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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intramuscular Dry Needling
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    PFPS Treatment

    PFPS Plus Dry Needling Treatment

    Arm Description

    This arm (group of patients) will receive typical/pragmatically designed treatment for patellofemoral pain syndrome.

    This group will receive the same typical/pragmatically designed treatment for patellofemoral pain syndrome but with the addition of a dry needling intervention.

    Outcomes

    Primary Outcome Measures

    Change in Lower Extremity Functional Scale
    20 Item Survey - Self report of difficulty with 20 lower extremity common tasks

    Secondary Outcome Measures

    Change in Pain
    Subjective Report of Pain on a Scale from 0-10
    Change in Global Function Rating
    Subjective Rating for Physical Function on a Scale from 0-100%
    Change in Global Rating of Change
    Subjective Rating of Change since starting treatment scale of -7 (much worse) to +7 (much better)

    Full Information

    First Posted
    May 15, 2017
    Last Updated
    December 13, 2017
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03157271
    Brief Title
    The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome
    Official Title
    The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Did not receive funding
    Study Start Date
    October 2017 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke 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
    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.
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PFPS Treatment
    Arm Type
    No Intervention
    Arm Description
    This arm (group of patients) will receive typical/pragmatically designed treatment for patellofemoral pain syndrome.
    Arm Title
    PFPS Plus Dry Needling Treatment
    Arm Type
    Experimental
    Arm Description
    This group will receive the same typical/pragmatically designed treatment for patellofemoral pain syndrome but with the addition of a dry needling intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Intramuscular Dry Needling
    Other Intervention Name(s)
    Trigger Point Dry Needling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Lower Extremity Functional Scale
    Description
    20 Item Survey - Self report of difficulty with 20 lower extremity common tasks
    Time Frame
    Baseline, 2 weeks, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Pain
    Description
    Subjective Report of Pain on a Scale from 0-10
    Time Frame
    Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
    Title
    Change in Global Function Rating
    Description
    Subjective Rating for Physical Function on a Scale from 0-100%
    Time Frame
    Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
    Title
    Change in Global Rating of Change
    Description
    Subjective Rating of Change since starting treatment scale of -7 (much worse) to +7 (much better)
    Time Frame
    Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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