What side effects are associated with this type of intervention?

Common treatments for Frozen Shoulder include physical therapy, corticosteroid injections, and dry needling. Dry needling, which involves inserting needles into muscle trigger points, can cause side effects such as temporary pain at the needle site, bleeding, bruising, and, in rare cases, infection. Corticosteroid injections may lead to side effects like pain at the injection site, facial flushing, and elevated blood sugar levels. Physical therapy, while generally safe, can sometimes result in temporary pain or discomfort during or after exercises.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned for the treatment of Frozen Shoulder using dry needling or similar techniques. However, dry needling itself is a technique used in physical therapy to release muscle tension, reduce pain, and improve range of motion by inserting needles into muscle trigger points. Other treatments for Frozen Shoulder typically include physical therapy, corticosteroid injections, and sometimes surgical interventions.

What other types of research exist?

Promising novel alternatives to dry needling for frozen shoulder patients include: <ol> <li>Platelet-Rich Plasma (PRP) Therapy: PRP involves injecting concentrated platelets from the patient's own blood to promote healing and reduce inflammation.</li> <li></li> </ol> Mesenchymal Stem Cell (MSC) Therapy: MSCs can potentially regenerate damaged tissues and reduce inflammation, although they are still largely investigational. 3. Extracorporeal Shockwave Therapy (ESWT): This non-invasive treatment uses acoustic waves to promote healing and reduce pain. 4. Acupuncture: While more research is needed, some studies suggest it may provide short-term pain relief and improve function. 5. Corticosteroid Injections: These can provide immediate pain relief and reduce inflammation, although they are not novel, they remain a highly effective option.

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Dry Needling and Exercise for Frozen Shoulder

N/A

Waitlist Available

Led By Derek Clewley, DPT, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Glenohumeral passive range of motion limited in multiple directions

Age 18 to 65 years

Must not have

Normal passive shoulder range of motion

Signs or symptoms of cervical radiculopathy, radiculitis, or referral from the cervical spine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-week, 1-month, 6-months

Summary

This trial tests if adding dry needling to exercise helps people with shoulder adhesive capsulitis more than exercise alone. Dry needling uses thin needles to relax tight muscles and reduce pain. Dry needling is recommended to relieve myofascial trigger point pain in the short term.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dry needling can cause side effects like temporary soreness or bruising where the needles are inserted. Some people might feel faint or experience an aggravation of symptoms initially after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have limited shoulder movement in several directions.

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I am between 18 and 65 years old.

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My pain level during normal activities is 2 or more out of 10.

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I am experiencing shoulder pain and stiffness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My shoulder moves normally without pain or assistance.

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I have pain or symptoms that suggest a nerve issue in my neck.

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I have shoulder arthritis confirmed by an X-ray.

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I am currently on blood thinner medication.

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I have a diagnosed neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-week, 1-month, 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-week, 1-month, 6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-week, 1-month, 6-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Shoulder Pain and Disability Index Change

Secondary study objectives

Numeric Pain Rating Scale Change

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Dry needling and exerciseExperimental Treatment2 Interventions

Group II: Sham dry needling and exercisePlacebo Group2 Interventions

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dry needling, a common treatment for Frozen Shoulder, involves inserting needles into muscle trigger points to release tension, reduce pain, and improve range of motion. This technique is particularly beneficial for Frozen Shoulder patients as it directly addresses muscle tightness and pain, which are primary symptoms of the condition. Other treatments, such as physical therapy, focus on stretching and strengthening exercises to enhance mobility, while corticosteroid injections aim to reduce inflammation and pain. These treatments collectively help in restoring shoulder function and alleviating discomfort.

Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration.