The Effects of Dry Needling on Patients with Knee Pain

NCT ID: NCT02890485

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2026-12-31

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.

Conditions

Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glute Dry Needling

Receives dry needling to their gluteal muscles in addition to standard physical therapy treatment.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: DEVICE

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.

Quad Dry Needling

Receives dry needling to their quadriceps muscles in addition to standard physical therapy treatment.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: DEVICE

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.

Glute Sham Dry Needling

Receives sham dry needling to their gluteal muscles in addition to standard physical therapy treatment.

Group Type: SHAM_COMPARATOR

Sham Dry Needling

Intervention Type: DEVICE

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.

Quad Sham Dry Needling

Receives sham dry needling to their quadriceps muscles in addition to standard physical therapy treatment.

Group Type: SHAM_COMPARATOR

Sham Dry Needling

Intervention Type: DEVICE

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.

Control

Receives only standard physical therapy treatment.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Trigger Point Acupunture; Exercise

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Matt Briggs

Assistant Professor-Practice

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew S Briggs, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kat Rethman, DPT

Role: CONTACT

katherine.rethman@osumc.edu

614-293-2385

Cody Mansfield, DPT

Role: CONTACT

cody.mansfield@osumc.edu

714-609-1904

Facility Contacts

Erik Hemenway, PTA

Role: primary

Erik.Hemenway@osumc.edu

614-293-2385

John DeWitt, DPT

Role: backup

John.DeWitt@osumc.edu

614-293-2385

Other Identifiers

2016H0003

Identifier Type: -

Identifier Source: org_study_id