Systolic Velocity

    On a Doppler waveform, the Peak Systolic Velocity corresponds to each "peak" within the spectral window.

    Measured: Change from baseline immediately following the intervention

  2. End Diastolic Velocity (EDV)

    End Diastolic Velocity (EDV) EDV corresponds to the point marked at the end of the cardiac cycle just prior to the systolic peak.

    Measured: Change from baseline immediately following the intervention

  3. Resistive Index (RI)

    Resistive Index is used to assess the resistance in a pulsatile vascular system. The RI is defined by the the formula RI = (PSV - EDV)/PSV.

    Measured: Change from baseline immediately following the intervention

  4. Pulsatile Index (PI)

    Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography. PI is defined with the formula PI = (PSV - EDV)/mean velocity, where mean velocity is the average flow velocity during the cardiac cycle.

    Measured: Change from baseline immediately following the intervention

  5. Shoulder Range of Motion

    Shoulder range of motion of internal and external rotation is the number of degrees of motion measured using standard goniometry.

    Measured: Change from baseline immediately following the intervention

  6. Shoulder External Rotation Strength

    Shoulder external rotation strength will be measured in Newtons using a handheld dynamometer at baseline and post-intervention to assess the effect of dry needling.

    Measured: Change from baseline immediately following the intervention, 15 minutes after the intervention, 30 minutes after the intervention

Secondary outcomes (1)
  1. Number of Tender Points

    The number of tender points will be assessed during palpation of muscle groups innervated by C5-C6, including the cervical paraspinals (C5-6 segment), rhomboids (near the spine of the scapula), supraspinatus muscle belly, middle of the infraspinatus muscle belly, and middle deltoid.

    Measured: Change from baseline immediately following the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start1 Dec 2024
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pre-Test Post-Test Design
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705634
Sponsor's protocol ID
IRB-FY2024-354
Status last verified
Feb 2026
First submitted
19 Nov 2024
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Ceballos-Laita L, Jimenez-Del-Barrio S, Marin-Zurdo J, Moreno-Calvo A, Marin-Bone J, Albarova-Corral MI, Estebanez-de-Miguel E. Effectiveness of Dry Needling Therapy on Pain, Hip Muscle Strength, and Physical Function in Patients With Hip Osteoarthritis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 May;102(5):959-966. doi: 10.1016/j.apmr.2021.01.077. Epub 2021 Feb 7.

    PubMed 33567336

Questions about this trial

What is this clinical trial studying?

A study testing Dry Needling in people with Dry Needling Technique and Neck Pain Musculoskeletal, run by Texas Woman's University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Systolic Velocity (time frame: Change from baseline immediately following the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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