Evaluation of a Treatment Algorithm for Patients With Patellofemoral Pain Syndrome

NCT02461095 | Completed

• 1 other identifier: IRB15-00311
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Anterior Knee Pain Scale

  Assessment of change of the Anterior Knee Pain Scale (AKPS). The AKPS is a self-reported 13 item questionnaire with discrete categories related to various levels of current knee function. Categories within each item are weighted, and responses are summed to provide an overall score of 0-100, with 100 representing no disability. The Anterior Knee Pain Scale is found to be valid and reliable in patients from 12-50 years of age presenting with anterior knee pain with a test-retest reliability of .95 (Watson, 2005). A change of 10 points represent the minimal clinical difference (Crossley, 2004).

  Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months

Secondary Outcomes (2)

• Change in Numeric Pain Rating Scale

  Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months

• Global Rating of Change Scale (GROC)

  Baseline, 3 weeks (18-24 days post-evaluation), 6 weeks (39-46 days post-evaluation), 3 months and 6 months

Study Arms (2)

Impairment based approach

ACTIVE COMPARATOR

The intervention will address the patients impairments found during evaluation. Treatment will based on the Physical therapist evaluation and will be individualized to each patient.

Other: Impairment based approach

PFPS algorithm

EXPERIMENTAL

The Patellofemoral Syndrome algorithm is designed to determine what deficits a patient may have and addressing these sequentially. This subgrouping first assesses a patient fear avoidance beliefs, flexibility, body mechanics, and then strength and functional ability. The reason for sequential treatment is that there is evidence that without adequate flexibility a patient will be unable to perform exercises with proper body mechanics, and without proper mechanics strengthening and functional activity can cause increased stress on the patellofemoral joint. Progression through each specific subgroup is based on objective goals. Once the patient has met these goals they are progressed to the next treatment subgroup until discharge.

Other: PFPS Algorithm approach

Interventions

Impairment based approach OTHER

This intervention will consist of exercise, mechanics training, education, manual therapy and modalities. The treatment will address the impairments found during the evaluation. This approach is a typical individualized physical therapy treatment approach.

Impairment based approach

PFPS Algorithm approach OTHER

Physical Therapy treatment for Patellofemoral Pain Syndrome based upon a treatment algorithm that addresses patients: fear avoidance beliefs, flexibility, body mechanics, and strength. The exercises and treatments are individualized to each patient with the goals of low fear avoidance beliefs, flexibility, body mechanics, and strength and are performed in a sequential manner

PFPS algorithm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Diagnosis of Patellofemoral Pain Syndrome

You may not qualify if:

• 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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (4)

Nationwide Children's Hospital Sports and Ortho PT East Broad

Columbus, Ohio, 43213, United States

Location

Nationwide Children's Hospital Sports and Ortho PT Dublin

Dublin, Ohio, 43017, United States

Location

Nationwide Children's Hospital Sports and Ortho PT New Albany

New Albany, Ohio, 43054, United States

Location

Nationwide Children's Hospital Sports and Orthopedic PT Westerville location

Westerville, Ohio, 43082, United States

Location

Related Publications (8)

• Powers CM, Bolgla LA, Callaghan MJ, Collins N, Sheehan FT. Patellofemoral pain: proximal, distal, and local factors, 2nd International Research Retreat. J Orthop Sports Phys Ther. 2012 Jun;42(6):A1-54. doi: 10.2519/jospt.2012.0301. Epub 2012 Jun 1.

  PMID: 22660660 BACKGROUND

• Piva SR, Fitzgerald GK, Wisniewski S, Delitto A. Predictors of pain and function outcome after rehabilitation in patients with patellofemoral pain syndrome. J Rehabil Med. 2009 Jul;41(8):604-12. doi: 10.2340/16501977-0372.

  PMID: 19565153 BACKGROUND

• Bolgla LA, Boling MC. An update for the conservative management of patellofemoral pain syndrome: a systematic review of the literature from 2000 to 2010. Int J Sports Phys Ther. 2011 Jun;6(2):112-25.

  PMID: 21713229 BACKGROUND

• Wang YC, Hart DL, Stratford PW, Mioduski JE. Baseline dependency of minimal clinically important improvement. Phys Ther. 2011 May;91(5):675-88. doi: 10.2522/ptj.20100229. Epub 2011 Mar 3.

  PMID: 21372203 BACKGROUND

• Piva SR, Gil AB, Moore CG, Fitzgerald GK. Responsiveness of the activities of daily living scale of the knee outcome survey and numeric pain rating scale in patients with patellofemoral pain. J Rehabil Med. 2009 Feb;41(3):129-35. doi: 10.2340/16501977-0295.

  PMID: 19229444 BACKGROUND

• Watson CJ, Propps M, Ratner J, Zeigler DL, Horton P, Smith SS. Reliability and responsiveness of the lower extremity functional scale and the anterior knee pain scale in patients with anterior knee pain. J Orthop Sports Phys Ther. 2005 Mar;35(3):136-46. doi: 10.2519/jospt.2005.35.3.136.

  PMID: 15839307 BACKGROUND

• Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0.

  PMID: 15129407 BACKGROUND

• Selhorst M, Rice W, Degenhart T, Jackowski M, Tatman M. Evaluation of a treatment algorithm for patients with patellofemoral pain syndrome: a pilot study. Int J Sports Phys Ther. 2015 Apr;10(2):178-88.

  PMID: 25883866 RESULT

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Mitchell Selhorst, DPT

  Nationwide Childrens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist/Research Coordinator

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 3, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

US (4)