search
Back to results

The Effects of Dry Needling on Patients With Knee Pain

Primary Purpose

Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Sham Dry Needling
Physical Therapy
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Ohio State University Wexner Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Sham Comparator

Sham Comparator

Active Comparator

Arm Label

Glute Dry Needling

Quad Dry Needling

Glute Sham Dry Needling

Quad Sham Dry Needling

Control

Arm Description

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

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

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

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

Receives only standard physical therapy treatment.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
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.
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].

Full Information

First Posted
August 29, 2016
Last Updated
October 23, 2023
Sponsor
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT02890485
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glute Dry Needling
Arm Type
Experimental
Arm Description
Receives dry needling to their gluteal muscles in addition to standard physical therapy treatment.
Arm Title
Quad Dry Needling
Arm Type
Experimental
Arm Description
Receives dry needling to their quadriceps muscles in addition to standard physical therapy treatment.
Arm Title
Glute Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
Receives sham dry needling to their gluteal muscles in addition to standard physical therapy treatment.
Arm Title
Quad Sham Dry Needling
Arm Type
Sham Comparator
Arm Description
Receives sham dry needling to their quadriceps muscles in addition to standard physical therapy treatment.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Receives only standard physical therapy treatment.
Intervention Type
Procedure
Intervention Name(s)
Dry Needling
Other Intervention Name(s)
Trigger Point Acupunture
Intervention Description
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
Procedure
Intervention Name(s)
Sham Dry Needling
Intervention Description
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
Other
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks
Description
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).
Time Frame
Baseline and Post testing (week 3)
Title
Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks
Description
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).
Time Frame
Baseline and Post testing (week 3)
Secondary Outcome Measure Information:
Title
Change from Baseline Lateral step-down (LSD) test score to 3 weeks
Description
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.
Time Frame
Baseline and Post testing (week 3)
Title
Change from Baseline Isometric knee and hip peak torque values to 3 weeks
Description
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.
Time Frame
Baseline and Post testing (week 3)
Title
Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks
Description
The LEFS is commonly used self report questionnaire to evaluate function in patients with patellofemoral pain syndrome (PFPS) and other lower extremity problems.
Time Frame
Baseline and Post testing (week 3)
Title
Change from Baseline Pressure Pain Threshold to 3 weeks
Description
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].
Time Frame
Baseline and Post testing (week 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kat Rethman, DPT
Phone
614-293-2385
Email
katherine.rethman@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cody Mansfield, DPT
Phone
714-609-1904
Email
cody.mansfield@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew S Briggs, DPT, PhD
Organizational Affiliation
The Ohio State University Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Ganim, MPT
Phone
614-293-2385
Email
Anthony.Ganim@osumc.edu
First Name & Middle Initial & Last Name & Degree
John DeWitt, DPT
Phone
614-293-2385
Email
John.DeWitt@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Dry Needling on Patients With Knee Pain

We'll reach out to this number within 24 hrs