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

NCT06705634 | Active Not Recruiting

• 1 other identifier: IRB-FY2024-354
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dry Needling Technique; Neck Pain Musculoskeletal; Shoulder Pain; Neck Pain; Dry Needling

Keywords

neck pain; shoulder pain; muscle pain; dry needling; neck tightness; shoulder tightness

Outcome Measures

Primary Outcomes (6)

• Peak Systolic Velocity

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

  Change from baseline immediately following the intervention

• 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.

  Change from baseline immediately following the intervention

• 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.

  Change from baseline immediately following the intervention

• 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.

  Change from baseline immediately following the intervention

• Shoulder Range of Motion

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

  Change from baseline immediately following the intervention

• 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.

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

Secondary Outcomes (1)

• Number of Tender Points

  Change from baseline immediately following the intervention

Study Arms (1)

Experimental: Individuals with neck-shoulder pain

EXPERIMENTAL

Individuals with neck-shoulder pain will receive dry needling to C5-C6 multifidus of the cervical spine.

Other: Dry Needling

Interventions

Dry Needling OTHER

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.

Experimental: Individuals with neck-shoulder pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University T. Boone Pickens Institute of Health Sciences

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 33567336 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain; Neck Pain; Myalgia

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

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: Assistant Professor of Physical Therapy

Model Details: Pre-Test Post-Test Design

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When the summary data are published. Data obtained through this study may be provided to qualified researchers with academic interest in Dry Needling. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).

Locations

US (1)