Patellofemoral Pain SyndromeNCT04478422
Muscle Training With and Without Vascular Occlusion of Women With Patellofemoral Pain Syndrome: A Random Clinical Trial
A study testing Muscle strengthening with vascular occlusion and Conventional muscle strengthening in people with Patellofemoral Pain Syndrome and Vascular Occlusion, run by Christiane Macedo at 1 site in Brazil.
Trial summary
Introduction: The treatment of Patellofemoral Pain Syndrome (PFPS) uses the strengthening of the knee and hip muscles. Studies propose the use of partial vascular occlusion (OVP) of the quadriceps muscle to increase muscle strength and endurance, without joint overload or discomfort to the patient. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome, Vascular Occlusion
- What is being tested?
- Muscle strengthening with vascular occlusion and Conventional muscle strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2021to 30 Sep 2023
- 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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Insidious onset of symptoms unrelated to trauma, pain for at least three months; pain greater than three (3/10) in at least three of the functional activities (squatting for a long time, going up or down stairs, kneeling, running, remaining in a sitting position for a long time), maximum 86 points on the Anterior Knee Pain Scale (AKPS).
Who cannot join
- Signs and symptoms of other coexisting knee pathologies (arthrosis, prostheses, meniscal and ligament injuries), pain in other joints of the lower limb; lumbar spine pain, neurological, rheumatological, vascular and metabolic diseases; pregnancy; history of lower limb surgery; corticosteroid injection in the knee applied in the last three months, physiotherapy for knee rehabilitation in the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Muscle Training Program With and Without Vascular Occlusion in Pain, Functionality, Postural Control and Muscular Recruitment of Women With Patellophemoral Pain Syndrome: A Random Clinical Trial
Introduction: The treatment of Patellofemoral Pain Syndrome (PFPS) uses the strengthening of the knee and hip muscles. Studies propose the use of partial vascular occlusion (OVP) of the quadriceps muscle to increase muscle strength and endurance, without joint overload or discomfort to the patient. However, there is no consensus on the use in individuals with PFPS. Objective: To establish the effect of quadriceps muscle strengthening with OVP and low resistance to exercise on pain, functionality, postural control and muscle recruitment in women with patellofemoral dysfunction. Methods: Women with PFPS (n = 20) will respond to pain and functionality scales. The postural control and muscle recruitment of the quadriceps will also be evaluated in dynamic activities of single-legged squat and up / down stairs using a force platform and surface electromyography. After the initial assessment, the participants will be randomized into two groups: conventional quadriceps strengthening with greater resistance loads to exercise and quadriceps strengthening with OVP and low loads. And they will perform a six-week treatment protocol with exercises to strengthen the quadriceps. At the end of the intervention protocols, all of them will be reassessed immediately, after four and eight weeks. Expected Results: It is expected that the group submitted to exercises with OVP and lower load will present the same results of postural control and muscle recruitment compared to the conventional strengthening group. These results will indicate the possibility of using exercises and loads with less joint impairment.
- Conditions
- Patellofemoral Pain Syndrome, Vascular Occlusion
- Being tested
- Muscle strengthening with vascular occlusion, Conventional muscle strengthening
- Keywords
- Patellofemoral Pain Syndrome, Partial Vascular Occlusion, Postural Balance, Electromyography, Physical Therapy.
- 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.
Muscle strengthening with vascular occlusionOther
The muscle strengthening group with partial vascular occlusion will perform the strengthening exercises: single leg squat on 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat. The equipment for vascular occlusion will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). If necessary, the pressure can be adjusted at intervals and after the end of the exercise, an interval of 5 minutes is suggested for blood reperfusion.
Conventional muscle strengtheningOther
The conventional muscle strengthening group perform the same exercises as the intervention group: One-legged squat on a 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat, however, without restriction on blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Muscle strengthening with vascular occlusion | Experimental | Quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, with partial occlusion to blood flow. The occlusion equipment will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). Receives: Other: Muscle strengthening with vascular occlusion |
| Conventional muscle strengthening | Active comparator | Conventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow. Receives: Other: Conventional muscle strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain in the knee by scale score
Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.
Measured: pre-intervention, immediately after, after four weeks
Change in functional capacity by scale score
Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functional capacity.
Measured: pre-intervention, immediately after, after four weeks
Change in functional capacity by scale score
Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functional capacity.
Measured: pre-intervention, immediately after, after four weeks
Secondary outcomes (3)
Change in Muscle activition by electromyography variables
Muscle activition by surface electromyography of the quadriceps will be evaluated during one-legged squat activity and up and down stairs.
Measured: pre-intervention, immediately after, after four weeks
Change in quadriceps muscle strength
Change in quadriceps muscle strength by portable dynamometry
Measured: pre-intervention, immediately after, after four weeks
Change in Postural control by pressure center variables
Evaluation of postural control using a force platform will be evaluated during one-legged squat activity and up and down stairs.
Measured: pre-intervention, immediately after, after four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Feb 2021
- Primary completion31 May 2021
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiane Macedo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christiane Macedo, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478422
- Sponsor's protocol ID
- Vascular Occlusion in PFPS
- Status last verified
- Dec 2023
- First submitted
- 10 Jul 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Clin J Sport Med. 2017 May;27(3):245-252. doi: 10.1097/JSM.0000000000000377.
PubMed 27749358Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.
PubMed 26971109Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, DE Sa-Pinto AL, Roschel H. Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. Med Sci Sports Exerc. 2018 May;50(5):897-905. doi: 10.1249/MSS.0000000000001530.
PubMed 29266093Giles LS, Webster KE, McClelland JA, Cook J. Does quadriceps atrophy exist in individuals with patellofemoral pain? A systematic literature review with meta-analysis. J Orthop Sports Phys Ther. 2013 Nov;43(11):766-76. doi: 10.2519/jospt.2013.4833. Epub 2013 Sep 9.
PubMed 24175596Thijs KM, Zwerver J, Backx FJ, Steeneken V, Rayer S, Groenenboom P, Moen MH. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy: A Double-Blinded Randomized Study. Clin J Sport Med. 2017 Mar;27(2):89-96. doi: 10.1097/JSM.0000000000000332.
PubMed 27347857
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Muscle Training Program With and Without Vascular Occlusion in Pain, Functionality, Postural Control and Muscular Recruitment of Women With Patellophemoral Pain Syndrome: A Random Clinical Trial
- ClinicalTrials.gov ID
- NCT04478422
- Acronym / sponsor ID
- Vascular Occlusion in PFPS
- Conditions
- Patellofemoral Pain Syndrome, Vascular Occlusion
- Keywords
- Patellofemoral Pain Syndrome, Partial Vascular Occlusion, Postural Balance, Electromyography, Physical Therapy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Christiane MacedoUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 Jul 2020 (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.
Introduction: The treatment of Patellofemoral Pain Syndrome (PFPS) uses the strengthening of the knee and hip muscles. Studies propose the use of partial vascular occlusion (OVP) of the quadriceps muscle to increase muscle strength and endurance, without joint overload or discomfort to the patient. However, there is no consensus on the use in individuals with PFPS. Objective: To establish the effect of quadriceps muscle strengthening with OVP and low resistance to exercise on pain, functionality, postural control and muscle recruitment in women with patellofemoral dysfunction. Methods: Women with PFPS (n = 20) will respond to pain and functionality scales. The postural control and muscle recruitment of the quadriceps will also be evaluated in dynamic activities of single-legged squat and up / down stairs using a force platform and surface electromyography. After the initial assessment, the participants will be randomized into two groups: conventional quadriceps strengthening with greater resistance loads to exercise and quadriceps strengthening with OVP and low loads. And they will perform a six-week treatment protocol with exercises to strengthen the quadriceps. At the end of the intervention protocols, all of them will be reassessed immediately, after four and eight weeks. Expected Results: It is expected that the group submitted to exercises with OVP and lower load will present the same results of postural control and muscle recruitment compared to the conventional strengthening group. These results will indicate the possibility of using exercises and loads with less joint impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle strengthening with vascular occlusion | Experimental | Other: Muscle strengthening with vascular occlusionQuadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, with partial occlusion to blood flow. The occlusion equipment will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). |
| Conventional muscle strengthening | Active comparator | Other: Conventional muscle strengtheningConventional quadriceps strengthening exercises will be performed in isometric, concentric and eccentric phases, without occlusion to blood flow. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Insidious onset of symptoms unrelated to trauma, pain for at least three months; pain greater than three (3/10) in at least three of the functional activities (squatting for a long time, going up or down stairs, kneeling, running, remaining in a sitting position for a long time), maximum 86 points on the Anterior Knee Pain Scale (AKPS).
Key exclusion criteria (1 listed)
- Signs and symptoms of other coexisting knee pathologies (arthrosis, prostheses, meniscal and ligament injuries), pain in other joints of the lower limb; lumbar spine pain, neurological, rheumatological, vascular and metabolic diseases; pregnancy; history of lower limb surgery; corticosteroid injection in the knee applied in the last three months, physiotherapy for knee rehabilitation in the last six months.
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 |
|---|---|---|
| Muscle strengthening with vascular occlusionThe muscle strengthening group with partial vascular occlusion will perform the strengthening exercises: single leg squat on 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat. The equipment for vascular occlusion will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). If necessary, the pressure can be adjusted at intervals and after the end of the exercise, an interval of 5 minutes is suggested for blood reperfusion. | Other | Muscle strengthening with vascular occlusion |
| Conventional muscle strengtheningThe conventional muscle strengthening group perform the same exercises as the intervention group: One-legged squat on a 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat, however, without restriction on blood flow. | Other | Conventional muscle strengthening |
Primary outcome
Change in Pain in the knee by scale score
Time frame: pre-intervention, immediately after, after four weeks
Through Visual Analog Scale (VAS). The score ranges from 0 to 10, the higher the score, the greater the pain.
Change in functional capacity by scale score
Time frame: pre-intervention, immediately after, after four weeks
Using the Anterior Knee Pain Scale. The score ranges from 0 to 100, the higher the score, the better the functional capacity.
Change in functional capacity by scale score
Time frame: pre-intervention, immediately after, after four weeks
Using the Lysholm questionnaires. The score ranges from 0 to 100, the higher the score, the better the functional capacity.
3 secondary outcomes
Change in Muscle activition by electromyography variables
Time frame: pre-intervention, immediately after, after four weeks
Change in quadriceps muscle strength
Time frame: pre-intervention, immediately after, after four weeks
Change in Postural control by pressure center variables
Time frame: pre-intervention, immediately after, after four weeks
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 12 Dec 2023.
- Background: PubMed 27749358Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Clin J Sport Med. 2017 May;27(3):245-252. doi: 10.1097/JSM.0000000000000377.
- Background: PubMed 26971109Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.
- Background: PubMed 29266093Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, DE Sa-Pinto AL, Roschel H. Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. Med Sci Sports Exerc. 2018 May;50(5):897-905. doi: 10.1249/MSS.0000000000001530.
- Background: PubMed 24175596Giles LS, Webster KE, McClelland JA, Cook J. Does quadriceps atrophy exist in individuals with patellofemoral pain? A systematic literature review with meta-analysis. J Orthop Sports Phys Ther. 2013 Nov;43(11):766-76. doi: 10.2519/jospt.2013.4833. Epub 2013 Sep 9.
- Background: PubMed 27347857Thijs KM, Zwerver J, Backx FJ, Steeneken V, Rayer S, Groenenboom P, Moen MH. Effectiveness of Shockwave Treatment Combined With Eccentric Training for Patellar Tendinopathy: A Double-Blinded Randomized Study. Clin J Sport Med. 2017 Mar;27(2):89-96. doi: 10.1097/JSM.0000000000000332.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle strengthening with vascular occlusion and Conventional muscle strengthening in people with Patellofemoral Pain Syndrome and Vascular Occlusion, run by Christiane Macedo 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 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 12 Dec 2023. 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?
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?
Change in Pain in the knee by scale score (time frame: pre-intervention, immediately after, after four weeks). 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?
On the ClinicalTrials.gov record for NCT04478422, which also lists 5 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 12 Dec 2023.