NCT03157271

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

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

December 15, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

May 15, 2017

Last Update Submit

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 INTERVENTION

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

PFPS Plus Dry Needling Treatment

EXPERIMENTAL

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

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.

Also known as: Trigger Point Dry Needling
PFPS Plus Dry Needling Treatment

Eligibility Criteria

Age14 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases
0

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