Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome



Status:Completed
Conditions:Chronic Pain, Psychiatric
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:12 - Any
Updated:1/26/2018
Start Date:June 2015
End Date:October 2017

Use our guide to learn which trials are right for you!

Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial

Patients with PFPS demonstrate quadriceps and hip musculature weakness, altered lower
extremity (LE) kinematics, and decreased LE flexibility. Psychosocial factors have also been
identified as an important factor in patients with PFPS. The authors hypothesize that an
ordered approach addressing each of these impairments sequentially will result in greater
improvement in PFPS symptoms. The results of the investigators pilot study assessing the
feasibility of using a sequential approach showed a full randomized controlled trial is
warranted, the authors now plan to proceed with a full trial. The objective of this study is
to assess the efficacy of a sequential approach in the treatment of Patellofemoral Pain
Syndrome.

Methods: Patients will be randomized to a sequential treatment approach using a PFPS
treatment algorithm (PFPS Algorithm) designed by the authors or typical physical therapy
care. Due to the constant evaluation necessary no blinding will be performed. Patients will
attend therapy two times per week for six weeks. Pain, Anterior Knee Pain Scale (AKPS), and
Global Rating of Change (GROC) will be measured at evaluation and discharge, 3 month
follow-up and 6 month follow-up.

Patellofemoral pain syndrome (PFPS) accounts for 25 to 40% of knee pain in young and active
individuals. PFPS is described as anterior knee pain around the patella which is aggravated
by activity, particularly activities that increase patellofemoral forces such as squatting,
ascending or descending stairs, running, and jumping. It is common in adolescents and
physically active adults. Females are more likely to experience PFPS than males. PFPS is a
multi-factorial condition with no clear etiology and is considered a syndrome and not a
diagnosis. Dye has described PFPS as one of the most difficult orthopedic conditions to
manage.

Multiple theories exist regarding a cause for PFPS pain. A primary theory for the cause of
PFPS is abnormal patellar tracking which results in excessive patellofemoral joint
compressive forces. Many factors contributing to abnormal patellar tracking have been
suggested including; hip and quadriceps weakness, delayed or diminished activation of vastus
medialis obliquus, increased Q-angle, altered lower extremity mechanics and decreased lower
extremity flexibility. Due to the number of suggested contributory factors to PFPS pain, a
vast amount of interventions exist and are frequently used by clinicians. Although, physical
therapy interventions have been shown to be effective over sham interventions, many
individuals will have recurrent or chronic pain. Ninety-six percent of patients report having
problems four years following their diagnosis of PFPS. A possible reason for the continued
pain is that PFPS is a multi-factorial condition and the treatments may not address all of
the contributing factors in each individual.

If all of the contributing factors for the patient's PFPS are identified, addressing all of
these factors at once may not be the best approach. Performing hip strengthening prior to
quadriceps strengthening results in decreased levels of pain with exercise. Individuals with
reduced flexibility are more likely to have impaired lower extremity mechanics. Performing
traditional lower extremity strengthening exercises when there is impaired lower extremity
mechanics results in increased patellofemoral joint contact forces.

In an attempt to better treat individuals with PFPS, classification systems to subgroup
patients with PFPS have been proposed, but their effectiveness has not been evaluated. An
important clinical question with classification systems is what to do when a patient does not
nicely fit into one subgroup. If a patient does not meet or meets the criteria for multiple
subgroups, how is the patient treated? No evidence exists on the relative frequency with
which patients with PFPS fall into each of these proposed subgroups and whether these
subgroups are mutually exclusive.

The clinical classification systems reported in literature only address physical impairments.
Psychosocial factors have also been identified as important when treating patients with PFPS.
In a study by Piva et al. fear avoidance beliefs were the strongest predictor of outcomes for
function and pain. Mental health status on the Medical Outcomes Short Form-36 is correlated
with severity of patellofemoral symptoms in athletes. The results of these studies highlight
the necessity of addressing psychosocial factors when treating PFPS.

Therefore, the authors have designed a new classification system (PFPS algorithm) for
subgrouping patients based on the patient's clinical presentation. There are four subgroups
in the new PFPS algorithm: Fear-Avoidance, Flexibility, Functional Malalignment, and
Strengthening with function progression. The criteria and intervention of each subgroup is
addressed sequentially over the episode of care. This classification system aims to address
problems encountered if individuals meet the criteria for multiple subgroups. There is also a
psychosocial component to address the needs of individuals with activity avoidance. The PFPS
algorithm is goal-based, where meeting the criteria to pass through each subgroup is the
focus of the treatment. Clinicians can provide whichever physical therapy intervention that
allows an individual patient to meet the criteria of each subgroup. Interventions used in the
PFPS algorithm are based on best available evidence, clinician's experience, and the
patient's individual response to the intervention.

A pilot study assessing the feasibility of a full study assessing this algorithm and it
effectiveness was performed previously by the study investigators (IRB13-00749). The primary
aims of this pilot study were met. The therapists and clinic personnel successfully worked
together to carry out all treatments required to conduct a future full scale randomized
controlled trial. The ordered treatment approach used in the PFPS algorithm, addressing soft
tissue tightness, altered lower extremity kinematics, neuromuscular deficits and psychosocial
factors in a sequential manor, resulting in clinically significant improvements in Anterior
Knee Pain Scale and Global Rating of Change scores. With minor changes to the protocol and
outcome measures used, a full randomized controlled trial assessing the effectiveness of the
PFPS algorithm was deemed feasible.

The primary objective of this study is to assess the efficacy of using a sequential treatment
approach to treat patellofemoral pain syndrome.

Patient will be randomized into one of two treatment groups; either the PFPS algorithm or the
control group which is an impairment based approach.

Impairment Based Approach:

The control group will be an impairment based approach with treatment focusing on impairments
found during evaluation in the lower quarter. The evaluation of the lower quarter will assess
motion, flexibility, strength and body mechanics. The joints of the lower quarter include the
lumbar spine, hip, knee, ankle and foot. Specific attention will be paid to quadriceps and
hip strength, hip and knee flexibility, and squatting, jumping, walking and running
mechanics. Treatment will consist of 2 visits per week for 6 weeks. Treatments will last for
45-60 minutes. Exercises will be given for the patient to perform at home at the therapist
discretion. Interventions will be individualized to the patient and will be at the
therapist's discretion. Therapists can use treatments including but not limited to: exercise,
manual therapy, taping and bracing, orthotics, modalities, and education. Home exercises will
be given the therapist discretion consistent with standard care.

PFPS treatment algorithm:

The PFPS treatment algorithm is a objective goal driven treatment program. Treatment is at
the therapist discretion with the objective to meet the requirements for each subgroup.
Evidence from literature guides treatment to best meet these goals.

The first group within the classification system is Fear Avoidance, as research has shown
that a change in fear-avoidance beliefs about physical activity is one of the best predictors
for improved functional outcome.

The second group is Flexibility. This is the second group in the system because research
shows that patients with decreased flexibility are unable to properly perform functional
malalignment test. Also quadriceps length and gastrocnemius/soleus lengths are strongly
associated with PFPS.

The third group is Functional Malalignment. This group assesses the patient's form with
functional tasks. If the patient demonstrates impaired mechanics, time is spent with
strengthening and motor control so that the patient will be able to strengthen and return to
full function with proper technique.

The final group is Strengthening/Return to Function. This group will work strengthening of
the lower quarter muscles with particular attention to the quadriceps, hip abductor and
external rotators. This is also the time to progress the patient back to sport or functional
activity.

-Fear Avoidance Belief Questionnaire (A score of 15 or greater on this questionnaire results
in being give a PFPS fear avoidance booklet and treatment using a Cognitive Behavioral
emphasis)

Primary Muscle Flexibility Requirements (Not meeting 1 of these flexibility measures results
being placed into the flexibility subgroup)

- Quadriceps ≥ 130 degrees

- Gastrocnemius ≥ 12 degrees

- Soleus ≥ 20 degrees

- Weight Bearing Dorsiflexion ≥ 48 degrees

Secondary Muscle Flexibility (Having tightness in at least 3 of the following tests results
in being placed into the flexibility subgroup)

- Thomas test

- Ober's Test

- Hamstring Straight Leg Raise ≥ 80 degrees

- Adductor Flexibility

Functional Malalignment (Score of great than 1 results in being placed into functional
malalignment subgroup)

- Lateral Step Down test

- Single Leg Squat test

Strengthening/Functional Progression (A limb symmetry index score of >=90% for each of these
test is used to determine adequate LE strength and function)

- Single Hop Test

- Triple Hop Test

- Crossover Hop for Distance test

- Timed Step Down test

Inclusion Criteria:

-Clinical Diagnosis of Patellofemoral Pain Syndrome

Exclusion Criteria:

- Tenderness to palpation of patellar tendon, inferior pole of patella, or tibial
tubercle as primary complaint

- Patient is pregnant or nursing

- Patient has other current lower extremity injuries

- History of patellar subluxation or dislocations

- History of knee surgery

- Inability to follow directions
We found this trial at
4
sites
New Albany, Ohio 43054
Phone: 614-685-4348
?
mi
from
New Albany, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
Principal Investigator: Mitchell C Selhorst, DPT
Phone: 614-355-9764
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dublin, OH
Click here to add this to my saved trials
?
mi
from
Westerville, OH
Click here to add this to my saved trials