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Knee arthroscopy and exercise versus exercise only in relieving pain and disability in patients with chronic patellofemoral pain syndrome (PFPS). A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41800323
Enrollment
56
Registered
2006-01-10
Start date
2003-02-12
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic (> 6 months before inclusion) patellofemoral pain syndrome. Musculoskeletal Diseases Patellofemoral pain syndrome

Interventions

The aim of this study is to compare the value of diagnostic + operative arthroscopy with home exercise program (arthroscopy group) versus home exercise program only (control group) on subjects with ch

Sponsors

Social Insurance Institution of Finland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In the first phase, orthopaedists select consecutive female or male patients who are admitted to the hospital policlinic of either ORTON Orthopaedic Hospital, Helsinki or one of the orthopaedic policlinics of the Hospital District of Helsinki and Uusimaa and who amongst them fulfil the following inclusion criteria: 1. Subjects that are 18 to 40 years of age female or male and have a characteristic history and symptoms of PFPS for at least six months 2. They have patellofemoral pain during physical activities, such as jumping, running, squatting, and going up or down stairs; patellofemoral pain when the knee is kept in flexion for a prolonged period, with relief on extension; and possibly, patellar snapping, pseudo-locking, giving-way, stiffness, or periodic effusions in conjunction with physical activity. Subjects with patellar subluxation but not with a history of patellar dislocation, are included.

Exclusion criteria

Exclusion criteria: 1. Subjects with disabling general illnesses, report knee ligamentous or meniscal injuries, previous knee surgery, physician diagnosed knee osteoarthritis or a history of patellar dislocation 2. Subjects who have been in physical therapy for PFPS within the previous 4 weeks 3. Subjects who are pregnant 4. Subjects who are competitive athletes and therefore may have pain syndrome related to extreme loading and perhaps not be willing to follow the treatment protocols 5. Subjects with antero-posterior or medio-lateral instability in manual instability measurement or with knee problems other than PFPS (such as jumper's knee or knee meniscal injury) based on clinical evaluation 6. Subjects with knee osteoarthritis, osteochondritis dissecans, loose bodies in the patellofemoral and tibiofemoral joints, or with knee problems other than PFPS are excluded based on the findings in the knee x-ray examination

Design outcomes

Primary

MeasureTime frame
Kujala score, which is a 13-item questionnaire with discrete categories related to various levels of knee function. Categories within each item are weighted, and responses are summed to provide an overall index in which 100 represents no disability. Among other things, the questionnaire evaluates pain or disability related to the loading of the patellofemoral joint during sitting, walking, running, jumping, and stair climbing. (Kujala et al. Scoring of patellofemoral disorders. Arthroscopy 1993;9:159-63). Many authors who have used this score later have termed it as 'the Anterior Knee Pain Scale (AKPS)'. Main follow-up time-point is 37 weeks after randomization (= 6 months after the exercise training period started three weeks after randomization in both treatment groups). Other time-points when the main outcome is measured are before the randomization, 11 weeks after randomization (immediately after the 8 week home training period = 10 weeks after arthroscopy), 63 week follow-up (= 12 months after the training period), and 115 week follow-up (= 24 months after the training period).

Secondary

MeasureTime frame
Three different 10 cm visual analog scales (VASs) to assess activity related pains. Participants assess maximum pain in the previous two days during ascending stairs, descending stairs, and standing up, where 0 = no pain and 100 = extremely intense pain. Also, a global rating of change (overall assessment) is evaluated with an additional 6-point scale: 1 = asymptomatic knee to 6 = marked worsening than before treatment. The subjects also keep a diary related to possible adverse effects and use of drugs as well as on other treatments not related to the study protocol. Adverse effects and a cost-effectiveness analysis will be reported.

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026