The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome

December 13, 2017 updated by: Duke University
Subjects between 14 and 40 years of age referred to physical therapy with a diagnosis of PFPS will be randomly assigned to one of two groups. The first group (PFPS) will be treated pragmatically. The second group (PFPS+DN) will receive the same pragmatic approach with the addition of dry needling intervention. The dry needling intervention will be delivered based on the treating physical therapist's examination of the patient's soft tissue mobility deficits, muscle activation deficits, or referred pain patterns.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All interventions delivered to both study groups will be provided by licensed physical therapists at Duke Sports Medicine. The frequency of visits and duration of physical therapy care will be determined on an individual basis. Both groups will be expected to perform an individualized home exercise program to supplement formal therapy visits. The PFPS group will receive a pragmatic treatment approach reflective of currently accepted interventions. The clinician will have the ability to select appropriate interventions based on the presentation/need of each patient. These interventions may include: stretching (iliotibial band, hip flexor, lateral retinaculum); patellar taping; kinesiology taping; bracing; joint mobilization (patella, ankle, hip); orthotics/footwear recommendations; pain modalities such as Ice, electric stimulation, laser; soft tissue mobilization (manual or instrument assisted) for restricted tissues such as peri-patellar tissues, iliotibial band, tensor fasciae latae, hamstrings, calf, quadriceps, hip flexors, and gluteals. The PFPS+DN group will be treated in the same manner described above with the addition of the dry needling intervention. The dry needling intervention will be prescriptive in that each provider will assess patient for the presence of a trigger point that may be contributing either directly or indirectly to the patient's symptoms and perform the intervention per the following guidelines. First, the presence of a trigger point must be verified by locating a palpable taught band, a hypersensitive tender area, referred pain of the MTrP in response to compression, a Jump Sign - response from patient who winces, may cry out, or withdraw, or a local twitch response provoked by manually snapping the taut band. Second, a muscle may be selected for dry needling if that muscle is assumed to be contributing to tissue extensibility restriction, motor control dysfunction, or hyperactivity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anterior or retro-patellar knee pain from at least two of the following: prolonged sitting, stair climbing, squatting, running, kneeling, and hopping/jumping.
  • Insidious onset of symptoms unrelated to trauma
  • Presence of pain on palpation of the patellar facets
  • Pain on compression of the patella

Exclusion Criteria:

  • Signs or symptoms of meniscal or other intra-articular pathologic condition.
  • Self-reported other knee pathology such as cartilage injury or ligamentous tear.
  • Known articular cartilage damage (from previously obtained imaging).
  • Ligament laxity or tenderness.
  • Patellar tendonitis, ITB syndrome, fracture,
  • Tenderness over the patellar tendon, ITB, tibial tubercle, or pes anserinus tendons "if reproduced the pain"
  • Patellar instability (positive apprehension sign and/or self-reported history of dislocations or subluxations.
  • Concurrent Hip Pain
  • Lumbar referred pain
  • Osgood-Schlatters or Sinding-Larsen-Johanssen Syndromes
  • Knee surgery within the past year
  • Evidence of effusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: PFPS Treatment
This arm (group of patients) will receive typical/pragmatically designed treatment for patellofemoral pain syndrome.
Experimental: PFPS Plus Dry Needling Treatment
This group will receive the same typical/pragmatically designed treatment for patellofemoral pain syndrome but with the addition of a dry needling intervention.
Other: Intramuscular Dry Needling
Dry Needling is a procedure in which a solid filament needle is inserted into the skin and muscle directly at a myofascial trigger point. A myofascial trigger point consists of multiple contraction knots, which are related to the production and maintenance of the pain cycle and interfere with movement patterns.
Other Names:
  • Trigger Point Dry Needling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Lower Extremity Functional Scale
Time Frame: Baseline, 2 weeks, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
20 Item Survey - Self report of difficulty with 20 lower extremity common tasks
Baseline, 2 weeks, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Subjective Report of Pain on a Scale from 0-10
Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Change in Global Function Rating
Time Frame: Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Subjective Rating for Physical Function on a Scale from 0-100%
Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Change in Global Rating of Change
Time Frame: Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Subjective Rating of Change since starting treatment scale of -7 (much worse) to +7 (much better)
Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00081677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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