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Effectiveness of Exercise Therapy Versus Spinal Manual Therapy in Patients With PFPS

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Local exercise therapy
Spinal manual therapy
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring effectiveness, exercise therapy, manipulative therapy, medium term, randimozed controlled trial

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • self-reported unilateral or
  • bilateral anterior knee pain provoked by at least two of the following activities: jumping, squatting, ascending/ descending stairs, kneeling, prolonged sitting and or a
  • positive patellar compression test

Exclusion Criteria:

  • experiencing pain for less than 3 months
  • a history of knee surgery
  • meniscal lesion
  • patellar subluxation/dislocation
  • evidence of tendinopathy or ligamentous pathologies
  • dislocation or fracture in the pelvic region
  • spinal surgery
  • osteoporosis
  • pregnancy
  • neurologic disorders
  • findings of chondromalacia > grade 2 on MRI, echography or X-ray.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Local exercise therapy

    Spinal manual therapy

    Arm Description

    The local exercise therapy group focused on strengthening knee and hip muscles three times a week for 6 weeks. Once a week, patients trained with the support of a physiotherapist. The physiotherapist gradually increased the intensity of the exercises improving muscle endurance. The exercises were supplemented with mobilisations of the patellofemoral joint. Twice a week, patients trained at home following a prescribed exercise program writing down their work-out in an exercise journal.

    The spinal manual therapy group was treated one a week for 6 weeks. Before the first intervention an experienced manual therapist performed a clinical examination of the lower back, SIJ, hip and knee. Anatomical maps showing innervation areas of spinal nerve roots were used to explain the regional interdependence model in the treatment of anterior knee pain. Manual therapy treatment included manipulations of the thoracolumbar (T12-L3) region or SIJ as well as hip joint. Manipulation was conducted if a restriction of range of motion was found in any of the regions. Patients were also asked to do home exercises focusing on mobilizing the thoracolumbar region and to write down their performance in an exercise journal.

    Outcomes

    Primary Outcome Measures

    Visual analogue scale
    Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
    Visual analogue scale
    Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
    Visual analogue scale
    Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
    Functionality
    Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100
    Functionality
    Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100
    Functionality
    Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100

    Secondary Outcome Measures

    Knee extension strength
    Maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings.
    Knee extension strength
    Maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings.
    Knee extension strength
    Maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings.

    Full Information

    First Posted
    January 28, 2021
    Last Updated
    May 5, 2021
    Sponsor
    Vrije Universiteit Brussel
    Collaborators
    VU University of Amsterdam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04748692
    Brief Title
    Effectiveness of Exercise Therapy Versus Spinal Manual Therapy in Patients With PFPS
    Official Title
    Effectiveness of Exercise Therapy Versus Spinal Manual Therapy in Patients With Patellofemoral Pain Syndrome: Medium Term Follow-up Results of a Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    January 28, 2021 (Actual)
    Study Completion Date
    January 28, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vrije Universiteit Brussel
    Collaborators
    VU University of Amsterdam

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Preliminary results of a pilot study in The Bergman Clinic Naarden (NL) show that a local exercise therapy group may decrease pain by 30% on the visual analogue scale (VAS) after 6 weeks. A reduction of 50% on the VAS was realized in a spinal manual therapy group. Therefore, the aim of this study is to compare the effectiveness of local exercise therapy versus spinal manual therapy in patients with PFPS after 6 weeks of intervention and at 6 weeks of follow-up. To the knowledge of the authors, the clinical effectiveness of spinal manual manipulations on pain, function and strength has not been investigated in the medium term.
    Detailed Description
    Interventions The local exercise therapy group will focus on strengthening knee and hip muscles three times a week for 6 weeks. Once a week, patients will train with the support of a physiotherapist. The physiotherapist gradually increases the intensity of the exercises improving muscle endurance. The exercises will be supplemented with mobilisations of the patellofemoral joint. Twice a week, patients train at home following a prescribed exercise program writing down their work-out in an exercise journal. The spinal manual therapy group will be treated one a week for 6 weeks. Before the first intervention an experienced manual therapist performed a clinical examination of the lower back, SIJ, hip and knee. Anatomical maps showing innervation areas of spinal nerve roots will be used to explain the regional interdependence model in the treatment of anterior knee pain. Manual therapy treatment will include manipulations of the thoracolumbar (T12-L3) region or SIJ as well as hip joint. Manipulation will be conducted if a restriction of range of motion will be found in any of the regions. Patients will also be asked to do home exercises focusing on mobilizing the thoracolumbar region and to write down their performance in an exercise journal. The allocation of the patients to their treatment group will be concealed from the researcher that assesses the outcome measures. Outcome measures The following baseline characteristics will be self-reported: age (in years), weight (in kg), height (in cm), duration of symptoms (in months), weekly participation in sport (yes/no), previously receiving exercise therapy treatment for the knee (yes/no). Patellofemoral chondral lesions will be graded using the Kellgren and Lawrence system for classification of osteoarthritis (grade 0 = definite absence of X-ray changes of osteoarthritis, grade 1 = doubtful joint space narrowing and possible osteophytic lipping, grade 2 = definite osteophytes and possible joint space narrowing). Knee pain, functionality and force will be measured using validated measurement instruments. Pain and functionality will be our primary outcomes. Maximum, minimum and current pain intensity will be indicated on a 0-100 mm VAS line. Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100. Our secondary outcome, maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings. Patients will be assessed before intervention (=baseline), at 6 weeks (=immediately after the last intervention) and at 12 weeks (=6 weeks after the last intervention).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellofemoral Pain Syndrome
    Keywords
    effectiveness, exercise therapy, manipulative therapy, medium term, randimozed controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study is a randomized controlled trial with a follow-up of 6 weeks. Patients with PFPS will be randomly assigned to one of two intervention groups using an online computer-based pseudo-random number generator on which the numbers were generated by use of a complex algorithm (seeded by the computer's clock). The flow diagram of the progress through the phases of the parallel randomised trial of both intervention groups (that is, enrolment, allocation, follow-up, and data analysis) follows the PRISMA statement.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    The allocation of the patients to their treatment group will be concealed from the researcher that assesses the outcome measures.
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Local exercise therapy
    Arm Type
    Experimental
    Arm Description
    The local exercise therapy group focused on strengthening knee and hip muscles three times a week for 6 weeks. Once a week, patients trained with the support of a physiotherapist. The physiotherapist gradually increased the intensity of the exercises improving muscle endurance. The exercises were supplemented with mobilisations of the patellofemoral joint. Twice a week, patients trained at home following a prescribed exercise program writing down their work-out in an exercise journal.
    Arm Title
    Spinal manual therapy
    Arm Type
    Experimental
    Arm Description
    The spinal manual therapy group was treated one a week for 6 weeks. Before the first intervention an experienced manual therapist performed a clinical examination of the lower back, SIJ, hip and knee. Anatomical maps showing innervation areas of spinal nerve roots were used to explain the regional interdependence model in the treatment of anterior knee pain. Manual therapy treatment included manipulations of the thoracolumbar (T12-L3) region or SIJ as well as hip joint. Manipulation was conducted if a restriction of range of motion was found in any of the regions. Patients were also asked to do home exercises focusing on mobilizing the thoracolumbar region and to write down their performance in an exercise journal.
    Intervention Type
    Procedure
    Intervention Name(s)
    Local exercise therapy
    Intervention Description
    The local exercise therapy group will focus on strengthening knee and hip muscles three times a week for 6 weeks. Once a week, patients will train with the support of a physiotherapist. The physiotherapist gradually increases the intensity of the exercises improving muscle endurance. The exercises will be supplemented with mobilisations of the patellofemoral joint. Twice a week, patients train at home following a prescribed exercise program writing down their work-out in an exercise journal.
    Intervention Type
    Procedure
    Intervention Name(s)
    Spinal manual therapy
    Intervention Description
    The spinal manual therapy group will be treated one a week for 6 weeks. Before the first intervention an experienced manual therapist performed a clinical examination of the lower back, SIJ, hip and knee. Anatomical maps showing innervation areas of spinal nerve roots will be used to explain the regional interdependence model in the treatment of anterior knee pain. Manual therapy treatment will include manipulations of the thoracolumbar (T12-L3) region or SIJ as well as hip joint. Manipulation will be conducted if a restriction of range of motion will be found in any of the regions. Patients will also be asked to do home exercises focusing on mobilizing the thoracolumbar region and to write down their performance in an exercise journal.
    Primary Outcome Measure Information:
    Title
    Visual analogue scale
    Description
    Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
    Time Frame
    before the first intervention (at baseline)
    Title
    Visual analogue scale
    Description
    Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
    Time Frame
    6 weeks after the first intervention (at 6 weeks)
    Title
    Visual analogue scale
    Description
    Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
    Time Frame
    6 weeks after the last intervention (at 12 weeks)
    Title
    Functionality
    Description
    Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100
    Time Frame
    before the first intervention (baseline)
    Title
    Functionality
    Description
    Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100
    Time Frame
    6 weeks after the first intervention (at 6 weeks)
    Title
    Functionality
    Description
    Functionality will be measured using the Dutch version of the anterior knee pain scale (AKPS). The AKPS questionnaire consists of 13 items assessing subjective symptoms and functional limitations totalling a maximum score of 100
    Time Frame
    6 weeks after the last intervention (at 12 weeks)
    Secondary Outcome Measure Information:
    Title
    Knee extension strength
    Description
    Maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings.
    Time Frame
    before the first intervention (baseline)
    Title
    Knee extension strength
    Description
    Maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings.
    Time Frame
    6 weeks after the first intervention (at 6 weeks)
    Title
    Knee extension strength
    Description
    Maximum voluntary peak force (MVPF) of the quadriceps, will be measured using a Biodex system 3 isokinetic dynamometer (Biodex Medical Systems, Inc., Shirley, NY, USA). This system has shown sufficient reliability and validity for position, torque and velocity measurements in clinical and research settings.
    Time Frame
    6 weeks after the last intervention (at 12 weeks)
    Other Pre-specified Outcome Measures:
    Title
    Age
    Description
    self-reported age (in years)
    Time Frame
    before intervention (at baseline)
    Title
    Weight
    Description
    self-reported weight (in kg)
    Time Frame
    before intervention (at baseline)
    Title
    Height
    Description
    self-reported height (in cm)
    Time Frame
    before intervention (at baseline)
    Title
    Duration of symptoms
    Description
    self-reported duration of symptoms (in months)
    Time Frame
    before intervention (at baseline)
    Title
    Sport
    Description
    self-reported weekly participation in sport (Yes/No)
    Time Frame
    before intervention (at baseline)
    Title
    Previous exercise therapy
    Description
    self-reported previous exercise therapy treatment for the knee (Yes/No).
    Time Frame
    before intervention (at baseline)
    Title
    Chondral lesion
    Description
    Grade of patellofemoral chondral lesion (Grade 0, Grade 1, Grade 2) using Kellgren and Lawrence system for classification of osteoarthritis (X-ray)
    Time Frame
    before intervention (at baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: self-reported unilateral or bilateral anterior knee pain provoked by at least two of the following activities: jumping, squatting, ascending/ descending stairs, kneeling, prolonged sitting and or a positive patellar compression test Exclusion Criteria: experiencing pain for less than 3 months a history of knee surgery meniscal lesion patellar subluxation/dislocation evidence of tendinopathy or ligamentous pathologies dislocation or fracture in the pelvic region spinal surgery osteoporosis pregnancy neurologic disorders findings of chondromalacia > grade 2 on MRI, echography or X-ray.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aldo Scafoglieri, Professor
    Organizational Affiliation
    Vrije Universiteit Brussel
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    According to GDPR regulations upon reasonable request study results can be shared
    Citations:
    PubMed Identifier
    16505640
    Citation
    Fredericson M, Yoon K. Physical examination and patellofemoral pain syndrome. Am J Phys Med Rehabil. 2006 Mar;85(3):234-43. doi: 10.1097/01.phm.0000200390.67408.f0.
    Results Reference
    result
    PubMed Identifier
    10220713
    Citation
    Suter E, McMorland G, Herzog W, Bray R. Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain. J Manipulative Physiol Ther. 1999 Mar-Apr;22(3):149-53. doi: 10.1016/S0161-4754(99)70128-4.
    Results Reference
    result
    PubMed Identifier
    24421619
    Citation
    Sueki DG, Cleland JA, Wainner RS. A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications. J Man Manip Ther. 2013 May;21(2):90-102. doi: 10.1179/2042618612Y.0000000027.
    Results Reference
    result
    PubMed Identifier
    18057674
    Citation
    Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007 Nov;37(11):658-60. doi: 10.2519/jospt.2007.0110. No abstract available.
    Results Reference
    result
    PubMed Identifier
    24766358
    Citation
    Kooiker L, Van De Port IG, Weir A, Moen MH. Effects of physical therapist-guided quadriceps-strengthening exercises for the treatment of patellofemoral pain syndrome: a systematic review. J Orthop Sports Phys Ther. 2014 Jun;44(6):391-402, B1. doi: 10.2519/jospt.2014.4127. Epub 2014 Apr 25.
    Results Reference
    result
    PubMed Identifier
    16461174
    Citation
    Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.
    Results Reference
    result
    PubMed Identifier
    14508689
    Citation
    Drouin JM, Valovich-mcLeod TC, Shultz SJ, Gansneder BM, Perrin DH. Reliability and validity of the Biodex system 3 pro isokinetic dynamometer velocity, torque and position measurements. Eur J Appl Physiol. 2004 Jan;91(1):22-9. doi: 10.1007/s00421-003-0933-0. Epub 2003 Sep 24.
    Results Reference
    result
    PubMed Identifier
    22814449
    Citation
    Almosnino S, Stevenson JM, Bardana DD, Diaconescu ED, Dvir Z. Reproducibility of isokinetic knee eccentric and concentric strength indices in asymptomatic young adults. Phys Ther Sport. 2012 Aug;13(3):156-62. doi: 10.1016/j.ptsp.2011.09.002. Epub 2011 Oct 22.
    Results Reference
    result
    PubMed Identifier
    33992100
    Citation
    Scafoglieri A, Van den Broeck J, Willems S, Tamminga R, van der Hoeven H, Engelsma Y, Haverkamp S. Effectiveness of local exercise therapy versus spinal manual therapy in patients with patellofemoral pain syndrome: medium term follow-up results of a randomized controlled trial. BMC Musculoskelet Disord. 2021 May 15;22(1):446. doi: 10.1186/s12891-021-04310-9.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://vub-my.sharepoint.com/:f:/g/personal/aldo_scafoglieri_vub_be/EspOeK0bPk9JgvUpkobVcZEB-fPjar_48PO4_aIq-JhsIw?e=Wsu4DC
    Available IPD/Information Comments
    Access can be granted by the participant data set holder: Prof dr Aldo Scafoglieri

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    Effectiveness of Exercise Therapy Versus Spinal Manual Therapy in Patients With PFPS

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