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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Patellofemoral Pain Syndrome

Intervention / Treatment
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* Procedure: Local exercise therapy
* Procedure: Spinal manual therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local exercise therapy<br>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<br>* 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.<br>|
| Experimental: Spinal manual therapy<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness, exercise therapy, manipulative therapy, medium term, randimozed controlled trial