Dry Needling and Shoulder Muscle Blood Flow, Motions, and Pain Sensitivity in Individuals with Shoulder Pain

NCT05596240 | Active Not Recruiting

• 1 other identifier: IRB-FY2022-438
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder pain is one of the most common reasons people consult with their primary health care provider, and 40-50% of these patients with shoulder pain continued to complain of persistent symptoms after 6 to 12 months. It has been suggested that the presence of myofascial trigger points (MTrPs) may contribute to the chronicity of shoulder symptoms. An MTrP is a hyperirritable taut band of tissue within a muscle that produces pain when stimulated MTrPs are common in patients with shoulder disorders and occur most often in the infraspinatus muscle of a painful shoulder MTrPs were associated with an acidic biochemical environment with elevated levels of inflammatory mediators, neuropeptides, and proinflammatory cytokines such as bradykinin and calcitonin g-related peptide. It was hypothesized that metabolic demands on muscle and capillary constrictions may contribute to the development of MTrPs. To date, only a few studies have examined the vascular environment of MTrPs and surrounding areas before and after dry needling. No studies have yet examined whether dry needling would change blood flow in patients with shoulder pathology. Therefore, the purpose of this pilot study is to examine the effect of dry needling on blood flow of the infraspinatus muscle using color Doppler imaging in individuals with shoulder pain. The secondary purpose is to examine the effect of DN on shoulder motion and sensitivity to pressure in individuals with shoulder pain.

Conditions

Dry Needling; Shoulder Pain

Keywords

dry needling; shoulder pain; pain pressure threshold

Outcome Measures

Primary Outcomes (4)

• Peak Systolic Velocity

  On a Doppler waveform, the PSV corresponds to each "peak" within the spectral window. These values will be used to calculate the RI with the formula RI = (PSV - EDV)/PSV.

  Change from baseline PSV immediately

• 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 RI immediately

• 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 PI immediately

• 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 EDV immediately

Secondary Outcomes (2)

• Pain Pressure Thresholds (PPT)

  Change from baseline PPT immediately

• Shoulder Range of Motion

  Change from baseline shoulder range of motion immediately

Study Arms (2)

Dry Needling

EXPERIMENTAL

Individuals with shoulder pain will receive dry needling to the two to four most tender points in the infraspinatus based on examiner palpation

Other: Dry Needling

Sham Dry Needling

PLACEBO COMPARATOR

Individuals with shoulder pain will receive sham dry needling to two points in the muscle belly of the infraspinatus near the insertion and below the midpoint of the spine of the scapula

Other: Sham Dry Needling

Interventions

Dry Needling OTHER

A sterile, disposable, solid filament needle (Seirin Corp., Shizuoka, Japan) will be inserted manually into the MTrP of the infraspinatus muscles. Once the needle has been inserted, the technique described by Hong (1994) will be used. The needle will be pistoned in an up and down motion within the infraspinatus muscle at approximately 1Hz for 10 seconds with the aim of eliciting local twitch responses.

Dry Needling

Sham Dry Needling OTHER

Streitberger Placebo-needles (Asia-med, Las Vegas, NV) will be used to perform the intervention for participants in the sham DN group. These needles have been reported to be indistinguishable from real needles. The device consists of a plastic tube with a blunted tip needle that allows for the sensation of a prick without penetrating the skin. The sham needle produces a sensation, which causes the participant to feel as if the needle enters the skin, while maintaining similar patient-therapist contact time and total intervention time.

Sham Dry Needling

Eligibility Criteria

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

You may qualify if:

• Ages 18-65 with unilateral nonspecific shoulder pain based on participants' self-reported pain level of greater than or equal to 2/10 on the Numeric Pain Rating Scale (NPRS) in last 24 hours
• non-traumatic origin of pain
• presence of at least one MTrP with referral pain pattern in the infraspinatus muscle determined through palpation.

You may not qualify if:

• systemic joint disease (e.g. rheumatoid arthritis)
• evidence of red flags (e.g. signs of current fracture or history of fracture to scapula, glenoid or proximal humerus, infection, tumor, incontinence, or paresthesias)
• cancer
• neurological disorders
• neuropathy
• Raynaud's disease
• pregnancy
• previous shoulder surgery
• repeated infection (e.g. systemic infection, red skin, fever, individuals who are visibly unwell or toxic in appearance)
• immunocompromised disease (e.g., diabetes mellitus, HIV, AIDS, lupus)
• inability to maintain the testing and treatment positions (i.e., supine and prone-lying) for 15 minutes at a time.
• bleeding disorders (e.g. hemophilia)
• use of anti-coagulants (e.g. vitamin K antagonists, direct oral anticoagulants, and low molecular weight heparins)

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

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

Dallas, Texas, 75235, United States

Location

Related Publications (9)

• Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.

  PMID: 21711512 BACKGROUND

• Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.

  PMID: 15163107 BACKGROUND

• Hidalgo-Lozano A, Fernandez-de-las-Penas C, Diaz-Rodriguez L, Gonzalez-Iglesias J, Palacios-Cena D, Arroyo-Morales M. Changes in pain and pressure pain sensitivity after manual treatment of active trigger points in patients with unilateral shoulder impingement: a case series. J Bodyw Mov Ther. 2011 Oct;15(4):399-404. doi: 10.1016/j.jbmt.2010.12.003. Epub 2011 Jan 17.

  PMID: 21943613 BACKGROUND

• Ge HY, Fernandez-de-Las-Penas C, Yue SW. Myofascial trigger points: spontaneous electrical activity and its consequences for pain induction and propagation. Chin Med. 2011 Mar 25;6:13. doi: 10.1186/1749-8546-6-13.

  PMID: 21439050 BACKGROUND

• Shah JP, Thaker N, Heimur J, Aredo JV, Sikdar S, Gerber L. Myofascial Trigger Points Then and Now: A Historical and Scientific Perspective. PM R. 2015 Jul;7(7):746-761. doi: 10.1016/j.pmrj.2015.01.024. Epub 2015 Feb 24.

  PMID: 25724849 BACKGROUND

• Sandberg M, Lundeberg T, Lindberg LG, Gerdle B. Effects of acupuncture on skin and muscle blood flow in healthy subjects. Eur J Appl Physiol. 2003 Sep;90(1-2):114-9. doi: 10.1007/s00421-003-0825-3. Epub 2003 Jun 24.

  PMID: 12827364 BACKGROUND

• 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.

  PMID: 8043247 BACKGROUND

• Park G, Kim CW, Park SB, Kim MJ, Jang SH. Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. Ann Rehabil Med. 2011 Jun;35(3):412-7. doi: 10.5535/arm.2011.35.3.412. Epub 2011 Jun 30.

  PMID: 22506152 BACKGROUND

• Nascimento JDSD, Alburquerque-Sendin F, Vigolvino LP, Oliveira WF, Sousa CO. Absolute and Relative Reliability of Pressure Pain Threshold Assessments in the Shoulder Muscles of Participants With and Without Unilateral Subacromial Impingement Syndrome. J Manipulative Physiol Ther. 2020 Jan;43(1):57-67. doi: 10.1016/j.jmpt.2019.04.002. Epub 2020 Feb 13.

  PMID: 32061418 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Jace A Brown, DPT

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant will not be told whether they are assigned to the interventional or sham group. The outcomes (blood flow, pain pressure threshold, and range of motion) will be assessed by an investigator blinded to the intervention assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pre-test Post-Test Design

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 27, 2022
• Study Start: October 22, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

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)