What side effects are associated with this type of intervention?

Common treatments for Patellofemoral Pain Syndrome (PFPS) that focus on muscle relaxation and pain relief include physical therapy, acupuncture, and dry needling. Physical therapy is generally safe but may cause temporary muscle soreness or fatigue. Acupuncture and dry needling can lead to minor side effects such as bruising, bleeding, or soreness at the needle insertion sites. Serious complications are rare but can include infections or injury to underlying tissues. Overall, these treatments are considered low-risk and effective for managing PFPS symptoms.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for Patellofemoral Pain Syndrome (PFPS). However, general pain management strategies for similar conditions include the use of nonsteroidal anti-inflammatory drugs (NSAIDs), physical therapy, and techniques like dry needling. Dry needling, which involves inserting small needles into muscle tissue to relieve pain and improve function, is being studied for its effectiveness in managing knee pain, including PFPS. While dry needling itself may not have specific FDA approval for PFPS, it is a recognized technique in pain management.

What other types of research exist?

Promising novel alternatives to dry needling for Patellofemoral Pain Syndrome patients include: 1) Platelet-Rich Plasma (PRP) injections, which have shown effectiveness in reducing pain and improving function in knee osteoarthritis and may be beneficial for PFPS. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which has been effective in managing chronic pain conditions. 3) Ultrasound-Guided Genicular Nerve Blockade, which provides targeted pain relief. 4) High-Intensity Strength Training, which can improve muscle strength and reduce pain. 5) Low-Level Laser Therapy (LLLT), which has shown promise in reducing pain and improving function in chronic pain conditions.

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Dry Needling for Knee Pain

N/A

Recruiting

Led By Matthew S Briggs, DPT, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

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

Must have

18-40 years-of-age

Presence of anterior knee pain around the patella during ascending/descending stairs, squatting, and/or running for at least 3 months.

Must not have

Received previous dry needling treatments

History of pain less than 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post testing (week 3)

Summary

This trial is testing dry needling for knee pain relief in patients with patellofemoral pain syndrome. The treatment involves inserting small needles into muscles to help them relax and reduce pain. The study aims to see if this method improves pain, muscle strength, and leg function.

Who is the study for?

This trial is for individuals aged 18-40 with knee pain around the patella when doing activities like stairs, squatting, or running for at least 3 months. They must be referred for physical therapy and not currently receiving other treatments for knee pain. People can't join if they have bilateral knee syndrome, recent surgery or PT treatment, pregnancy, neurological conditions affecting movement, needle phobias, bleeding disorders, cancer diagnosis or systemic illnesses.

What is being tested?

The study examines dry needling's effectiveness in managing knee pain and improving muscle strength and leg function. Participants will receive either actual dry needling or a sham (fake) procedure alongside their regular physical therapy to compare outcomes.

What are the potential side effects?

Dry needling may cause some discomfort at the needle site, minor bleeding or bruising. Rarely it might lead to fatigue or dizziness immediately after treatment. Serious side effects are uncommon but could include infection at the puncture site.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 40 years old.

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I have had knee pain near my kneecap when moving or squatting for over 3 months.

Exclusion Criteria

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

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I have had dry needling treatments before.

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I have been experiencing pain for less than 3 months.

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I do not have bleeding disorders, needle phobia, active cancer, or any illness like fever or infection.

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I have had surgery to fix my kneecap alignment.

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I have pain in the front of both knees.

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I have a condition that affects my ability to move.

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I am unable to give my consent.

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My kneecap frequently dislocates or feels unstable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post testing (week 3)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post testing (week 3)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post testing (week 3) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks

Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks

Secondary study objectives

Change from Baseline Isometric knee and hip peak torque values to 3 weeks

Lysergic Acid Diethylamide

Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks

+1 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Quad Dry NeedlingExperimental Treatment1 Intervention

Receives dry needling to their quadriceps muscles in addition to standard physical therapy treatment.

Group II: Glute Dry NeedlingExperimental Treatment1 Intervention

Receives dry needling to their gluteal muscles in addition to standard physical therapy treatment.

Group III: ControlActive Control1 Intervention

Receives only standard physical therapy treatment.

Group IV: Glute Sham Dry NeedlingPlacebo Group1 Intervention

Receives sham dry needling to their gluteal muscles in addition to standard physical therapy treatment.

Group V: Quad Sham Dry NeedlingPlacebo Group1 Intervention

Receives sham dry needling to their quadriceps muscles in addition to standard physical therapy treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dry Needling

2020

Completed Phase 2

~1090

0 / 10Eligibility 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

Common treatments for Patellofemoral Pain Syndrome (PFPS) often focus on muscle relaxation and pain relief, similar to the mechanisms of dry needling. Dry needling involves inserting small needles into muscle tissue to release tension and reduce pain by promoting muscle relaxation and improving blood flow. This is crucial for PFPS patients as it helps alleviate the pain and discomfort associated with muscle tightness and imbalances around the knee joint. Other treatments, such as physical therapy exercises, aim to strengthen and stretch the muscles around the knee, improving alignment and reducing stress on the patellofemoral joint. These approaches collectively help in managing pain and enhancing knee function, which is essential for the daily activities and overall quality of life of PFPS patients.

Patellar taping for patellofemoral pain syndrome in adults.