Patellofemoral Pain SyndromeNCT03324204
Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain
A study testing Neuromuscular Training and Extracorporeal Shock Wave Therapy (ESWT) in people with Patellofemoral Pain Syndrome and Knee Pain Chronic, run by Medical University of Silesia at 1 site in Poland.
Trial summary
The aim of the trial is to compare the efficacy of extracorporeal shock wave therapy (ESWT) versus neuromuscular training (TR) in reducing pain in women with patellofemoral pain (PFP). Women with PFP will be randomly divided into two therapeutic groups: ESWT and TR. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome, Knee Pain Chronic
- What is being tested?
- Neuromuscular Training and Extracorporeal Shock Wave Therapy (ESWT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2014to 1 Jan 2019
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Knee pain for more than three months greater than three on the visual analogue scale (VAS) during at least two out of four typical activities:
- ascending or descending the stairs,
- prolonged sitting with flexed knee,
- running or jumping,
- squatting or kneeling.
Who cannot join
- Orthopaedic diagnosis other than PFP.
- Patients with neurological disorders, history of injury or operations within the symptomatic leg, rheumatoid disease, or pregnancy were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
Katowice, Silesian Voivodeship, 40-752
Magdalena Dąbrowska-Galas, Phd, 515321323 ext. 048, magdalena.j.dabrowska@gmail.com
About this study
The aim of the trial is to compare the efficacy of extracorporeal shock wave therapy (ESWT) versus neuromuscular training (TR) in reducing pain in women with patellofemoral pain (PFP). Women with PFP will be randomly divided into two therapeutic groups: ESWT and TR. The ESWT group will undergo extracorporeal shock wave therapy to the iliotibial band and tensor fascia latae. The TR group will be treated with neuromuscular training. The women's gait will be analysed and the strength of hip abductors and internal rotators will be measured. Additionally, the women's pain and health status will be assessed with the visual analogue scale and the Lysholm Scale. Outcomes will be registered at baseline, and then at five weeks and at three months post-therapy
- Conditions
- Patellofemoral Pain Syndrome, Knee Pain Chronic
- Being tested
- Neuromuscular Training, Extracorporeal Shock Wave Therapy (ESWT)
- 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.
Neuromuscular TrainingOther
Each session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis was placed on proper knee alignment during exercise. Most of the women exhibited excessive medial rotation and adduction of the femur, resulting in knee valgus, although knee varus was also observed. The women were instructed how to correct their abnormalities using mirrors as visual feedback. All exercises were completed without pain. If the exercises were too easy, the level of difficulty was increased individually in accordance with the rehabilitation protocol
Extracorporeal Shock Wave Therapy (ESWT)Other
ESWT will be applied to the iliotibial band and tensor fascia latae muscle with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training | Experimental | Each session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis is placed on proper knee alignment during exercise. Most of the women exhibit excessive medial rotation and adduction of the femur, resulting in knee valgus. The women will be instructed how to correct their abnormalities using mirrors as visual feedback. All exercises will be completed without pain. If the exercises are too easy, the level of difficulty will be increased individually in accordance with the rehabilitation protocol Receives: Other: Neuromuscular Training |
| Shock Wave Therapy | Active comparator | The ESWT group will will meet the therapist twice in the first week, and once a week after it. ESWT will be applied to the iliotibial band and tensor fascia latae with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session. Receives: Other: Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale is used to assess the subjective Pain.
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Measured: Outcome measures are obtained at baseline (pre-intervention)
Visual Analog Scale is used to assess the subjective Pain.
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Measured: Outcome measures are obtained, at five weeks after intervention.
Visual Analog Scale is used to assess the subjective Pain.
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Measured: Outcome measures are obtained at three months after intervention
Secondary outcomes (9)
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
The women walk on the treadmill barefoot for three minutes in order to become accustomed to the speed belt. After that time, the angles of the joints are measured for 30 seconds. Internal rotation is demarcated at the highest peak in midstance when the contralateral limb is in the terminal stance (toe-off phase). Hip adduction is determined at the highest peak in midstance
Measured: Outcome measures are obtained at baseline (pre-intervention)
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
The women walk on the treadmill barefoot for three minutes in order to become accustomed to the speed belt. After that time, the angles of the joints are measured for 30 seconds. Internal rotation is demarcated at the highest peak in midstance when the contralateral limb is in the terminal stance (toe-off phase). Hip adduction is determined at the highest peak in midstance
Measured: Outcome measures are obtained, at five weeks after intervention.
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
The women walk on the treadmill barefoot for three minutes in order to become accustomed to the speed belt. After that time, the angles of the joints are measured for 30 seconds. Internal rotation is demarcated at the highest peak in midstance when the contralateral limb is in the terminal stance (toe-off phase). Hip adduction is determined at the highest peak in midstance
Measured: Outcome measures are obtained at three months after intervention
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Muscle strength of lateral rotators, abductors of the hip is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants a of re asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Measured: Outcome measures are obtained at baseline (pre-intervention)
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Muscle strength of lateral rotators, abductors of the hip is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants a of re asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Measured: Outcome measures are obtained, at five weeks after intervention.
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Muscle strength of lateral rotators, abductors of the hip is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants a of re asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Measured: Outcome measures are obtained at three months after intervention
The self-reported health status is measured using the Lysholm Questionaire (LQ)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Measured: Outcome measures are obtained at baseline (pre-intervention)
The self-reported health status is measured using the Lysholm Questionaire (LQ)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Measured: Outcome measures are obtained, at five weeks after intervention.
The self-reported health status is measured using the Lysholm Questionaire (LQ)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Measured: Outcome measures are obtained at three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Aug 2014
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piotr Michalik, Medical University of Silesia
- Investigators
- Mgdalena Dabrowska-Galas, PhD, Study chair, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324204
- Sponsor's protocol ID
- kolanostudentki
- Status last verified
- Oct 2017
- First submitted
- 18 Jul 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT03324204
- Acronym / sponsor ID
- kolanostudentki
- Conditions
- Patellofemoral Pain Syndrome, Knee Pain Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 27 Oct 2017 (actual)
- 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.
The aim of the trial is to compare the efficacy of extracorporeal shock wave therapy (ESWT) versus neuromuscular training (TR) in reducing pain in women with patellofemoral pain (PFP). Women with PFP will be randomly divided into two therapeutic groups: ESWT and TR. The ESWT group will undergo extracorporeal shock wave therapy to the iliotibial band and tensor fascia latae. The TR group will be treated with neuromuscular training. The women's gait will be analysed and the strength of hip abductors and internal rotators will be measured. Additionally, the women's pain and health status will be assessed with the visual analogue scale and the Lysholm Scale. Outcomes will be registered at baseline, and then at five weeks and at three months post-therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training | Experimental | Other: Neuromuscular TrainingEach session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis is placed on proper knee alignment during exercise. Most of the women exhibit excessive medial rotation and adduction of the femur, resulting in knee valgus. The women will be instructed how to correct their abnormalities using mirrors as visual feedback. All exercises will be completed without pain. If the exercises are too easy, the level of difficulty will be increased individually in accordance with the rehabilitation protocol |
| Shock Wave Therapy | Active comparator | Other: Extracorporeal Shock Wave Therapy (ESWT)The ESWT group will will meet the therapist twice in the first week, and once a week after it. ESWT will be applied to the iliotibial band and tensor fascia latae with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Knee pain for more than three months greater than three on the visual analogue scale (VAS) during at least two out of four typical activities:
- ascending or descending the stairs,
- prolonged sitting with flexed knee,
- running or jumping,
- squatting or kneeling.
Key exclusion criteria (2 listed)
- Orthopaedic diagnosis other than PFP.
- Patients with neurological disorders, history of injury or operations within the symptomatic leg, rheumatoid disease, or pregnancy were also excluded from 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 |
|---|---|---|
| Neuromuscular TrainingEach session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis was placed on proper knee alignment during exercise. Most of the women exhibited excessive medial rotation and adduction of the femur, resulting in knee valgus, although knee varus was also observed. The women were instructed how to correct their abnormalities using mirrors as visual feedback. All exercises were completed without pain. If the exercises were too easy, the level of difficulty was increased individually in accordance with the rehabilitation protocol | Other | Neuromuscular Training |
| Extracorporeal Shock Wave Therapy (ESWT)ESWT will be applied to the iliotibial band and tensor fascia latae muscle with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session | Other | Shock Wave Therapy |
Primary outcome
Visual Analog Scale is used to assess the subjective Pain.
Time frame: Outcome measures are obtained at baseline (pre-intervention)
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Visual Analog Scale is used to assess the subjective Pain.
Time frame: Outcome measures are obtained, at five weeks after intervention.
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Visual Analog Scale is used to assess the subjective Pain.
Time frame: Outcome measures are obtained at three months after intervention
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
9 secondary outcomes
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Time frame: Outcome measures are obtained at baseline (pre-intervention)
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Time frame: Outcome measures are obtained, at five weeks after intervention.
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Time frame: Outcome measures are obtained at three months after intervention
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Time frame: Outcome measures are obtained at baseline (pre-intervention)
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Time frame: Outcome measures are obtained, at five weeks after intervention.
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Time frame: Outcome measures are obtained at three months after intervention
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Time frame: Outcome measures are obtained at baseline (pre-intervention)
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Time frame: Outcome measures are obtained, at five weeks after intervention.
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Time frame: Outcome measures are obtained at three months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
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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.
Mgdalena Dabrowska-Galas, PhD study chair
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular Training and Extracorporeal Shock Wave Therapy (ESWT) in people with Patellofemoral Pain Syndrome and Knee Pain Chronic, run by Medical University of Silesia at 1 site in Poland.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Oct 2017. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Michalik (694979743 ext. 0048, piotrmichalikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale is used to assess the subjective Pain. (time frame: Outcome measures are obtained at baseline (pre-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2017.