Skip to main content
OpenTrials
Completed

NCT Number: NCT04748692

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Local exercise therapy

Procedure

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.

Spinal Manual Therapy

Procedure

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 outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Vrije Universiteit Brussel

Other

Collaborators

  • VU University of Amsterdam

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.