The Effects of Dry Needling on Patients With Knee Pain

Overview

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.

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 pres
• 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

Primary outcome measures

• Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks [Time frame: Baseline and Post testing (week 3)]
• Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks [Time frame: Baseline and Post testing (week 3)]

Secondary outcome measures (4)

• 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)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The Ohio State University Wexner Medical Center — Columbus

Identifiers

NCT: NCT02890485 · 2016H0003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗