Patellofemoral SyndromeMTPSSFPNCT02514005
Manual Therapy and Dry Needling in Patellofemoral Syndrome
A study testing Manual therapy and Dry needling in people with Patellofemoral Syndrome, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Syndrome
- What is being tested?
- Manual therapy and Dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patellofemoral Syndrome
- Being tested
- Manual therapy, Dry needling
- Keywords
- Trigger points, Manual therapy, Patellofemoral syndrome, Dry needling
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Manual therapy; Device: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 3 months follow up
Secondary outcomes (3)
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.
Measured: up to 3 months follow up
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.
Measured: up to 3 months follow up
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.
Measured: up to 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral SyndromeStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- Gemma gemma.espi@uv.es, PhD, Principal investigator, Department Physiotherapy. University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02514005
- Sponsor's protocol ID
- ID007
- Acronym
- MTPSSFP
- Status last verified
- Oct 2016
- First submitted
- 27 Jul 2015
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28504067
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy and Dry Needling in Nonspecific Patellofemoral Syndrome.
- ClinicalTrials.gov ID
- NCT02514005
- Acronym / sponsor ID
- MTPSSFP / ID007
- Conditions
- Patellofemoral Syndrome
- Keywords
- Trigger points, Manual therapy, Patellofemoral syndrome, Dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Active comparator | Other: Manual therapyOverall 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. |
| Manual therapy and Dry needling | Experimental | Other: Manual therapy, Device: Dry needlingDry needling is performed in the MTrPs of the vastus lateralis and vastus medialis muscles of the quadriceps. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Manual therapy, Manual therapy and Dry needling |
| 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. | Device | Manual therapy and Dry needling |
Primary outcome
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).
3 secondary outcomes
IKDC (International Knee Documentation - Committee).
Time frame: up to 3 months follow up
KSS (Knee Society Score).
Time frame: up to 3 months follow up
KOOS (Knee Injury and Osteoarthritis Outcome Score).
Time frame: up to 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 28504067Espi-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gemma gemma.espi@uv.es, PhD principal investigator
Department Physiotherapy. University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Dry needling in people with Patellofemoral Syndrome, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: up to 3 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02514005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.