Dry Needling and Exercise for Frozen Shoulder

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Anticoagulants

Disqualifiers: Cervical radiculopathy, Osteoarthritis, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding dry needling (a technique involving the insertion of thin needles into muscles) to exercise benefits people with frozen shoulder, a condition causing pain and stiffness. Participants will be divided into two groups: one will receive real dry needling, while the other will receive a similar-looking placebo treatment. The trial targets individuals who have gradually developed shoulder pain and stiffness, with limited shoulder motion during certain movements. If shoulder pain affects daily activities and has not been recently treated with dry needling, this trial might be suitable. As an unphased trial, it offers a unique opportunity to explore new treatment combinations for frozen shoulder.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently being treated with anticoagulant medication.

What prior data suggests that dry needling is safe for treating frozen shoulder?

Research has shown that dry needling is generally safe for treating shoulder issues such as frozen shoulder. A review of studies found that combining dry needling with physical therapy reduces pain and improves movement. Patients typically tolerate this combination well. One study found that dry needling provided pain relief comparable to a steroid injection, suggesting it as a safe alternative. Some individuals might experience mild discomfort or a small bruise from the needles, but serious side effects are rare. Overall, dry needling appears to be a safe option for improving shoulder movement and reducing pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for frozen shoulder, which often involve physical therapy, anti-inflammatory medications, or corticosteroid injections, dry needling targets muscle knots and trigger points directly. This technique uses thin needles to reach deep muscle tissues, potentially reducing pain and improving mobility more effectively. Researchers are excited about this trial because dry needling, combined with exercise, might offer a faster, more direct approach to relieving symptoms and restoring shoulder function compared to traditional methods.

What evidence suggests that dry needling and exercise could be effective for frozen shoulder?

This trial will compare the effects of dry needling combined with exercise to sham dry needling combined with exercise for treating frozen shoulder. Research has shown that combining dry needling with physiotherapy can reduce pain and improve movement in people with frozen shoulder. Studies have found that dry needling works as well as corticosteroid injections for pain relief. Specifically, one study reported noticeable improvements in shoulder movement, pain levels, and daily activities after just twelve days of treatment. These findings suggest that dry needling could be a promising way to treat frozen shoulder by enhancing shoulder function and easing discomfort. ^{1 2 3 6 7}

Who Is on the Research Team?

Derek Clewley, DPT, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with shoulder pain and stiffness from adhesive capsulitis, also known as frozen shoulder. Participants must have limited shoulder motion, a pain level of at least 2/10 during normal activity, and be able to read and speak English. People with neck-related symptoms, other shoulder conditions, recent needling treatments, fear of needles, on anticoagulants or extreme scores on the Shoulder Pain and Disability Index are excluded.

Inclusion Criteria

I have limited shoulder movement in several directions.

My shoulder movement is limited when I lift my arm sideways.

My symptoms appeared slowly over time.

Exclusion Criteria

Your doctor has found evidence of a different shoulder problem during the examination.

Your shoulder pain and disability index (SPADI) score is too low (less than 10%) or too high (greater than 90%).

My shoulder moves normally without pain or assistance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive either dry needling with exercise or sham dry needling with exercise for shoulder adhesive capsulitis

1 month

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up at 1 week, 1 month, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dry Needling

Trial Overview

The study tests if adding dry needling to exercise therapy improves outcomes in treating frozen shoulder. Participants will be randomly assigned to two groups: one receiving real dry needling at specific trigger points around the affected area; the other getting sham (fake) needle treatment at those same points.

How Is the Trial Designed?

Group I: Dry needling and exercise Experimental Treatment 2 Interventions

Group II: Sham dry needling and exercise Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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This study evaluates the addition of dry needling to exercise as part of physical therapy for the treatment of shoulder adhesive capsulitis.

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The Impact of Dry Needling With Electrical Stimulation on ...

To date, no systematic review and meta-analysis have examined the impact of DNES on outcomes in patients with MSP. This study aims to explore ...