Patellofemoral Pain SyndromeNCT02890485
The Effects of Dry Needling on Patients With Knee Pain
A study testing Dry Needling and Physical Therapy in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
- What is being tested?
- Dry Needling and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
Erik Hemenway, PTA, 614-293-2385, Erik.Hemenway@osumc.edu
John DeWitt, DPT, 614-293-2385, John.DeWitt@osumc.edu
About this study
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.
Read the detailed description
This project will evaluate the effects of dry needling on pain, muscle performance, and function in those with patellofemoral pain syndrome (PFPS) of the knee. Variables of interest will include self-reported pain scores, self-reported functional outcome and disability questionnaire scores, and various objective clinical measures including muscle strength, joint range of motion, and movement patterns during basic tasks related to activities of daily living. Patients who are referred to physical therapy with PFPS will be recruited. Patients will be randomly and equally allocated into one of the following groups: 1. Gluteal dry needling (GLUTE) 2. Quadriceps dry needling (QUAD) 3. Sham gluteal dry needling (SHAM GLUTE) 4. Sham quadriceps dry needling (SHAM QUAD) 5. Control group (CONTROL) Groups 1-4 will receive 2 sessions of dry needling or sham dry needling to the gluteal and/or quadricpes muscles on their painful lower limb over 2 consecutive weeks in addition to standard physical therapy. The CONTROL group will only receive standard physical therapy. The sham treatment groups (groups 3-4) will receive a placebo treatment that does not penetrate the skin or muscles. Measurements will be performed at baseline prior to any physical therapy interventions and then at week 3.
- Being tested
- Dry Needling, Sham Dry Needling, Physical Therapy
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
Also called Trigger Point Acupunture
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 NeedlingDevice
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 TherapyOther
Also called Exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| Glute Dry Needling | Experimental | Receives dry needling to their gluteal muscles in addition to standard physical therapy treatment. Receives: Device: Dry Needling |
| Quad Dry Needling | Experimental | Receives dry needling to their quadriceps muscles in addition to standard physical therapy treatment. Receives: Device: Dry Needling |
| Glute Sham Dry Needling | Sham comparator | Receives sham dry needling to their gluteal muscles in addition to standard physical therapy treatment. Receives: 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. Receives: Device: Sham Dry Needling |
| Control | Active comparator | Receives only standard physical therapy treatment. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and Post testing (week 3)
Secondary outcomes (4)
Change from Baseline Lateral step-down (LSD) test score to 3 weeks
the LSD test will also be performed to evaluate movement quality. Two-dimensional video analysis and scoring will be conducted during the LSD test. Participants will be asked to stand with their stance foot close to the edge of a 20cm step and place their second toe over a white piece of tape, while their non-stance limb is off the side of the step. Participants will be asked to keep both hands on their waist and bend their knee until the heel of their uninvolved leg lightly touched the floor, then to immediately return to the starting position. Participants will be instructed to perform 5 trials and will be scored on the 4th trial. Immediately following the test, participants will rate any knee pain experienced during the test as described above. The LSD test has been shown to have moderate reliability.
Measured: Baseline and Post testing (week 3)
Change from Baseline Isometric knee and hip peak torque values to 3 weeks
Isometric knee and hip peak torque will be measured for knee extension, knee flexion, hip abduction, and hip extension using a Biodex System III dynamometer (Biodex Medical Systems, Inc. Shirley, New York, USA) on each subject's pain and non-painful limb . A standardize set-up and protocol commonly performed in clinical care and based on manufacture guidelines will be used. Peak torque during each task will be recorded as absolute values (Nm) and normalized to body mass (Nm/kg). The data from the strength testing will be used to power future studies evaluating the effects of dry needling on muscle force generation.
Measured: Baseline and Post testing (week 3)
Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks
The LEFS is commonly used self report questionnaire to evaluate function in patients with patellofemoral pain syndrome (PFPS) and other lower extremity problems.
Measured: Baseline and Post testing (week 3)
Change from Baseline Pressure Pain Threshold to 3 weeks
Pressure pain threshold (PPT) will be used to measure pain sensitivity and potential abnormalities in pain processing. PPT measures have been shown to have excellent intra-rater (ICC=0.94-0.97) and inter-rater reliability (ICC=0.72-0.90). A digital pressure algometer will be used to measure PPT at 5 sites [3 sites around the patella, 1 site at the center of the patella, and 1 site on the tibialis anterior].
Measured: Baseline and Post testing (week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matt Briggs, Ohio State University
- Investigators
- Matthew S Briggs, DPT, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890485
- Sponsor's protocol ID
- 2016H0003
- Status last verified
- Feb 2026
- First submitted
- 29 Aug 2016
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dry Needling on Patients With Knee Pain
- ClinicalTrials.gov ID
- NCT02890485
- Acronym / sponsor ID
- 2016H0003
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project will evaluate the effects of dry needling on pain, muscle performance, and function in those with patellofemoral pain syndrome (PFPS) of the knee. Variables of interest will include self-reported pain scores, self-reported functional outcome and disability questionnaire scores, and various objective clinical measures including muscle strength, joint range of motion, and movement patterns during basic tasks related to activities of daily living. Patients who are referred to physical therapy with PFPS will be recruited. Patients will be randomly and equally allocated into one of the following groups: 1. Gluteal dry needling (GLUTE) 2. Quadriceps dry needling (QUAD) 3. Sham gluteal dry needling (SHAM GLUTE) 4. Sham quadriceps dry needling (SHAM QUAD) 5. Control group (CONTROL) Groups 1-4 will receive 2 sessions of dry needling or sham dry needling to the gluteal and/or quadricpes muscles on their painful lower limb over 2 consecutive weeks in addition to standard physical therapy. The CONTROL group will only receive standard physical therapy. The sham treatment groups (groups 3-4) will receive a placebo treatment that does not penetrate the skin or muscles. Measurements will be performed at baseline prior to any physical therapy interventions and then at week 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Glute Dry Needling | Experimental | Device: Dry NeedlingReceives dry needling to their gluteal muscles in addition to standard physical therapy treatment. |
| Quad Dry Needling | Experimental | Device: Dry NeedlingReceives dry needling to their quadriceps muscles in addition to standard physical therapy treatment. |
| Glute Sham Dry Needling | Sham comparator | Device: Sham Dry NeedlingReceives sham dry needling to their gluteal muscles in addition to standard physical therapy treatment. |
| Quad Sham Dry Needling | Sham comparator | Device: Sham Dry NeedlingReceives sham dry needling to their quadriceps muscles in addition to standard physical therapy treatment. |
| Control | Active comparator | Other: Physical TherapyReceives only standard physical therapy treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- Unable to provide consent
- Bilateral patellofemoral pain syndrome
- Received previous dry needling treatments
- Pregnancy
- History of pain less than 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingAlso: Trigger Point AcupuntureDry 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. | Device | Glute Dry Needling, Quad Dry Needling |
| Sham Dry NeedlingThe 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. | Device | Glute Sham Dry Needling, Quad Sham Dry Needling |
| Physical TherapyAlso: ExercisePhysical 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. | Other | Control |
Primary outcome
Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks
Time frame: Baseline and Post testing (week 3)
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).
Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks
Time frame: Baseline and Post testing (week 3)
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).
4 secondary outcomes
Change from Baseline Lateral step-down (LSD) test score to 3 weeks
Time frame: Baseline and Post testing (week 3)
Change from Baseline Isometric knee and hip peak torque values to 3 weeks
Time frame: Baseline and Post testing (week 3)
Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks
Time frame: Baseline and Post testing (week 3)
Change from Baseline Pressure Pain Threshold to 3 weeks
Time frame: Baseline and Post testing (week 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew S Briggs, DPT, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Physical Therapy in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kat Rethman, DPT (614-293-2385, katherine.rethman@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks (time frame: Baseline and Post testing (week 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.