Clinical Comparison of Patellofemoral Pain Syndrome Outcomes After Blood Flow Restriction Therapy

NCT05617911 | Terminated Results FDA Device

• 1 other identifier: 202209SOK
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome

Keywords

Blood Flow Restriction; Patellofemoral Pain Syndrome; Physical Therapy; Non-Specific Anterior Knee Pain

Outcome Measures

Primary Outcomes (33)

• 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.

• 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

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (4)

• Quadricep Isometric Strength: Enrollment

  This assessment will be collected upon enrollment in the study.

• Quadricep Isometric Strength: 1 Week

  This assessment will be collected 1-week into treatment.

• Quadricep Isometric Strength: 4 Weeks

  This assessment will be collected 4-weeks into treatment.

• Quadricep Isometric Strength: 9 Weeks/Discharge

  This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.

Study Arms (2)

Blood flow restriction and standard of care therapy

EXPERIMENTAL

The experimental BFR therapy will be incorporated into the standard therapy sessions and will not elongate the treatment session, quantity of sessions or incur any additional cost. As the participant progresses over time in therapy sessions, the discretion of the PT will determine when they have graduated beyond receiving any benefit from BFRT as demonstrated by quad strength.

Device: Blood Flow Restriction Cuff

Sham and standard of care therapy

PLACEBO COMPARATOR

The sham comparator control group will also follow the Exercise Protocol in their physical therapy sessions with a non inflated blood flow restriction cuff attached in the same position as the experimental group. Similar to the intervention group, as participant's progress in therapy, the Physical Therapist will use their clinical decision making to advance the person through resistance and repetition increases.

Procedure: Sham and standard of Care Therapy

Interventions

Blood Flow Restriction Cuff DEVICE

Blood Flow Restriction (BFR) involves the application of an external device to reduce arterial blood flow to the exercising area, while largely occluding venous return from that same area.

Blood flow restriction and standard of care therapy

Sham and standard of Care Therapy PROCEDURE

SoC PT + non-inflated BFR cuff

Sham and standard of care therapy

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of patellofemoral pain syndrome (PFPS) or non-specific anterior knee pain (NSAKP) and plan to attend Gaylord Specialty Healthcare Physical Therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead
• UConn Health: collaborator

Study Sites (6)

Gaylord Specialty Healthcare Outpatient Physical Therapy; Cheshire

Cheshire, Connecticut, 06410, United States

Location

Gaylord Specialty Healthcare Outpatient Physical Therapy; Cromwell

Cromwell, Connecticut, 06416, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Gaylord Specialty Healthcare Outpatient Physical Therapy; Madison

Madison, Connecticut, 06443, United States

Location

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Gaylord Specialty Healthcare Outpatient Physical Therapy; Wallingford

Wallingford, Connecticut, 06492, United States

Location

Related Publications (18)

• Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.

  PMID: 29324820 BACKGROUND

• 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.

  PMID: 23242955 BACKGROUND

• 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.

  PMID: 26463119 BACKGROUND

• Maclachlan LR, Matthews M, Hodges PW, Collins NJ, Vicenzino B. The psychological features of patellofemoral pain: a cross-sectional study. Scand J Pain. 2018 Apr 25;18(2):261-271. doi: 10.1515/sjpain-2018-0025.

  PMID: 29794307 BACKGROUND

• Post WR, Dye SF. Patellofemoral Pain: An Enigma Explained by Homeostasis and Common Sense. Am J Orthop (Belle Mead NJ). 2017 Mar/Apr;46(2):92-100.

  PMID: 28437494 BACKGROUND

• Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.

  PMID: 29392329 BACKGROUND

• Powers CM, Ho KY, Chen YJ, Souza RB, Farrokhi S. Patellofemoral joint stress during weight-bearing and non-weight-bearing quadriceps exercises. J Orthop Sports Phys Ther. 2014 May;44(5):320-7. doi: 10.2519/jospt.2014.4936. Epub 2014 Mar 27.

  PMID: 24673446 BACKGROUND

• Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.

  PMID: 29925502 BACKGROUND

• Kountouris A, Cook J. Rehabilitation of Achilles and patellar tendinopathies. Best Pract Res Clin Rheumatol. 2007 Apr;21(2):295-316. doi: 10.1016/j.berh.2006.12.003.

  PMID: 17512484 BACKGROUND

• 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.

  PMID: 33940556 BACKGROUND

• 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.

  PMID: 24505397 BACKGROUND

• 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.

  PMID: 32105522 BACKGROUND

• 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.

  PMID: 28500081 BACKGROUND

• 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.

  PMID: 34985237 BACKGROUND

• 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.

  PMID: 21654093 BACKGROUND

• Sisk D, Fredericson M. Update of Risk Factors, Diagnosis, and Management of Patellofemoral Pain. Curr Rev Musculoskelet Med. 2019 Dec;12(4):534-541. doi: 10.1007/s12178-019-09593-z.

  PMID: 31773479 BACKGROUND

• 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.

  PMID: 35090543 BACKGROUND

• 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.

  PMID: 24265891 BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: John Corbett
• Organization: Gaylord Hospital

jcorbett@gaylord.org

203-294-3224

Study Officials

• Eric Sokolowski

  Physical Therapist

  PRINCIPAL INVESTIGATOR

• Danielle Letendre

  Physical Therapist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 16, 2022
• Study Start: November 15, 2022
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available after analysis has been completed, and then will be available for 3 years after the date of completion.
• Access Criteria: Qualified researchers will be allowed access to the deidentified data, and any other documents at the discretion of the primary investigators and research team

Locations

US (6)