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

• ClinicalTrials.gov Identifier: NCT04748692
• Recruitment Status: Completed
• First Posted: February 10, 2021
• Last Update Posted: May 10, 2021
• Sponsor: Vrije Universiteit Brussel
• Collaborator: VU University of Amsterdam
• Information provided by (Responsible Party): Scafoglieri Aldo, Vrije Universiteit Brussel

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.

Condition or disease	Intervention/treatment	Phase
Patellofemoral Pain Syndrome	Procedure: Local exercise therapy; Procedure: Spinal manual therapy	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Double (Investigator, Outcomes Assessor)
• Masking Description: The allocation of the patients to their treatment group will be concealed from the researcher that assesses the outcome measures.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: January 28, 2021
• Actual Study Completion Date: January 28, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Local exercise therapy; 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.	Procedure: Local exercise therapy; 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.
Experimental: Spinal manual therapy; 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.	Procedure: Spinal manual therapy; 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.

Outcome Measures

Primary Outcome Measures :

1. Visual analogue scale [ Time Frame: before the first intervention (at baseline) ]
   Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
2. Visual analogue scale [ Time Frame: 6 weeks after the first intervention (at 6 weeks) ]
   Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
3. Visual analogue scale [ Time Frame: 6 weeks after the last intervention (at 12 weeks) ]
   Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
4. Functionality [ Time Frame: before the first intervention (baseline) ]
   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
5. Functionality [ Time Frame: 6 weeks after the first intervention (at 6 weeks) ]
   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
6. Functionality [ Time Frame: 6 weeks after the last intervention (at 12 weeks) ]
   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 :

1. Knee extension strength [ Time Frame: before the first intervention (baseline) ]
   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.
2. Knee extension strength [ Time Frame: 6 weeks after the first intervention (at 6 weeks) ]
   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.
3. Knee extension strength [ Time Frame: 6 weeks after the last intervention (at 12 weeks) ]
   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.

Other Outcome Measures:

1. Age [ Time Frame: before intervention (at baseline) ]
   self-reported age (in years)
2. Weight [ Time Frame: before intervention (at baseline) ]
   self-reported weight (in kg)
3. Height [ Time Frame: before intervention (at baseline) ]
   self-reported height (in cm)
4. Duration of symptoms [ Time Frame: before intervention (at baseline) ]
   self-reported duration of symptoms (in months)
5. Sport [ Time Frame: before intervention (at baseline) ]
   self-reported weekly participation in sport (Yes/No)
6. Previous exercise therapy [ Time Frame: before intervention (at baseline) ]
   self-reported previous exercise therapy treatment for the knee (Yes/No).
7. Chondral lesion [ Time Frame: before intervention (at baseline) ]
   Grade of patellofemoral chondral lesion (Grade 0, Grade 1, Grade 2) using Kellgren and Lawrence system for classification of osteoarthritis (X-ray)

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Vrije Universiteit Brussel

VU University of Amsterdam

Investigators

• Study Chair: Aldo Scafoglieri, Professor; Vrije Universiteit Brussel

More Information

Study Data/Documents: Individual Participant Data Set 

Access can be granted by the participant data set holder: Prof dr Aldo Scafoglieri

Publications of Results:

Fredericson M, Yoon K. Physical examination and patellofemoral pain syndrome. Am J Phys Med Rehabil. 2006 Mar;85(3):234-43. Review.

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.

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. Review.

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.

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. Review.

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.

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. Epub 2003 Sep 24.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Scafoglieri Aldo, Prof. dr. Aldo Scafoglieri, Vrije Universiteit Brussel
• ClinicalTrials.gov Identifier: NCT04748692
• Other Study ID Numbers: NL57207.096.16
• First Posted: February 10, 2021
• Last Update Posted: May 10, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: According to GDPR regulations upon reasonable request study results can be shared

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scafoglieri Aldo, Vrije Universiteit Brussel:

effectiveness; exercise therapy; manipulative therapy; medium term; randimozed controlled trial

Additional relevant MeSH terms:

Patellofemoral Pain Syndrome; Syndrome; Disease; Pathologic Processes; Joint Diseases; Musculoskeletal Diseases