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The Effects of Dry Needling on Patients with Knee Pain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 40 Years
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02890485
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Ohio State University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Matthew S Briggs, DPT, PhD
Principal Investigator Affiliation Ohio State University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome
Additional Details

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.

Arms & Interventions

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

Device: - 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.

Device: - 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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43221

Site Contact

Erik Hemenway, PTA

[email protected]

614-293-2385

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