Patellofemoral Pain SyndromeNCT03985254
Do Power Exercises Result in Superior Benefits for People With Patellofemoral Pain?
A study testing Strength Training Group (STG) and Strength and Power Training Group (SPTG) in people with Patellofemoral Pain Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Patellofemoral pain (PFP) is one of the most common forms of knee pain and has a negative impact on the level of physical activity and quality of life of patients. Although strengthening of the hip and knee muscles has good clinical effects in the treatment of PFP, most exercise protocols do not follow the American… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Strength Training Group (STG) and Strength and Power Training Group (SPTG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to 1 Jul 2021
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- men and women with bilateral or unilateral patellofemoral pain
Who cannot join
- history of knee surgery
- history of hip or lumbar spine injury or pain
- patellar instability
- pain on palpation of the patellar tendon, iliotibial band, Hoffa fat, goose paw tendons or knee joint line
- signs or symptoms of meniscal or knee ligament injuries
- presence of Osgood-Schlatter syndrome or Sinding-Larsen-Johansson syndrome
- any vestibular, neurological or musculoskeletal alterations that interfere or contraindicate the procedures of this study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Gabriela Souza de Vasconcelos
São Carlos, São Paulo, 91360-010
Gabriela S de Vasconcelos, 51995372276, vasconcelosgs@gmail.com
About this study
Official title: Does Adding Power Exercises to Muscle Force Training Result in Superior Benefits for Patellofemoral Pain People? Randomized and Controlled Clinical Trial
Patellofemoral pain (PFP) is one of the most common forms of knee pain and has a negative impact on the level of physical activity and quality of life of patients. Although strengthening of the hip and knee muscles has good clinical effects in the treatment of PFP, most exercise protocols do not follow the American College of Sports Medicine (ACSM) guidelines and are not clearly described, making it difficult to apply them in practice clinical and research. In addition, recent studies have shown that these patients also have a power deficit of these muscles. However, it is not known whether the addition of power exercises to a muscle strengthening program would result in superior benefits, especially in relation to pain and physical function. Therefore, the objective of this study is to verify if the improvement in pain intensity, physical function, kinesiophobia, self perception of improvement, quality of life and muscle function variables after a training program of strength and muscular power is superior to that observed in an isolated muscle strength training. This study will be randomized and controlled, developed with individuals with DPF, allocated in one of two groups: Strength Training Group (STG) and Strength and Power Training Group (SPTG). The primary outcomes will be intensity of pain and physical function, while the secondary outcomes will be kinesiophobia; self perception of improvement; quality of life; the peak of isometric abductor and hip extensor torque, and knee extensor; and the rate of development of torque of the abductors and extensors of hip, and extensors of knee at 30% and 90% of maximum isometric torque. Participants in both groups will be evaluated before the intervention (pre), after the end of the intervention (post) and three, six and twelve months after the intervention. Data analysis will follow the intention-to-treat principle. To compare the groups at different times (pre, post and after three, six and twelve months of the intervention) will be used two-way analysis of variance (GROUP X MOMENT) with mixed model, with Bonferroni post hoc to identify specific differences. The significance level will be 0.05.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Strength Training Group (STG), Strength and Power Training Group (SPTG)
- 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.
Strength Training Group (STG)Other
The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015).
Initially, the goal will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]), and in subsequent weeks the goal will be the development of muscle strength (load> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included.
Strength and Power Training Group (SPTG)Other
Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]). However, in subsequent weeks the goal will be to develop strength (load> 70% 1RM) and muscle power (load between 40-60% 1RM).
| Study group | Role | What they receive |
|---|---|---|
| Strength Training Group (STG) | Active comparator | The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015).
Initially, the goal will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]), and in subsequent weeks the goal will be the development of muscle strength (load> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included. Receives: Other: Strength Training Group (STG) |
| Strength and Power Training Group (SPTG) | Experimental | Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]). However, in subsequent weeks the goal will be to develop strength (load> 70% 1RM) and muscle power (load between 40-60% 1RM). Receives: Other: Strength and Power Training Group (SPTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain Intensity at 12 weeks
Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating extremely intense pain. Participants will indicate their usual pain and their worst pain during the last week (CROSSLEY et al, 2004). The VAS scores will be computed by measuring the length of the line, in millimeters, from the left end (without pain) until the mark made by the participant.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)
Change from baseline physical function at 12 weeks
The Anterior Knee Pain Scale, a translated and validated Portuguese version (DA CUNHA et al, 2013), will be used to evaluate subjective symptoms, such as anterior knee pain and functional limitations related to PFP. The items assessed in the questionnaire are patellar subluxation, lameness, pain, walking, climbing stairs and remaining seated for prolonged time with knees flexed. It has scores of 0 to 100 points, where 100 means no pain and / or functional limitations and 0 means constant pain and several functional limitations (KUJALA et al, 1993). The Anterior Knee Pain Scale is a reliable and valid instrument to evaluate the function in individuals with PFP (CROSSLEY et al, 2004). The final score will be used for statistical analysis.
Measured: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)
Secondary outcomes (4)
Kinesiophobia
The kinesiophobia will be assessed using the translated and validated version of the Tampa Scale for Kinesiophobia questionnaire (SIQUEIRA et al, 2007), which is composed of 17 items that evaluate fear of movement, injury or recurrence of injury (MILLER, 1991). This questionnaire is a four-point Likert scale, in which the sum of responses can vary from 17 to 68, and scores greater than 37 indicate the presence of kinesiophobia.
Measured: Pre (baseline) treatment and post treatment (12 weeks)
Self-perception of improvement
The global rating of change (GRC) scale is a 15-point, single-item scale that measures the patient's im¬pression of improvement in health status following treatment (JAESCHKE et al, 1989). The scale is scored from -7 (a very great deal worse) to +7 (a very great deal better), with 0 (zero) indicating that there was no change. Changes of 4 points or more in this scale were previously considered to be clinically important in patients with knee pain.
Measured: Pre (baseline) treatment and post treatment (12 weeks)
Change Quality of Life
Participants' quality of life will be assessed through the Knee Injury and Osteoarthritis Outcome Score (KOOS). This questionnaire is composed of 42 items, divided into 5 sub-scales, which assess: pain, symptoms, function in sports and recreational activities, function in daily life activities and quality of life in adults with knee injuries (ligaments, meniscal) including post-traumatic osteoarthrosis. In the present study, only the sub-scale of quality of life will be applied to participants. This sub-scale is composed of four questions and each one will be scored from 0 to 4, 0 representing extreme knee problems and 4 that there are no problems in the knee. The sum of these questions will be used for further analysis.
Measured: Pre (baseline) treatment and post treatment (12 weeks)
Maximal Isometric Torque and Rate of Force Development (RFD)
The maximal isometric torque of the hip abductors and extensors, and knee extensors, as the rate of force development, will be assessed using an isokinetic dynamometer (Biodex MultiJoint System 3, Biodex Medical Systems Inc., New York, USA), with a sampling frequency of 100 Hz.
To calculate the RFD of the hip abductors and extensors and knee extensors, the data of the repetitions in which the participants reached the highest isometric torque will also be used (NUNES et al, 2018). The normalized torque data will be exported and processed in Matlab software.
The evaluation of the RFD will be performed by calculating the slope of the torque/time curve. The slope will be obtained by dividing the normalized torque variation (Nm/kg × 100, represented as %) by the time variation (ms) from the start of the contraction until 30% and 90% of the maximal isometric torque (BELLEW, 2002; CHANG et al, 2005).
Measured: Pre (baseline) treatment and post treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Aug 2019
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Souza de Vasconcelos, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985254
- Sponsor's protocol ID
- LaiotUFSCAR
- Status last verified
- Aug 2019
- First submitted
- 10 Jun 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vasconcelos GS, Nunes GS, Munhoz RF, da Silva MECB, Pisani GK, Luz BC, Serrao FV. Is strength and power training targeting hip and knee muscles superior to strength training in individuals with patellofemoral pain? Proof of concept study. Sci Rep. 2024 Nov 10;14(1):27450. doi: 10.1038/s41598-024-78074-2.
PubMed 39523423de Vasconcelos GS, Nunes GS, Barton CJ, Munhoz RF, da Silva MECB, Pisani GK, Luz BC, Serrao FV. Adding muscle power exercises to a strength training program for people with patellofemoral pain: protocol of a randomized controlled trial. Trials. 2021 Nov 6;22(1):777. doi: 10.1186/s13063-021-05748-x.
PubMed 34742328
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Power Exercises to Muscle Force Training Result in Superior Benefits for Patellofemoral Pain People? Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03985254
- Acronym / sponsor ID
- LaiotUFSCAR
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 13 Jun 2019 (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.
Patellofemoral pain (PFP) is one of the most common forms of knee pain and has a negative impact on the level of physical activity and quality of life of patients. Although strengthening of the hip and knee muscles has good clinical effects in the treatment of PFP, most exercise protocols do not follow the American College of Sports Medicine (ACSM) guidelines and are not clearly described, making it difficult to apply them in practice clinical and research. In addition, recent studies have shown that these patients also have a power deficit of these muscles. However, it is not known whether the addition of power exercises to a muscle strengthening program would result in superior benefits, especially in relation to pain and physical function. Therefore, the objective of this study is to verify if the improvement in pain intensity, physical function, kinesiophobia, self perception of improvement, quality of life and muscle function variables after a training program of strength and muscular power is superior to that observed in an isolated muscle strength training. This study will be randomized and controlled, developed with individuals with DPF, allocated in one of two groups: Strength Training Group (STG) and Strength and Power Training Group (SPTG). The primary outcomes will be intensity of pain and physical function, while the secondary outcomes will be kinesiophobia; self perception of improvement; quality of life; the peak of isometric abductor and hip extensor torque, and knee extensor; and the rate of development of torque of the abductors and extensors of hip, and extensors of knee at 30% and 90% of maximum isometric torque. Participants in both groups will be evaluated before the intervention (pre), after the end of the intervention (post) and three, six and twelve months after the intervention. Data analysis will follow the intention-to-treat principle. To compare the groups at different times (pre, post and after three, six and twelve months of the intervention) will be used two-way analysis of variance (GROUP X MOMENT) with mixed model, with Bonferroni post hoc to identify specific differences. The significance level will be 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strength Training Group (STG) | Active comparator | Other: Strength Training Group (STG)The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015). Initially, the goal will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]), and in subsequent weeks the goal will be the development of muscle strength (load> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included. |
| Strength and Power Training Group (SPTG) | Experimental | Other: Strength and Power Training Group (SPTG)Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]). However, in subsequent weeks the goal will be to develop strength (load> 70% 1RM) and muscle power (load between 40-60% 1RM). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- men and women with bilateral or unilateral patellofemoral pain
Key exclusion criteria (7 listed)
- history of knee surgery
- history of hip or lumbar spine injury or pain
- patellar instability
- pain on palpation of the patellar tendon, iliotibial band, Hoffa fat, goose paw tendons or knee joint line
- signs or symptoms of meniscal or knee ligament injuries
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 |
|---|---|---|
| Strength Training Group (STG)The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015). Initially, the goal will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]), and in subsequent weeks the goal will be the development of muscle strength (load> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included. | Other | Strength Training Group (STG) |
| Strength and Power Training Group (SPTG)Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]). However, in subsequent weeks the goal will be to develop strength (load> 70% 1RM) and muscle power (load between 40-60% 1RM). | Other | Strength and Power Training Group (SPTG) |
Primary outcome
Change from baseline pain Intensity at 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)
Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating extremely intense pain. Participants will indicate their usual pain and their worst pain during the last week (CROSSLEY et al, 2004). The VAS scores will be computed by measuring the length of the line, in millimeters, from the left end (without pain) until the mark made by the participant.
Change from baseline physical function at 12 weeks
Time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)
The Anterior Knee Pain Scale, a translated and validated Portuguese version (DA CUNHA et al, 2013), will be used to evaluate subjective symptoms, such as anterior knee pain and functional limitations related to PFP. The items assessed in the questionnaire are patellar subluxation, lameness, pain, walking, climbing stairs and remaining seated for prolonged time with knees flexed. It has scores of 0 to 100 points, where 100 means no pain and / or functional limitations and 0 means constant pain and several functional limitations (KUJALA et al, 1993). The Anterior Knee Pain Scale is a reliable and valid instrument to evaluate the function in individuals with PFP (CROSSLEY et al, 2004). The final score will be used for statistical analysis.
4 secondary outcomes
Kinesiophobia
Time frame: Pre (baseline) treatment and post treatment (12 weeks)
Self-perception of improvement
Time frame: Pre (baseline) treatment and post treatment (12 weeks)
Change Quality of Life
Time frame: Pre (baseline) treatment and post treatment (12 weeks)
Maximal Isometric Torque and Rate of Force Development (RFD)
Time frame: Pre (baseline) treatment and post treatment (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 39523423Vasconcelos GS, Nunes GS, Munhoz RF, da Silva MECB, Pisani GK, Luz BC, Serrao FV. Is strength and power training targeting hip and knee muscles superior to strength training in individuals with patellofemoral pain? Proof of concept study. Sci Rep. 2024 Nov 10;14(1):27450. doi: 10.1038/s41598-024-78074-2.
- Derived from this study: PubMed 34742328de Vasconcelos GS, Nunes GS, Barton CJ, Munhoz RF, da Silva MECB, Pisani GK, Luz BC, Serrao FV. Adding muscle power exercises to a strength training program for people with patellofemoral pain: protocol of a randomized controlled trial. Trials. 2021 Nov 6;22(1):777. doi: 10.1186/s13063-021-05748-x.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training Group (STG) and Strength and Power Training Group (SPTG) in people with Patellofemoral Pain Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 1 inclusion and 7 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 28 Aug 2019. 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 Brazil. 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 Gabriela S de Vasconcelos, MsC (+5551995372276, vasconcelosgs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain Intensity at 12 weeks (time frame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)). The study lists 2 primary outcomes in all. 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 NCT03985254, which also lists 2 linked publications.
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 28 Aug 2019.