Clinical trial NCT01767246: The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome
Official title: The Evaluation of a Novel Treatment Algorithm for Patients With Patellofemoral Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Syndrome
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who are diagnosed with Patellofemoral Pain Syndrome (PFS) and present to our clinic will be offered the opportunity to participate in the study. If they consent to be in this study they will randomized into 2 treatment groups. The experimental treatment group will be treated according to the novel PFS treatment algorithm. The control group will receive treatment that would be considered standard physical therapy care. To apply standard physical therapy care in a standardized manner the investigators are using a multimodal treatment approach that has been previously shown by Lowry to be beneficial in the treatment of PFS. Both groups of subjects will be seen 2 times per week for a maximum of 12 visits. Patients can be discharged early if they no longer report pain or impaired function on the Anterior Knee Pain scale.

The purpose of this study is to see if patients with patellofemoral pain syndrome treated with the experimental Patellofemoral treatment algorithm experience significant improvements in function, pain and the number of treatment sessions compared with a previously researched multimodal approach to the treatment of patellofemoral pain.

The secondary objective of this study is to examine results to determine if a full randomized controlled clinical trial of the PFS algorithm is justified.

The investigators hypothesize that utilization of the Patellofemoral syndrome treatment algorithm with evaluation and treatment of patients diagnosed with PFS will lead to significant improvements in function, pain and the number of treatment sessions when compared to previously researched treatment of PFS.

Detailed description: Patients referred to for physical therapy with the diagnosis of Patellofemoral Pain Syndrome will be offered the opportunity to participate in the study. After explaining the study and answering any patient or parent questions, informed consent will be obtained for those individuals wishing to participate. The participants will be screened to see if they meet the inclusion criteria, and will be randomly assigned to either evaluation and treatment using the novel PFS treatment algorithm(experimental group) or evaluation and treatment using the multimodal approach to PFS. The evaluating therapist will take all measurements and perform treatments with the patients, and cannot be blinded to group allocation. The patient will not be made aware of if they are in the experimental or control group, but cannot be blinded to the treatment that they receive.

Multimodal approach to PFS: Patients randomized to the control treatment group will be treated in a manner consistent with a treatment approach previously described in literature that has been found effective in treating Patellofemoral Syndrome.

Multimodal PFS Evaluation

Postural Exam

* Lower Extremity (LE) Alignment
* Pelvic Rotation
* Navicular Drop

Neurodynamic Testing

* Straight Leg Raise (SLR) Muscle Flexibility
* 90/90 Hamstring (-20 degrees considered positive)
* Quadriceps length (Elys test)
* Standing gastrocnemius length
* Prone Piriformis length
* Supine Modified Thomas Test
* Ober's Test

AROM/PROM

* Hip
* Knee
* Great Toe Dorsiflexion (DF)
* Ankle DF
* Calcaneal/forefoot Valgus

Manual Muscle Testing (MMT) (as described by kendall)

* Gluteus maximus
* Gluteus Medius
* Quadriceps
* Hamstrings
* Hip Internal Rotation (IR)
* Hip External Rotation (ER)

Accessory Motions (to find restricted motion, or pain. Used to guide manual treatment)

* Posterior Anterior (PA) glides of the Lumbar Spine
* Hip
* Patella
* Tibiofemoral joints

Abdominal Recruitment -Palpated Abdominal Drawing-in maneuver (in hook lying position)

Special Tests

-Patellar Compression Test

Functional Tests

* Squat
* Step down test (Forward off 8 inch step)

Treatment using Multimodal Approach

Manual Therapy prior to Exercise

* Lumbopelvic thrust (Used if greater than 15 degrees prone hip IR noticed between sides. Up to 2 manipulations per side for 2 treatments.)
* Caudal hip non-thrust manipulations (Used if restriction noticed with accessory motion or pain with hip Range of Motion (ROM) at the start of session.)
* Patellar mobilizations (Inferior patellar joint mobilization used for -patellar compression test. Otherwise used for limited motion.)
* Proximal Tibiofibular Manipulation (Used if restriction of motion noticed between sides, or if patient experiences pain with knee flexion.)

Treatment modalities -Patellar Taping (Patient taped for the first 3 weeks of therapy) McConnell Medial Patellar Taping is attempted if patient reports pain on functional step down test. Taping used as an intervention if patients reports decreased pain of at least 2/10 with functional step down test after taping

Orthotics -Patient is fitted for and issued orthotics if a \>3mm drop with navicular drop test noted

Non Weight Bearing Exercise (Patient to be able to perform Non Weight Bearing (WB) exercises properly before progressing to WB)

* Abdominal isometric bracing in hook lying
* Abdominal bracing with heel slide
* Abdominal bracing with bent knee lifts
* Abdominal bracing with straight-leg raise
* Bridging (Patient in hook lying and asked to perform abdominal bracing, while lifting gluteal muscles from the table)
* Side-lying clamshells (Patient is sidelying, with hip and knees flexed to 45 degrees.)
* Quadruped Upper Extremity and LE lifts (Patient in quadruped and asked to perform abdominal bracing.)
* Quadruped Hip abduction (Patient in quadruped and asked to perform abdominal bracing)
* Quadruped Hip extension (Patient in quadruped and asked to perform abdominal bracing)

Weight Bearing Exercises (Must be able to complete 2 sets of 10 without substitution of non WB exercises)

* Double Leg Press ( Total gym/Shuttle)
* Single Leg Press ( Total gym/Shuttle)
* Eccentric Step-Downs (Forward Use a 4inch step)
* Eccentric Step-Downs (Lateral Use a 4inch step)
* Hip abduction sidestepping (Knees and hips slights flexed with theraband at ankles)
* Squats
* Lunge
* Clock Balance and Reach (functional star)

Stretches 3 sets of 30 second holds (only to be performed if tightness is found)

* Supine piriformis stretch
* Supine Gluteus figure-four stretch
* Standing hamstring stretch
* Standing quad stretch
* Standing Iliotibial band Stretch
* Standing gastrocnemius stretch

PFS treatment algorithm:

The PFS 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 PFS.

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 Questionaire (A score of 15 or greater on this questionaire results in being give a PFS 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
* WB DF ≥ 50 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 SLR ≥ 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

Eligibility criteria: Inclusion Criteria:

-Diagnosis of Patellofemoral 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

Primary outcomes:
measure: Change in Anterior Knee Pain Scale
timeFrame: 2 times per week for up to 6 weeks
Secondary outcomes:
measure: Global Rating of Change Scale (GROC)
timeFrame: every visit after the initial assessment (2 times per week for up to 6 weeks)
measure: Number of treatment session
timeFrame: at subject's discharge from study (expected average to be 6 weeks)
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: at every visit (2 times per week for up to 6 weeks)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital Sports and Orthopedic PT East Broad St location
state: Ohio
city: Westerville
country: United States
facility: Nationwide Children's Hospital Sports and Orthopedic PT Westerville location
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Mitchell C Selhorst, MPT
role: PRINCIPAL_INVESTIGATOR
References:
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