Manual Therapy and Dry Needling in Patellofemoral Syndrome (MTPSSFP)

October 25, 2016 updated by: GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

Effectiveness of Manual Therapy and Dry Needling in Nonspecific Patellofemoral Syndrome.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients The sample involved patients diagnosed with nonspecific patellofemoral syndrome. The treatment is carried out at the School of Physiotherapy (University of Valencia).

The study comprises patients with nonspecific patellofemoral syndrome. 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.

Study design It is a single-blind randomized controlled study. 3 sessions are conducted with 7-day intervals and 15 days for the last intervention and follow-up at 3 months after treatment ended. Each session lasts approximately 30 minutes.

The sample was divided into two groups:

  • Control group with manual therapy and strengthening exercises for the quadriceps and hamstrings.
  • Experimental group which receives manual therapy and strengthening exercises for the quadriceps and hamstrings combined with dry needling treatment (DN) in myofascial trigger points (MTrP) of vastus medialis and vastus lateralis of the quadriceps muscle and strengthening exercises for the quadriceps and hamstrings.

Intervention 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.

Assessment

The initial assessment is a clinical interview with the characteristics of the patellofemoral syndrome for the month prior to the study and for this, the following assessment instruments are used:

  • Intensity knee pain before the treatment is evaluated after treatment and monitoring.
  • KOOS (Knee Injury and Osteoarthritis Outcome Score). It assesses five dimensions: pain, symptoms, activities of daily living, sport and recreational activity and quality of life related to the knee. To evaluate osteoarthritis in older patients, the 24 WOMAC questions are included.
  • KSS (Knee Society Score). It is the modified scale of the American Knee Society. It makes it possible to separate the purely functional aspects of the knee joint, knee score, from those related to the patient's ability to walk and climb stairs, functional score.

It includes three main parameters (pain, stability and range of motion) and other parameters (contraction of flexion, loss of extension and alignment) considered as deductions to score of the former, possibly presenting some interobserver variation.

-IKDC (International Knee Documentation - Committee). It is an instrument to assess symptoms, function, and sport activity applicable to a variety of conditions of the knee. Validated for a variety of knee conditions including ligament, meniscal and articular cartilage injuries and also for osteoarthritis and patellofemoral pain.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • VAlencia, Spain, 46010
        • Gemma v. Espí López

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Manual therapy
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. 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.
Experimental: Manual therapy and Dry needling
Dry needling is performed in the MTrPs of the vastus lateralis and vastus medialis muscles of the quadriceps.
Other: Manual therapy
- 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.
Device: Dry needling
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: up to 3 months follow up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC (International Knee Documentation - Committee).
Time Frame: up to 3 months follow up
It is an instrument to assess symptoms, function, and sport activity applicable to a variety of conditions of the knee. Validated for a variety of knee conditions including ligament, meniscal and articular cartilage injuries and also for osteoarthritis and patellofemoral pain.
up to 3 months follow up
KSS (Knee Society Score).
Time Frame: up to 3 months follow up

It is the modified scale of the American Knee Society. It makes it possible to separate the purely functional aspects of the knee joint, knee score, from those related to the patient's ability to walk and climb stairs, functional score.

It includes three main parameters (pain, stability and range of motion) and other parameters (contraction of flexion, loss of extension and alignment) considered as deductions to score of the former, possibly presenting some interobserver variation.
up to 3 months follow up
KOOS (Knee Injury and Osteoarthritis Outcome Score).
Time Frame: up to 3 months follow up
It assesses five dimensions: pain, symptoms, activities of daily living, sport and recreational activity and quality of life related to the knee. To evaluate osteoarthritis in older patients, the 24 WOMAC questions are included.
up to 3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Investigators

  • Principal Investigator: Gemma gemma.espi@uv.es, PhD, Department Physiotherapy. University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 31, 2015

First Posted (Estimate)

August 3, 2015

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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