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An early physical therapy program for anterior knee pain

Effectiveness of early physical therapy compared to delayed physical therapy for patients with patellofemoral pain: a multicentre randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-57dgft9
Enrollment
Unknown
Registered
2025-10-02
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Patellofemoral disorders

Interventions

This is a controlled superiority clinical trial with two arms, double-blind, and multicenter design. Experimental group: 76 males or females with recent-onset patellofemoral pain (4 to 12 weeks of pai
I02.233.332
E02.779.483

Sponsors

Universidade Estadual Paulista Julio de Mesquita Filho
Lead Sponsor
Faculdade de Ciências e Tecnologica da Universidade Estadual Paulista
Collaborator

Eligibility

Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Young adult males and females; aged 18-35 years old; with anterior knee pain when performing at least two functional activities; self-report recent- (4 to 12 weeks) or late-onset (more than 6 months) pain; insidious-onset pain in one or both knees; worst pain level in the last 4 weeks of at least 3 on a 0-10 numeric pain scale

Exclusion criteria

Exclusion criteria: Clinical evidence of any other knee disorder/condition; history of recent lower back or limb injury (less than 6 months); recent engagement to a physical therapy program (less than 1 month); history of knee or lower limb surgery; low back pain with leg pain; inability to read or understand english, portuguese, or french-speaking Belgian; presence of heart or neurological diseases

Design outcomes

Primary

MeasureTime frame
A reduction in the average pain intensity of at least 2 on a 0-10 numeric pain scale is expected immediately after the intervention in both groups. However, greater magnitude changes and effect sizes are anticipated for the early intervention group compared to the delayed one. Additionally, gains are expected to be maintained after 3, 6, and 12 months for those in the early intervention group, but not for those in the delayed intervention group.;An increase in the average self-reported function of at least 16 points on 'The Patellofemoral Pain and Osteoarthritis Subscale of the KOOS' is expected immediately after the intervention in both groups. However, greater magnitude changes and effect sizes are expected for the early intervention group compared to the delayed one. Additionally, gains are expected to be maintained after 3, 6, and 12 months for those in the early intervention group, but not for those in the delayed intervention group.

Secondary

MeasureTime frame
An improvement in self-reported recovery as assessed by the 'Global Rating of Change Scale (GROC)' is expected immediately after the intervention in both groups. However, larger magnitude improvements are expected for the early intervention group compared to the delayed one. Additionally, gains are expected to be maintained after 3, 6, and 12 months for those in the early intervention group, but not for those in the delayed intervention group.;A reduction in physical activity-related fear of movement, indicated by a decrease in the final score in the physical activity domain of the 'Fear Avoidance Belief Questionnaire (FABQ)', is expected immediately after the intervention in both groups. However, greater magnitude improvements and effect sizes are expected for the early intervention group compared to the delayed one. Additionally, gains are expected to be maintained after 3, 6, and 12 months for those in the early intervention group, but not for those in the delayed intervention group.;A reduction in kinesophobia, indicated by a decrease in the final score of the 'Tampa Scale of Kinesiophobia' questionnaire, is expected immediately after the intervention in both groups. However, greater magnitude improvements and effect sizes are expected for the early intervention group compared to the delayed one. Additionally, gains are expected to be maintained after 3, 6, and 12 months for those in the early intervention group, but not for those in the delayed intervention group.;A reduction in pain catastrophizing, indicated by a decrease in the final score of the 'Pain Catastrophizing Scale' questionnaire, is expected immediately after the intervention in both groups. However, greater magnitude improvements and effect sizes are expected for the early intervention group compared to the delayed one. Additionally, gains are expected to be maintained after 3, 6, and 12 months for those in the early intervention group, but not for those in the delayed intervention group.;A reduct

Countries

Belgium, Brazil, United States

Contacts

Public ContactTalita Vanderlei

Faculdade de Ciências e Tecnologica da Universidade Estadual Paulista

talita.marques@unesp.br+55 (18) 32295535

Outcome results

None listed

Source: REBEC (via WHO ICTRP)