Patellofemoral Pain Syndrome Clinical Trial
Official title:
Clinical Comparison of Patellofemoral Pain Syndrome Outcomes After Blood Flow Restriction Therapy
Verified date | October 2023 |
Source | Gaylord Hospital, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if Blood Flow Restriction therapy improves patient related outcomes in those diagnosed with Patellofemoral Pain Syndrome compared to those in the sham comparator control group.
Status | Terminated |
Enrollment | 1 |
Est. completion date | October 10, 2023 |
Est. primary completion date | October 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: Diagnosis of patellofemoral pain syndrome (PFPS) or non-specific anterior knee pain (NSAKP) and plan to attend Gaylord Specialty Healthcare Physical Therapy Exclusion Criteria: Member of a defined vulnerable population, women who are or suspected to be pregnant, prisoners, children under 15, or other protected populations Body mass of the leg preventing the cuff from fitting properly Radiographic evidence of osteoarthritis (= Kellgren-Lawrence Grade 2) History of intra-articular injection into either knee within 3 -months Uncontrolled or untreated inflammatory disorder Acute inflammatory disorder Uncontrolled Diabetes and/or peripheral neuropathy, impaired circulation Uncontrolled cardiac conditions including uncontrolled hypertension Areas of thrombophlebitis, thrombosis Distal wounds or pain below the knee >4/10 History of or current rhabdomyolysis Prolonged immobilization (>3 months) Sickle cell anemia Lymphadenectomy Varicose veins, or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis Current infection at or below the level of cuff placement Malignancies in or below the area to be treated Other conditions/medications that would interfere with subject safety or data collection in the opinion of the PI Subjects with an increased risk of non-response as determined by the therapist Once entered in the study, a diagnosis change that affects participation |
Country | Name | City | State |
---|---|---|---|
United States | Gaylord Specialty Healthcare Outpatient Physical Therapy; Cheshire | Cheshire | Connecticut |
United States | Gaylord Specialty Healthcare Outpatient Physical Therapy; Cromwell | Cromwell | Connecticut |
United States | University of Connecticut Health Center | Farmington | Connecticut |
United States | Gaylord Specialty Healthcare Outpatient Physical Therapy; Madison | Madison | Connecticut |
United States | Gaylord Hospital | Wallingford | Connecticut |
United States | Gaylord Specialty Healthcare Outpatient Physical Therapy; Wallingford | Wallingford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Gaylord Hospital, Inc | UConn Health |
United States,
Brightwell BD, Stone A, Li X, Hardy P, Thompson K, Noehren B, Jacobs C. Blood flow Restriction training After patellar INStability (BRAINS Trial). Trials. 2022 Jan 28;23(1):88. doi: 10.1186/s13063-022-06017-1. — View Citation
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Collins NJ, Bierma-Zeinstra SM, Crossley KM, van Linschoten RL, Vicenzino B, van Middelkoop M. Prognostic factors for patellofemoral pain: a multicentre observational analysis. Br J Sports Med. 2013 Mar;47(4):227-33. doi: 10.1136/bjsports-2012-091696. Epub 2012 Dec 13. — View Citation
Constantinou A, Mamais I, Papathanasiou G, Lamnisos D, Stasinopoulos D. Comparing hip and knee focused exercises versus hip and knee focused exercises with the use of blood flow restriction training in adults with patellofemoral pain. Eur J Phys Rehabil Med. 2022 Apr;58(2):225-235. doi: 10.23736/S1973-9087.22.06691-6. Epub 2022 Jan 5. — View Citation
Dolak KL, Silkman C, Medina McKeon J, Hosey RG, Lattermann C, Uhl TL. Hip strengthening prior to functional exercises reduces pain sooner than quadriceps strengthening in females with patellofemoral pain syndrome: a randomized clinical trial. J Orthop Sports Phys Ther. 2011 Aug;41(8):560-70. doi: 10.2519/jospt.2011.3499. Epub 2011 Jun 7. Erratum In: J Orthop Sports Phys Ther. 2011 Sep;41(9):700. — View Citation
Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12. — View Citation
Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27. — View Citation
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Lankhorst NE, van Middelkoop M, Crossley KM, Bierma-Zeinstra SM, Oei EH, Vicenzino B, Collins NJ. Factors that predict a poor outcome 5-8 years after the diagnosis of patellofemoral pain: a multicentre observational analysis. Br J Sports Med. 2016 Jul;50(14):881-6. doi: 10.1136/bjsports-2015-094664. Epub 2015 Oct 13. — View Citation
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Misra G, Paris TA, Archer DB, Coombes SA. Dose-response effect of isometric force production on the perception of pain. PLoS One. 2014 Feb 4;9(2):e88105. doi: 10.1371/journal.pone.0088105. eCollection 2014. — View Citation
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Song JS, Spitz RW, Yamada Y, Bell ZW, Wong V, Abe T, Loenneke JP. Exercise-induced hypoalgesia and pain reduction following blood flow restriction: A brief review. Phys Ther Sport. 2021 Jul;50:89-96. doi: 10.1016/j.ptsp.2021.04.005. Epub 2021 Apr 23. — View Citation
Thiebaud RS, Yasuda T, Loenneke JP, Abe T. Effects of low-intensity concentric and eccentric exercise combined with blood flow restriction on indices of exercise-induced muscle damage. Interv Med Appl Sci. 2013 Jun;5(2):53-9. doi: 10.1556/IMAS.5.2013.2.1. Epub 2013 Jul 4. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Pain Rating Scale: Enrollment | The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours | This assessment will be collected upon enrollment in the study. | |
Primary | Numeric Pain Rating Scale: 1 Week | The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours | This assessment will be collected 1-week into treatment | |
Primary | Numeric Pain Rating Scale: 4 Weeks | The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours | This assessment will be collected 4-weeks into treatment. | |
Primary | Numeric Pain Rating Scale: 9 Weeks/Discharge | The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours | This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first. | |
Primary | Numeric Pain Rating Scale: 6 Months | The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours | This assessment will be collected 6 months post start date. | |
Primary | Numeric Pain Rating Scale: 12 Months | The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours | This assessment will be collected 12 months post start date. | |
Primary | Lower Extremity Functional Scale: Enrollment | The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome | This assessment will be collected upon enrollment in the study. | |
Primary | Lower Extremity Functional Scale: 1 Week | The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome | This assessment will be collected 1-week into treatment. | |
Primary | Lower Extremity Functional Scale: 4 Weeks | The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome | This assessment will be collected 4-weeks into treatment. | |
Primary | Lower Extremity Functional Scale: 9 Weeks/Discharge | The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome | This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first. | |
Primary | Lower Extremity Functional Scale: 6 Months | The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome | This assessment will be collected 6 months post start date. | |
Primary | Lower Extremity Functional Scale: 12 Months | The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome | This assessment will be collected 12 months post start date. | |
Primary | Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: Enrollment | The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms | This assessment will be collected upon enrollment in the study. | |
Primary | Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 1 Week | The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms | This assessment will be collected1-week into treatment. | |
Primary | Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 4 Weeks | The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms | This assessment will be collected 4-weeks into treatment. | |
Primary | Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 9 Weeks/Discharge | The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms | This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first. | |
Primary | Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 6 Months | The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms | This assessment will be collected 6 months post start date. | |
Primary | Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 12 Months | The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms | This assessment will be collected 12 months post start date. | |
Primary | Single Assessment Numerical Evaluation: Enrollment | The SANE is a two item questionnaire used globally to assess function | This assessment will be collected upon enrollment in the study. | |
Primary | Single Assessment Numerical Evaluation: 1 Week | The SANE is a two item questionnaire used globally to assess function | This assessment will be collected 1-week into treatment. | |
Primary | Single Assessment Numerical Evaluation: 4 Weeks | The SANE is a two item questionnaire used globally to assess function | This assessment will be collected 4-weeks into treatment. | |
Primary | Single Assessment Numerical Evaluation: 9 Weeks/Discharge | The SANE is a two item questionnaire used globally to assess function | This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first. | |
Primary | Single Assessment Numerical Evaluation: 6 Months | The SANE is a two item questionnaire used globally to assess function | This assessment will be collected 6 months post start date. | |
Primary | Single Assessment Numerical Evaluation: 12 Months | The SANE is a two item questionnaire used globally to assess function | This assessment will be collected 12 months post start date. | |
Primary | Tenger Activity Scale: Enrollment | The Tenger Activity Scale aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. | This assessment will be collected upon enrollment. | |
Primary | Tenger Activity Scale: 6 Months | The Tenger Activity Scale aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. | This assessment will be collected 6 months post start date. | |
Primary | Tenger Activity Scale: 12 Months | The Tenger Activity Scale aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. | This assessment will be collected 12 months post start date. | |
Primary | Fear Avoidance Beliefs Questionnaire: Enrollment | The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain | This assessment will be collected upon enrollment in the study. | |
Primary | Fear Avoidance Beliefs Questionnaire: 1 Week | The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain | This assessment will be collected 1-week into treatment. | |
Primary | Fear Avoidance Beliefs Questionnaire: 4 Weeks | The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain | This assessment will be collected 4-weeks into treatment. | |
Primary | Fear Avoidance Beliefs Questionnaire: 9 Weeks/Discharge | The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain | This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first. | |
Primary | Fear Avoidance Beliefs Questionnaire: 6 Months | The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain | This assessment will be collected 6 months post start date. | |
Primary | Fear Avoidance Beliefs Questionnaire: 12 Months | The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain | This assessment will be collected 12 months post start date. | |
Secondary | Quadricep Isometric Strength: Enrollment | Quadricep Isometric Strength is the amount of strength shown in a patient's quadricep muscle via isometric dynomometry | This assessment will be collected upon enrollment in the study. | |
Secondary | Quadricep Isometric Strength: 1 Week | Quadricep Isometric Strength is the amount of strength shown in a patient's quadricep muscle via isometric dynomometry | This assessment will be collected 1-week into treatment. | |
Secondary | Quadricep Isometric Strength: 4 Weeks | Quadricep Isometric Strength is the amount of strength shown in a patient's quadricep muscle via isometric dynomometry | This assessment will be collected 4-weeks into treatment. | |
Secondary | Quadricep Isometric Strength: 9 Weeks/Discharge | Quadricep Isometric Strength is the amount of strength shown in a patient's quadricep muscle via isometric dynomometry | This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first. |
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