Manual Therapy and Dry Needling in Patellofemoral Syndrome

Patellofemoral Syndrome Clinical Trial

— MTPSSFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514005
• Other study ID #: ID007
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: October 25, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Patellofemoral Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Gemma V. Espí López	VAlencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	up to 3 months follow up	Yes
Secondary	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.	up to 3 months follow up	Yes
Secondary	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.	up to 3 months follow up	Yes