Dry Needling for Shoulder Pain

Overseen By Sharon Wang-Price, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Woman's University

Must not be taking: Anti-coagulants

Disqualifiers: Systemic joint disease, Cancer, Neurological disorders, Pregnancy, Others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using anti-coagulants (medications that prevent blood clotting).

What data supports the effectiveness of the treatment Dry Needling for Shoulder Pain?

Research shows that dry needling can help reduce pain and improve movement in people with shoulder pain, especially when used alongside other treatments like physical therapy. However, one study found that dry needling did not provide extra benefits when added to personalized physical therapy for nonspecific shoulder pain. ^{1 2 3 4 5}

Is dry needling safe for humans?

Dry needling is generally well tolerated, but mild adverse events can occur, and there are rare reports of severe complications like spinal epidural hematoma. It's important for practitioners to screen patients carefully and take precautions, especially when needling near sensitive areas like the spine. ^{6 7 8 9 10}

How does the treatment dry needling differ from other treatments for shoulder pain?

Dry needling is unique because it targets myofascial trigger points (tight knots in muscles) to relieve pain, which is different from other treatments that may not focus on these specific muscle areas. It involves inserting thin needles into the skin and muscle, which is a different approach compared to physical therapy or medication. ^{2 3 11 12 13}

What is the purpose of this trial?

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.

Research Team

Jace A Brown, DPT

Principal Investigator

Texas Woman's University

Eligibility Criteria

This trial is for individuals aged 18-65 with unilateral shoulder pain of non-traumatic origin, a self-reported pain level of at least 2/10, and at least one myofascial trigger point in the infraspinatus muscle. It excludes those with systemic joint diseases, red flags like fractures or tumors, cancer, pregnancy, anti-coagulant use, previous shoulder surgery, immunocompromised conditions (like diabetes), repeated infections or neurological disorders.

Inclusion Criteria

I am between 18 and 65 years old and have shoulder pain rated at least 2/10.

My pain is not due to an injury.

I have a painful spot in my shoulder muscle that hurts when pressed.

Exclusion Criteria

I frequently get infections, including fevers and red skin.

I have had shoulder surgery before.

I am currently taking blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo baseline assessments including demographic information, pain characteristics, and initial outcome measures such as blood flow parameters, shoulder ROMs, and PPTs.

1 visit

1 visit (in-person)

Intervention

Participants receive either real dry needling or sham dry needling to the infraspinatus muscle.

1 session

1 visit (in-person)

Immediate Post-Intervention Assessment

Outcome measures are reassessed immediately following the intervention to capture immediate changes.

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for any adverse events and changes in outcome measures post-intervention.

2-4 weeks

Treatment Details

Interventions

• Dry Needling
• Sham Dry Needling

Trial Overview The study tests whether dry needling can improve blood flow in the infraspinatus muscle using color Doppler imaging. Participants will also be assessed for changes in shoulder motion and pressure sensitivity post-treatment compared to sham dry needling.

Participant Groups

Group I: Dry Needling Experimental Treatment 1 Intervention

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

Group II: Sham Dry Needling Placebo Group 1 Intervention

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

Dry Needling is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Dry Needling for:

• Knee osteoarthritis pain management
• Muscle strength improvement
• Leg function enhancement

Approved in United States as Dry Needling for:

• Chronic knee pain relief
• Musculoskeletal pain management
• Myofascial pain syndrome treatment

Who Is Running the Clinical Trial?

Texas Woman's University

Lead Sponsor

Trials

90

Recruited

5,900+

Findings from Research

A study involving 39 patients with shoulder impingement syndrome showed that both dry needling (DN) and muscle energy technique (MET) effectively reduced pain and improved shoulder range of motion (ROM) over three treatment sessions.

While all treatment groups experienced significant improvements, dry needling was particularly more effective in enhancing shoulder flexion and abduction compared to MET alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dry needling & muscle energy technique separately and in combination in patients suffering shoulder impingement syndrome and active trigger points of infraspinatus. Jalilipanah, P., Okhovatian, F., Serri, RA., et al.[2021]

In a study involving 120 patients with nonspecific shoulder pain, the addition of dry needling to personalized physical therapy did not show any significant benefits compared to physical therapy alone.

Both treatment groups experienced improvements over time, indicating that personalized physical therapy is effective on its own for managing shoulder pain, while dry needling did not enhance these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial. Pérez-Palomares, S., Oliván-Blázquez, B., Pérez-Palomares, A., et al.[2022]

Dry needling of myofascial trigger points (MTrPs) is effective for reducing neck and shoulder pain in the short term (up to 3 days) and medium term (up to 28 days), based on a meta-analysis of 20 randomized controlled trials involving 839 patients.

However, wet needling (which includes the use of lidocaine) was found to be more effective than dry needling for relieving MTrP pain in the medium term, suggesting that while dry needling is beneficial, other treatments may provide better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. Liu, L., Huang, QM., Liu, QG., et al.[2022]

In a randomized controlled trial involving 88 patients with shoulder adhesive capsulitis, intramuscular electrical stimulation (IMES) combined with therapeutic exercises showed significantly greater improvements in shoulder pain severity, disability, and range of motion compared to dry needling (DN) combined with therapeutic exercises.

Both treatment groups experienced significant improvements in pain and function, but IMES did not reach the minimal clinically important differences for pain and disability scores, indicating that while effective, further improvements may be needed for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intramuscular Electrical Stimulation Combined with Therapeutic Exercises in Patients with Shoulder Adhesive Capsulitis: A Randomised Controlled Trial. Shanmugam, S., Mathias, L., Manickaraj, N., et al.[2022]

Moderate-quality evidence indicates that trigger point (TrP) dry needling can reduce shoulder pain intensity with a small effect, based on a meta-analysis of 6 randomized clinical trials involving various participants.

There is low-quality evidence suggesting that TrP dry needling significantly improves pain-related disability, showing a large effect, although these benefits are primarily observed in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Trigger Point Dry Needling for Nontraumatic Shoulder Pain of Musculoskeletal Origin: A Systematic Review and Meta-Analysis. Navarro-Santana, MJ., Gómez-Chiguano, GF., Cleland, JA., et al.[2021]

In a study involving 39 physiotherapists and 7629 treatments, trigger point dry needling (TrP-DN) was found to have a high incidence of mild adverse events (AEs), with 1463 reported cases, but no significant AEs occurred, indicating a very low risk of serious complications (≤ 0.04%).

Common mild AEs included bruising (7.55%) and bleeding (4.65%), but the overall safety profile suggests that TrP-DN is a safe treatment option for myofascial pain when performed by trained physiotherapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. Brady, S., McEvoy, J., Dommerholt, J., et al.[2022]

In a study involving 40 overhead athletes, combining dry needling (DN) with manual therapy (MT) significantly reduced pain and disability while improving scapular dyskinesia compared to MT alone.

The treatment group experienced substantial improvements in pain and function (P < 0.05), while no adverse effects were reported, highlighting DN as a safe and effective method for treating shoulder dysfunctions in athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between dry needling plus manual therapy with manual therapy alone on pain and function in overhead athletes with scapular dyskinesia: A randomized clinical trial. Kheradmandi, A., Kamali, F., Ebrahimian, M., et al.[2021]

Myofascial trigger points are linked to various systemic and psychological factors, making it essential for clinicians to thoroughly screen patients for underlying conditions before using dry needling as a treatment.

Clinicians should be aware of specific medical conditions and comorbidities that could affect the safety and efficacy of dry needling, including those that may present with similar symptoms to musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New perspectives on dry needling following a medical model: are we screening our patients sufficiently? Kearns, G., Fernández-De-Las-Peñas, C., Brismée, JM., et al.[2020]

This study will evaluate the effectiveness of combining dry needling with manual physiotherapy and therapeutic exercise for treating chronic shoulder pain in 36 participants over 6 weeks, with a follow-up period of 6 months.

The main outcome measure will be pain reduction assessed using the Visual Analogue Scale, aiming to provide new insights into the treatment of chronic shoulder pain associated with myofascial trigger points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial. Tejera-Falcón, E., Toledo-Martel, NDC., Sosa-Medina, FM., et al.[2018]

Dry needling is generally safe and well tolerated for treating myofascial pain, but there is a risk of severe complications, such as an acute spinal epidural hematoma, as highlighted in this case report.

Healthcare providers should exercise caution when performing dry needling near the spine, and any sudden neuropathic pain following the procedure should be evaluated immediately with advanced imaging to ensure spinal cord integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. Berrigan, WA., Whitehair, CL., Zorowitz, RD.[2020]

A study involving 57 volunteers with unilateral subacromial pain syndrome showed that dry needling the infraspinatus muscle significantly improved pain sensitivity and shoulder range of motion (ROM) in the affected shoulder, with benefits observed 3-4 days post-treatment.

While participants reported increased pressure pain thresholds and improved internal rotation and horizontal adduction ROM, there were no significant changes in muscle thickness, indicating that dry needling may primarily affect pain and mobility rather than muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dry needling to the symptomatic versus control shoulder in patients with unilateral subacromial pain syndrome. Koppenhaver, S., Embry, R., Ciccarello, J., et al.[2022]

A single session of dry needling targeting both a latent and an active myofascial trigger point in the infraspinatus muscle significantly reduced pain intensity and increased pressure pain threshold in older adults with nonspecific shoulder pain.

The treatment showed benefits immediately and one week post-intervention, but did not result in significant improvements in grip strength, indicating its primary efficacy in pain management rather than functional strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry Needling on the Infraspinatus Latent and Active Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain: A Randomized Clinical Trial. Calvo-Lobo, C., Pacheco-da-Costa, S., Martínez-Martínez, J., et al.[2022]

Dry needling of scapulohumeral muscles in four international female volleyball athletes resulted in significant short-term improvements in range of motion, strength, and pain relief during a month of intense competition.

The treatment allowed athletes to continue overhead activities without pain, suggesting that dry needling can effectively support shoulder injury management in elite athletes during competitive phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of shoulder injuries using dry needling in elite volleyball players. Osborne, NJ., Gatt, IT.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of dry needling & muscle energy technique separately and in combination in patients suffering shoulder impingement syndrome and active trigger points of infraspinatus. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of dry needling for myofascial trigger points associated with neck and shoulder pain: a systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intramuscular Electrical Stimulation Combined with Therapeutic Exercises in Patients with Shoulder Adhesive Capsulitis: A Randomised Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Trigger Point Dry Needling for Nontraumatic Shoulder Pain of Musculoskeletal Origin: A Systematic Review and Meta-Analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison between dry needling plus manual therapy with manual therapy alone on pain and function in overhead athletes with scapular dyskinesia: A randomized clinical trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

New perspectives on dry needling following a medical model: are we screening our patients sufficiently? [2020]

9. England pubmed.ncbi.nlm.nih.gov

Dry needling in a manual physiotherapy and therapeutic exercise protocol for patients with chronic mechanical shoulder pain of unspecific origin: a protocol for a randomized control trial. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. [2020]

11. Scotland pubmed.ncbi.nlm.nih.gov

Effects of dry needling to the symptomatic versus control shoulder in patients with unilateral subacromial pain syndrome. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Dry Needling on the Infraspinatus Latent and Active Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain: A Randomized Clinical Trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Management of shoulder injuries using dry needling in elite volleyball players. [2022]