Study Stopped
Did not receive funding
The Addition of Dry Needling in the Treatment of Patients With Patellofemoral Pain Syndrome
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedDecember 15, 2017
August 1, 2017
1.7 years
May 15, 2017
December 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Lower Extremity Functional Scale
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 Outcomes (3)
Change in Pain
Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Change in Global Function Rating
Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Change in Global Rating of Change
Baseline, Days 1-15, 1 month, at completion of treatment (average of 10 weeks), 3 months, 6 months
Study Arms (2)
PFPS Treatment
NO INTERVENTIONThis arm (group of patients) will receive typical/pragmatically designed treatment for patellofemoral pain syndrome.
PFPS Plus Dry Needling Treatment
EXPERIMENTALThis group will receive the same typical/pragmatically designed treatment for patellofemoral pain syndrome but with the addition of a dry needling intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2017
First Posted
May 17, 2017
Study Start
October 1, 2017
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
December 15, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share