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

Effectiveness of Exercise Therapy Versus Spinal Manual Therapy in Patients With Patellofemoral Pain Syndrome: Medium Term Follow-up Results of a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Procedure: Local exercise therapy; Procedure: Spinal manual therapy

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.	before the first intervention (at baseline)
Visual analogue scale	Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.	6 weeks after the first intervention (at 6 weeks)
Visual analogue scale	Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.	6 weeks after the last intervention (at 12 weeks)
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	before the first intervention (baseline)
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	6 weeks after the first intervention (at 6 weeks)
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	6 weeks after the last intervention (at 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before the first intervention (baseline)
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.	6 weeks after the first intervention (at 6 weeks)
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.	6 weeks after the last intervention (at 12 weeks)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vrije Universiteit Brussel
• Collaborators: VU University of Amsterdam
• Investigators: Study Chair: Aldo Scafoglieri, Professor, Vrije Universiteit Brussel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 28, 2021
• Study Completion (Actual): January 28, 2021

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: effectiveness; exercise therapy; manipulative therapy; medium term; randimozed controlled trial
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Patellofemoral Pain Syndrome
• Other Study ID Numbers: NL57207.096.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: According to GDPR regulations upon reasonable request study results can be shared

Study Data/Documents

1. Individual Participant Data Set
   Information comments: Access can be granted by the participant data set holder: Prof dr Aldo Scafoglieri

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No