The Effects of Dry Needling on Patients With Knee Pain

NCT02890485 | Recruiting FDA Device

• 1 other identifier: 2016H0003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Anterior Knee Pain Syndrome; Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (2)

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

  The AKPS is commonly used to evaluate function in patients with PFPS. It is a 13-item questionnaire with a maximum score of 100. Higher scores are indicative of better function. The minimal detectable change (MDC) and the minimal clinically important difference (MCID) of the AKPS has been reported to be 10 and 13 points respectively and has high test-retest reliability (ICC: 0.81 to 0.95). The standard error of measurement is 3 and has been shown to be valid (0.92).

  Baseline and Post testing (week 3)

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

  Pain will be measured using the numeric pain rating scale (NPRS). Patients will be asked to rate their pain on 11-point (0-10) scale with 0 being no pain and 10 being extreme pain. The NPRS is a common measure of pain in patients with PFPS and has been shown to be reliable and responsive (minimal clinically important difference = 2 points).

  Baseline and Post testing (week 3)

Secondary Outcomes (4)

• Change from Baseline Lateral step-down (LSD) test score to 3 weeks

  Baseline and Post testing (week 3)

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

  Baseline and Post testing (week 3)

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

  Baseline and Post testing (week 3)

• Change from Baseline Pressure Pain Threshold to 3 weeks

  Baseline and Post testing (week 3)

Study Arms (5)

Glute Dry Needling

EXPERIMENTAL

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

Device: Dry Needling

Quad Dry Needling

EXPERIMENTAL

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

Device: Dry Needling

Glute Sham Dry Needling

SHAM COMPARATOR

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

Device: Sham Dry Needling

Quad Sham Dry Needling

SHAM COMPARATOR

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

Device: Sham Dry Needling

Control

ACTIVE COMPARATOR

Receives only standard physical therapy treatment.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

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.

Also known as: Exercise

Control

Dry Needling DEVICE

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.

Also known as: Trigger Point Acupunture

Glute Dry Needling; Quad Dry Needling

Sham Dry Needling DEVICE

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.

Glute Sham Dry Needling; Quad Sham Dry Needling

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221, United States

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Dry Needling; Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthew S Briggs, DPT, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kat Rethman, DPT

CONTACT

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

Cody Mansfield, DPT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Practice

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 7, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)