The purpose of this study is to evaluate the effect on the outcome measures function, pain, and strength of manual therapy of the lumbar vertebral spine, the SIG and hip joint in patients with the PFPS comparing with the effect of physical therapy…
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Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The AKPS questionnaire is used as the primary outcome measure The AKPS is a
questionnaire with 13 items that together give a maximum of 100 points which
lower scores indicates an increasing degree of limitations. (Kujala 1993) The
AKPS has high test-retest reliability and good internal consistency (ICC =
0.95) (Horton 2005) The Dutch translation used in this study is similar to the
original English questionnaire. The standard error of measurement (SEM) here is
0.78 and the smallest detectable change is (SDC) ± 11.01. (Ummels 2015) This is
a scale from 0 mm (no pain) to 100 mm (worst possible pain).
Secondary outcome
As secondary outcomes, the VAS and Biodex are used. The VAS has a good internal
consistency, test-retest reliability and responsiveness (Lara Muñoz 2005) The
VAS has a minimal Important Change (MIC) of 30% or 20 mm from the starting
value. (Ostelo 2008). The VAS questionnaire is used to identify the minimum,
maximum and average pain. VAS for average and maximum pain and AKPS are the
most reliable and responsive outcome measures in the treatment of PFPS. The
AKPS has a moderate correlation with the VAS (r = 0.74) (Crossley 2004). So, it
does not always have to give an improvement in function when there is an
improvement of the pain.
The Biodex has an acceptable reliability and validity (Drouin 2001 Valovich
2001) It gives reliable results for torque, position and angular velocity on
repeat testing on the same day and on different days. The validity of the
isometric torque and position measurements is acceptable for clinical and
research purposes (Drouin 2003).
Background summary
The Patellofemoral Pain Syndrome (PFPS) is a condition characterized by
retropatellar and / or peripatellar pain. Pain occurs on or after activities
in which the knee is loaded (walking, running, jumping, climbing stairs, squats
and prolonged sitting. (Davis et al. 2010, Cook et al. 2010). the PFPS is one
of the most frequent knee injuries. Approximately 25% of all knee injuries is
diagnosed as the PFPS. (Fredericson et al. 2006)
The incidence of PFPS was 22/1000 person-years. Women are twice as likely to
develop the PFPS (Boling et al. 2010). Due to the large impact of the PFPS on
the daily function, the risk of knee osteoarthritis in later life (Thorstensson
2004, 2008) and its high prevalence, an effective treatment strategy is
important. The studies on the treatment of PFPS are numerous. However, there is
still no clear consensus on how to treat this condition.
For example, insoles regularly prescribed, but with varying results (Barton
2010). Also, therapy aimed at enhancing the strength of the quadriceps,
gluteaal- and calf muscles, whether or not combined with mobilization of the
patellofemoral joint, has shown to reduce pain and improve motor control
(Fucuda 2010 Kooiker 2014, Peters et al. 2013). However, this does not always
work well for each patient. The orthopedic surgeons of the Bergman Clinic
regularly sends patients to the authors to further chart the symptoms and for
treatment. These patients often already had one or more sections with or
without evidence-based targeted physiotherapy with moderate to completely no
effect. From clinical experience of the authors in a pilot of 45 patients with
PFPS and a case series of 14 patients (Nieuwenhuizen 2013) has shown that there
is a causal relationship between the PFPS and disorders in the thoracolumbar
spine and the hip joint. These disorders were found in the mobility of the
thoracolumbar junction (TLO) and / or connective tissue of the lumbar spine
(lumbar spine), the sacroiliac joint (SIG) and hip extension. Treatment through
manual therapy for these disorders gave a significant improvement in function
and pain of the knee
The positive experiences from the pilotstudy concerning the treatment of these
disorders, the researchers decide to use this as an intervention in this study.
Our hypothesis is that manual therapy will give better results in the treatment
of the patellofemoral pain syndrom than conventional treatment in terms of
pain, function, and strength.
Study objective
The purpose of this study is to evaluate the effect on the outcome measures
function, pain, and strength of manual therapy of the lumbar vertebral spine,
the SIG and hip joint in patients with the PFPS comparing with the effect of
physical therapy on these outcome measures with training the strength of the
hip and gluteal muscles in these patients.
Study design
The study is a randomized controlled trial with two intervention groups.
Intervention
One group gets the intervention with manual therapy and the other group
receives the intervention physiotherapy. After intake follows a treatment-free
period of 3 weeks. At the start of the treatment intervention pain, function
and strength will be measured as a baseline measurement. The intervention
manual therapy consists of 6 sessions of manual therapy with a frequency of
once a week focused on the disorders found in the lumbar spine, hip and SIG.
The physiotherapy intervention consists of strengthening the gluteal and
surrounding muscles of the knee such as the quadriceps and calf muscles coupled
with mobilization of patellofemoral joint with a frequency of once a week for
the duration of 6 weeks.
Study burden and risks
The load for the subjects is as follows:
- One time to physiotherapy department to subscribe for research participation
directly from the orthopedic surgeon
- subscribe online for taking surveys. These questionnaires are 4x times
conducted over a period of 15 weeks. This load equals the load of
questionnaires to patients in regular care. In addition, the VAS (min, max,
average) is conducted digitally once a week in the first three weeks.
- 3 times a test on the Biodex. This is a (maximum) strength test and lasts
about 10 minutes plus 15 minutes warming up.
- 6 times treatment physiotherapy or manual therapy in the clinic. The risk of
physical therapy treatment is negligible. There is no known evidence to the
authors that this treatment can cause harm. About the treatment manual therapy
can be said that the risk is very low. This is a frequently performed treatment
in the standard care. The literature indicates that the risk of manipulations
in the lumbar spine is very low. About the treatment physiotherapy and manual
therapy can be said that this is done with the knowledge of the most recent
evidence. Conducting the survey is justified because of the low risk and the
expected significant improvement of both therapies.
Jan cornelisz maylaan 6
utrecht 3526 GV
NL
Jan cornelisz maylaan 6
utrecht 3526 GV
NL
Listed location countries
Age
Inclusion criteria
The clinical diagnosis of PFPS was formed if the subject had a self complaint of atraumatic uni- or bilateral anterior knee pain that was aggravated with at least two of the following activities: a positive patella compression test, squatting, prolonged sitting, and ascending of descending the stairs.
Exclusion criteria
Exclusion criteria included pain less than 3 months, prior knee or spine surgery, severe lumbosacral nerve root compression signs. Other exclusion criteria included clinical signs of ligamentous instability or suspected meniscal injury, patellar tendinopathy, (sub)luxations of the patella, pregnancy, osteoporosis, neurologic disorders. MRI, xray and/ or echo will be used for exclusion.
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 |
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CCMO | NL57207.096.16 |