Bilateral Knee Pain and Dry Needling

NCT05976269 | Active Not Recruiting FDA Device

• 1 other identifier: 2020H0332
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project will evaluate the effects of bilateral knee pain and dry needling (DN) on laterality recognition, movement and muscle function. The objective is to determine if laterality recognition accuracy deficits are present in individuals with bilateral chronic knee pain and if DN affects 'central' and 'peripheral' musculoskeletal measurements. Chronic musculoskeletal pain results in changes to the way the brain perceives pain and left-right discrimination between body parts. This phenomenon has been established for individuals with chronic back pain and chronic regional pain syndrome, but has not been described for individuals with bilateral knee pain without the presence of knee OA. Dry needling involves the insertion of a small diameter monofilament needle into muscle, and has been purported to affect the neuromuscular system both centrally and peripherally. Sixty individuals between 18 and 40 years old will be recruited and allocated into three groups. The first group will consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37. The second group with consist of 20 subjects with bilateral chronic anterior knee pain and low fear of movement between ages of 18 and 40 years old, and the third group will consist of healthy controls without knee pain between 18 and 40 years old. All subjects will undergo baseline testing consisting of laterality recognition, movement analysis, muscle force production, and ultrasound imaging. Subjects will undergo laterality recognition testing using the Neuro Orthopaedic Institute (NOI) Recognise Knee phone application. 2D video analysis of the lateral step down test will be performed followed by peak isometric force production assessment of knee extension and flexion. Muscle function of the vastus medialis will be measured with ultrasound imaging where cross-sectional area and other measurements (tendon length, muscle thickness, etc) will be captured with Lumify ultrasound imaging transducer. Then DN to the quadriceps will be performed. After DN procedure, subjects will undergo aforementioned measurements from baseline testing. Testing will require only one appointment by the subject, which will last approximately 2 hours an include baseline testing, dry needling, and post testing. No follow up will occur afterwards.

Conditions

Patellofemoral Pain

Keywords

Knee; Dry needling; Acupuncture; Implicit Motor Imagery; Graded Motor Imagery

Outcome Measures

Primary Outcomes (1)

• Accuracy and response time from left right judgement task

  This is referred to as implicit motor imagery performance and participants have to accurately identify if a group of randomized knee images is a left or a right.

  Complete immediately before, and immediately after dry needling procedure.

Secondary Outcomes (2)

• 2D Video Assessment of Movement Patterns During Lateral step down test.

  Complete immediately before, and immediately after dry needling procedure.

• Muscle depth of of vastus medialis oblique muscle as measured by Lumify US unit

  Complete immediately before and immediately after dry needling procedure.

Study Arms (3)

Bilateral Patellofemoral Pain with Fear of Movement

EXPERIMENTAL

The first group will consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37.

Device: Dry needling

Bilateral Patellofemoral Pain with Low Fear of Movement

EXPERIMENTAL

The second group with consist of 20 subjects with bilateral chronic anterior knee pain and low fear of movement between ages of 18 and 40 years old.

Device: Dry needling

Healthy controls without knee pain

ACTIVE COMPARATOR

The third group will consist of healthy controls without knee pain between 18 and 40 years old.

Device: Dry needling

Interventions

Dry needling DEVICE

Dry needling will be performed by licensed physical therapists who are formally trained in dry needling and meet all of the requirements of the state of Ohio and agree to participate as key personnel in this study. These therapists will receive specialized training in the study protocol including appropriate documentation, standardized dry needling technique/procedures, and study communication. Dry needling will be performed in a clean field using sterile acupuncture needles of appropriate length to pierce muscle bellies based on patient size and muscle mass.

Bilateral Patellofemoral Pain with Fear of Movement; Bilateral Patellofemoral Pain with Low Fear of Movement; Healthy controls without knee pain

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For high fear group: Age between 18 and 40 years old, pain greater than or equal to 3 months, Tampa scale of kinesiophobia \>37, anterior knee pain scale \<90, and no evidence of knee OA
• For low fear group: Age between 18 and 40 years old, pain greater than or equal to 3 months, Tampa scale of kinesiophobia \<37, anterior knee pain scale \<90, and no evidence of knee OA
• For control group: no surgery in past 6 months, age between 18 and 40 years old, no knee OA, Tampa Scale \<10, and anterior knee pains scale \>90

You may not qualify if:

• Knee surgery in past 6 months, previous dry needling or acupuncture to knee, pregnancy, menicscal/cartilage/ligamentous injury, history of patellar subluxations, dislocations, or MPFL reconstruction, contraindications to dry needling or acupuncture, or neurological condition that affects movement.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center, Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Matthew S Briggs, DPT, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Practice

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: July 21, 2020
• Primary Completion (Estimated): July 21, 2028
• Study Completion (Estimated): July 21, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)