NCT02514005

Brief Summary

It is a randomized clinical trial comparing two treatments in patients affected by the patellofemoral syndrome (PFS). Our aim was to investigate the effectiveness of inclusion of trigger point dry needling into the management of idividuals with patellofemoral pain syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

9 months

First QC Date

July 27, 2015

Last Update Submit

October 25, 2016

Conditions

Patellofemoral Syndrome

Keywords

Trigger pointsManual therapyPatellofemoral syndromeDry needling

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Intensity patellofemoral pain before the treatment is evaluated after treatment and monitoring. The pain scale was removed by the KOOS scale (Knee Injury and Osteoarthritis Outcome Score): Pain levels were assessed: absent, mild or occasional pain climbing stairs, while driving, occasional moderate, moderately severe, severe. Being 0 to 50 points = severe pain (no pain).

    up to 3 months follow up

Secondary Outcomes (3)

  • IKDC (International Knee Documentation - Committee).

    up to 3 months follow up

  • KSS (Knee Society Score).

    up to 3 months follow up

  • KOOS (Knee Injury and Osteoarthritis Outcome Score).

    up to 3 months follow up

Study Arms (2)

Manual therapy

ACTIVE COMPARATOR

Overall bilateral manipulation (L5-S1-SI), Hip joint gapping, Stretching the hip rotators with hip and knee flexion, Femorotibial Gapping, Decompression of connective tissue of the patellofemoral region, Internal and external joint line opening in laterality, Mobilization of the base of the fibula, Tibiofibular-talus gapping, and Muscle strengthening.

Other: Manual therapy

Manual therapy and Dry needling

EXPERIMENTAL

Dry needling is performed in the MTrPs of the vastus lateralis and vastus medialis muscles of the quadriceps.

Other: Manual therapyDevice: Dry needling

Interventions

Manual therapyOTHER

\- Manual Therapy. Study treatment consists of a comprehensive joint treatment of the lumbar region and the lower limbs that are related to the biomechanics of the knee. In this way, the aim is to globally balance the possible dysfunctions that may exist in the lower lumbar region and sacroiliac joint, hip, knee and ankle.

Manual therapyManual therapy and Dry needling
Dry needlingDEVICE

* Manual therapy. Study treatment consists of a comprehensive joint treatment of the lumbar region and the lower limbs that are related to the biomechanics of the knee. In this way, the aim is to globally balance the possible dysfunctions that may exist in the lower lumbar region and sacroiliac joint, hip, knee and ankle. * Dry needling (DN). Dry needling is performed in the MTrPs of the vastus lateralis and vastus medialis muscles of the quadriceps.

Manual therapy and Dry needling

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 19 and 60 years.
  • Patients diagnosed with nonspecific patellofemoral syndrome. Positive sign in patellofemoral gliding test; Negetive McMurry test; Full knee range of motion; Anterior knee pain, related to prolonged sitting, climbing stairs, and descending stairs; No relevant patellofemoral degenerative changes on imaging; No history of knee trauma.

You may not qualify if:

  • Patients excluded from the study are those with osteoarthritis, recent injuries, ligament injuries, meniscal lesions, previous injury and / or treatments lasting for a period of 6 months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma V. Espí López

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

  • Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.

    PMID: 28504067DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Musculoskeletal ManipulationsDry Needling

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gemma gemma.espi@uv.es, PhD

    Department Physiotherapy. University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 3, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

ES(1)