The aim of this study is to determine the clinical effectiveness of custom-made insoles on the general pain severity of patients with PFPS after 12 weeks from baseline.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
General pain severity over the preceding week after 12 weeks from baseline,
measured on a numeric rating scale (NRS).
Secondary outcome
- experience of pain (using a NRS) and impairment (using a Likert scale) on
activities of daily living, on work/study and on sporting activities over the
preceding week
- self-reported recovery (using a Likert scale)
- functional disability (using the Anterior Knee Pain scale)
- participants pain experience (using two questionnaires: SCL-90 and POMS)
- satisfaction with the custom-made insoles based on comfort
Background summary
This study was designed after reviewing the literature on conservative therapy
for patellofemoral pain syndrome (PFPS) in athletes. It was concluded that
despite the wide prevalence and impact of PFPS there is a lack of high-quality
research for the conservative management of PFPS in athletes. Insoles seem to
play an important role in the general prevention and clinical management of
PFPS, but again this is not studied in athletes. We investigate the
effectiveness of insoles in athletes with patellofemoral pain on pain severity,
perceived impairment, perceived recovery and functional disability. If
custom-made insoles prove to be effective in athletes with patellofemoral pain
syndrome, this may be helpful for optimizing treatment of those suffering from
this condition.
Study objective
The aim of this study is to determine the clinical effectiveness of custom-made
insoles on the general pain severity of patients with PFPS after 12 weeks from
baseline.
Study design
The study involves a randomized controlled clinical trial with a 12-week
follow-up from baseline. It will have two treatment arms: a home-based exercise
program combined with custom-made insoles compared with a home-based exercise
program with flat insoles.
Intervention
80 participants will be randomly assigned to the treatment or placebo group.
Both groups will receive a home-based exercise program. In addition, the
treatment group receives custom-made insoles and the placebo group flat
insoles.
Study burden and risks
Participants have to come to Groningen one to four times, have to wear the
insoles as often as possible, and accomplish the home-based exercise program 5
days a week for 25 minutes. They also have to fill in a questionnaire three
times and keep up the logbook once a week, and will be called once. This study
involves no risks associated with participation. Patients have to wear insoles
that will fit their shoes comfortably as a primary goal to prevent wounds. The
home-based exercise program is easy to accomplish and there are no dangerous
exercises.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Age 18-40 years
- athletes sporting at least three hours a week pre-injury
- clinical diagnosis of patellofemoral pain syndrome: insidious onset of anterior or retropatellar knee pain lasting longer than six weeks and provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping/jumping, climbing stairs; tenderness upon palpation of the patella, and worst pain over the previous week of at least 3 out of 10 on a 10-point numerical rating scale.
Exclusion criteria
- A traumatic origin
- Concomitant injury or pain form the hip, lumbar spine, or other knee structures (like intra-articular pathology of the knee, Osgood Schlatter*s disease, bursitis and patellar tendinopathy)
- Previous knee surgery
- Patellofemoral instability
- Knee joint effusion
- Previous treatment with insoles or physiotherapy in the preceding 12 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41127.042.12 |
| Other | TC 3430 |