Clinical trial NCT01438762: Early Intervention for Adolescents With Patellofemoral Pain Syndrome
Official title: Early Intervention for Adolescents With Patellofemoral Pain Syndrome - a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Anterior Knee Pain
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Aarhus University Hospital
First posted: 2011-09-22
Enrollment: 102
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Self-reported, unspecific knee pain is highly prevalent among adolescents. A large proportion of the unspecific knee pain can be attributed to Patellofemoral Pain Syndrome (PFPS). There are a number of treatment options for PFPS. Physical therapy has been advocated as one of the cornerstones in rehabilitation of patients with PFPS. Twenty-five years ago, McConnell proposed a multimodal approach that combined several treatment options. The regimen included retraining of the vastus medialis oblique muscle through functional weight bearing activities. This exercise is combined with patellar taping, patellar mobilization, and stretching to improve patellar tracking, reduce pain, and enhance vastus medialis oblique muscle activation. Short term results (\<12 months) indicates that multimodal physiotherapy is more effective than placebo treatment.

While treatment for PFPS may be successful for the short-term, long-term results are less promising. A recent review covering the long term prognosis for patients diagnosed with PFPS, reported that only 1/3 of those diagnosed with PFPS and treated conservatively were pain free 12 months after diagnosis. Further ¼ stopped participating in sports because of knee pain.

Predictors of long term outcome (\>52weeks) indicate that a long symptom duration, higher age and greater severity at baseline are associated to poorer outcome after treatment. These prognostic factors suggest that an early initiation of treatment might lead to a better long-term prognosis. The purpose of this study is to examine the short and long-term effectiveness of multi-modal physiotherapy compared to standard wait-and-see treatment applied at a very early state of disease among adolescents. The investigators hypothesized a significantly larger proportion of completely recovered patients at three-month follow-up in the interventions group compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Age 15-19 years
* Insidious onset of anterior knee or retropatellar pain of greater than six weeks' duration
* Provoked by at least two of prolonged sitting or kneeling, squatting, running, hopping, or stair walking
* Tenderness on palpation of the patella, or pain with step down or double leg squat
* Worst pain over the previous week of at least 30 mm on a 100 mm visual analogue scale.

Exclusion criteria:

* Concomitant injury or pain from the hip, lumbar spine, or other knee structures
* Previous knee surgery
* Patellofemoral instability
* Knee joint effusion
* Use of physiotherapy for treating knee pain within the previous year
* Use of weekly use anti-inflammatory drugs.

Primary outcomes:
measure: Change in perception of recovery after 12 months measured on a 7-point likert scale ranging from "completely recovered" to "worse than ever".
timeFrame: Baseline, 3, 6, 12 and 24months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline, 3, 6, 12 and 24months
measure: EQ5D
timeFrame: Baseline, 3, 6, 12 and 24months
measure: Neuromuscular function
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Surgery Research Unit, Aalborg Hospital
Study officials:
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Michael S Rathleff
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
name: Ewa M Roos, Ph.d
role: STUDY_CHAIR
affiliation: Aalborg University Hospital
name: Jens L Olesen, MD, Ph.d
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, MD
role: STUDY_CHAIR
References:
citation: Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Exercise during school hours when added to patient education improves outcome for 2 years in adolescent patellofemoral pain: a cluster randomised trial. Br J Sports Med. 2015 Mar;49(6):406-12. doi: 10.1136/bjsports-2014-093929. Epub 2014 Nov 11.
citation: Rathleff MS, Roos EM, Olesen JL, Rasmussen S, Arendt-Nielsen L. Lower mechanical pressure pain thresholds in female adolescents with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2013 Jun;43(6):414-21. doi: 10.2519/jospt.2013.4383. Epub 2013 Mar 18.
citation: Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Early intervention for adolescents with patellofemoral pain syndrome--a pragmatic cluster randomised controlled trial. BMC Musculoskelet Disord. 2012 Jan 27;13:9. doi: 10.1186/1471-2474-13-9.