Clinical trial NCT02890485: The Effects of Dry Needling on Patients with Knee Pain
Official title: The Effects of Dry Needling on Patients with Knee Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Anterior Knee Pain Syndrome
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks
timeFrame: Baseline and Post testing (week 3)
measure: Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks
timeFrame: Baseline and Post testing (week 3)
Secondary outcomes:
measure: Change from Baseline Lateral step-down (LSD) test score to 3 weeks
timeFrame: Baseline and Post testing (week 3)
measure: Change from Baseline Isometric knee and hip peak torque values to 3 weeks
timeFrame: Baseline and Post testing (week 3)
measure: Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks
timeFrame: Baseline and Post testing (week 3)
measure: Change from Baseline Pressure Pain Threshold to 3 weeks
timeFrame: Baseline and Post testing (week 3)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Matthew S Briggs, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: