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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04748692
Enrollment
43
Registered
2021-02-10
Start date
2016-10-01
Completion date
2021-01-28
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Pain Syndrome

Keywords

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

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).

Interventions

PROCEDURELocal 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.

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.

Sponsors

VU University of Amsterdam
CollaboratorOTHER
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.

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.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scalebefore the first intervention (at baseline)Maximum, minimum and current pain intensity was indicated on a 0-100 mm VAS line.
Functionalitybefore 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

Secondary

MeasureTime frameDescription
Knee extension strengthbefore 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.

Other

MeasureTime frameDescription
Duration of symptomsbefore intervention (at baseline)self-reported duration of symptoms (in months)
Sportbefore intervention (at baseline)self-reported weekly participation in sport (Yes/No)
Agebefore intervention (at baseline)self-reported age (in years)
Chondral lesionbefore 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)
Previous exercise therapybefore intervention (at baseline)self-reported previous exercise therapy treatment for the knee (Yes/No).
Weightbefore intervention (at baseline)self-reported weight (in kg)
Heightbefore intervention (at baseline)self-reported height (in cm)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026