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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03157271
Recruitment Status : Withdrawn (Did not receive funding)
First Posted : May 17, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Intramuscular Dry Needling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
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 Name: Trigger Point Dry Needling




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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%

  3. 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)



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03157271    
Other Study ID Numbers: Pro00081677
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases