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Withdrawn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
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome
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
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
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
Learn more about this trial
The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome
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