Recruiting

Dry Needling

Sponsor:

Ohio State University

Code:

NCT02890485

Conditions

Patellofemoral Pain Syndrome

Anterior Knee Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Dry Needling

Sham Dry Needling

Physical Therapy

Study Details

Brief summary:

This study is testing the effectiveness of "dry needling" for pain management and on muscle strength and leg function for those with knee pain. Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function.

Conditions

Patellofemoral Pain Syndrome

Anterior Knee Pain Syndrome

Study ID

NCT02890485

Start date

Aug, 2016

Status verified date

Feb, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-40 years-of-age
  • Referred for physical therapy
  • Presence of anterior knee pain around the patella during ascending/descending stairs, squatting, and/or running for at least 3 months.

Exclusion Criteria:

  • Unable to provide consent
  • Bilateral patellofemoral pain syndrome
  • Received previous dry needling treatments
  • Pregnancy
  • History of pain less than 3 months
  • Imaging demonstrating the presence of confounding internal abnormality (e.g. chondral defects, ligamentous injury, and/or meniscal pathology),
  • Patellar instability
  • Presence of a neurological condition that would affect movement
  • Contraindications to dry needling techniques (e.g. a history of bleeding disorders, phobia of needles, an active cancer diagnosis, and presence of other systemic illness such as fever or signs of infection)
  • Actively receiving treatment for knee pain outside of the current study protocol while enrolled in the study;
  • received active and supervised PT treatment for knee pain within the last 4 weeks;
  • history of knee surgery less than 6 months ago
  • history of surgical correction of the patellofemoral complex (e.g. MPFL reconstruction, patellar realignment surgery, etc)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glute Dry Needling

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

experimental: Quad Dry Needling

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

sham comparator: Glute Sham Dry Needling

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

sham comparator: Quad Sham Dry Needling

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

active comparator: Control

Receives only standard physical therapy treatment.

Interventions

Dry Needling

Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function. Dry needling will be performed in the gluteal or the quadriceps muscle groups depending upon group randomization.

Sham Dry Needling

The same overall procedures will be used as in the "true" dry needling groups and applied to the same muscle groups (gluteal or quadriceps) depending upon ground randomization. Sham dry needling will be performed using a commercially available sham needling system commonly.This set-up utilizes a blunt tipped needle. When the sham needle is pressed downward, the barrel of the needle retracts into the handle, giving the appearance of insertion of the needle through the skin. This also creates pressure on the subject's skin, increasing the sensation of dry needling. Patients will not be allowed to observe the areas being needled or sham needled.

Physical Therapy

Physical Therapy and exercise as determined by the examining clinician based on the patients specific impairments and functional limitations. All subjects enrolled in this study will receive an initial physical therapy (PT) evaluation and then 2 additional PT sessions a week a part. Interventions and prescribed home exercises will be specific to the patients' primary individual impairments as determined during the initial PT evaluation. These interventions reflect current evidence, but will not be restrictive to specific exercises; prescribed exercises will be deemed appropriate based on the treating PTs' examination, evaluation, and identification of each patients' primary deficits, impairments, functional limitations, and current literature.

Primary outcome measure

  • Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks [ Time Frame: Baseline and Post testing (week 3) ]
  • Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks [ Time Frame: Baseline and Post testing (week 3) ]

Central Contacts and Locations

Central contacts

Kat Rethman, DPT

614-293-2385katherine.rethman@osumc.edu

Cody Mansfield, DPT

714-609-1904cody.mansfield@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Erik Hemenway, PTA

614-293-2385Erik.Hemenway@osumc.edu

John DeWitt, DPT

614-293-2385John.DeWitt@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-25.