Clinical trial NCT04692727: Taping and Patellar Maltraction in PFPS Patients
Official title: The Effectiveness of Different Taping Methods Applied in Addition to Exercise in Patients With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: PFPS
Magnetic Resonance Imaging
McConnell
femoral rotation
taping
malalignment
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized controlled study:Three parallel treatment groups; the control group received only exercise therapy, while the other two groups received two different taping treatments in addition to exercise therapy.
Primary purpose: TREATMENT

Brief summary: Patellofemoral Pain Syndrome(PFPS) treatment is basically conservative, but there is no general consensus on the most appropriate therapeutic approach. The aim of this study was to examine the misalignment of the patellofemoral joint with MRI and compare the effectiveness of McConnell patellar taping and femoral lateral rotational taping techniques applied to exercise function on pain, patellar maltraction, functional status, balance and quality of life in patients with PFPS.

Detailed description: This is a single blinded randomized controlled trial, will be conducted at Ankara Yıldırım Beyazıt UniversityYenimahalle Education and Research Hospital. Evaluations regarding the parameters and inclusion criteria at the stage of diagnosis will be carried out by the Specialist Physician, exercise therapy and taping practices by the Specialist Physiotherapist, and the MRI measurements by the Specialist Radiologist. Fixed probability stratified randomization method will be preferred in order to ensure proportional gender distribution in the formation of groups and participants will be divided into 3 groups. An exercise program that includes stretching, strengthening and balance exercises accompanied by physiotherapist in the clinic will be applied to all individuals participating in the study for 2 times/week X 6 weeks (12 sessions). Only the exercise program will be applied to the first group. To the second group; McConnell patellar taping technique will be applied using rigid tape(Leukotape® P Rigid Strapping Tape, 38 mm X 10 m, USA) in addition to the exercise program in each session.To the third group; femoral lateral rotation taping technique will be applied using rigid tape in addition to the exercise program. Patients' patellar maltraction, pain function, balance, and quality of life will be assessed before and after treatment with MRI and clinical testing.

Eligibility criteria: Inclusion Criteria:

* Presence of anterior knee pain lasting more than 6 weeks
* Anterior or retropatellar knee pain is present in at least two activities (stair descending, stair climbing, squatting, running, jumping, sitting for a long time
* Presence of malalignment of patellofemoral joint in MRI examination \[Bisect offset index (BOİ) ≥57 and / or patellar tilt angle (PTA) ≥15\]

Exclusion Criteria:

* presence of knee trauma history and/or previous knee surgery
* presence limitation in knee joint range of motion
* presence of meniscopathy or lesion in knee ligaments
* presence of patellar subluxation or dislocation
* presence of a neuromuscular (upper or lower motor neuron lesions), cardiovascular or rheumatological disease
* pregnancy status
* presence of MRI contraindications

Primary outcomes:
measure: Change in Bisect offset index (BOI)
timeFrame: Change from baseline BOI at 6 weeks
measure: Change in Patellar tilt angle (PTA)
timeFrame: Change from baseline PTA at 6 weeks
measure: Change in Lateral patellofemoral angle (LPFA)
timeFrame: Change from baseline LPFA at 6 weeks
measure: Change in Lateral patellar displacement (LPD)
timeFrame: Change from baseline LPD at 6 weeks
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Y balance test (YBT)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Kujala Patellofemoral Score (KPS)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Q angle
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Nottingham Health Profile (NHP)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Timed up and go test (TUG)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Stair climb test (SCT)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Genu Valgum/Varum
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Patella type
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Sulcus angle (SA)
timeFrame: Just before the treatment and at the end of 6-week treatment.
measure: Trochlear depth (TD)
timeFrame: Just before the treatment and at the end of 6-week treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Ertuğrul Demirdel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laugharne E, Bali N, Purushothamdas S, Almallah F, Kundra R. Variability of Measurement of Patellofemoral Indices with Knee Flexion and Quadriceps Contraction: An MRI-Based Anatomical Study. Knee Surg Relat Res. 2016 Dec 1;28(4):297-301. doi: 10.5792/ksrr.16.032.
citation: Nakagawa TH, Muniz TB, Baldon Rde M, Dias Maciel C, de Menezes Reiff RB, Serrao FV. The effect of additional strengthening of hip abductor and lateral rotator muscles in patellofemoral pain syndrome: a randomized controlled pilot study. Clin Rehabil. 2008 Dec;22(12):1051-60. doi: 10.1177/0269215508095357.
citation: Song CY, Huang HY, Chen SC, Lin JJ, Chang AH. Effects of femoral rotational taping on pain, lower extremity kinematics, and muscle activation in female patients with patellofemoral pain. J Sci Med Sport. 2015 Jul;18(4):388-93. doi: 10.1016/j.jsams.2014.07.009. Epub 2014 Jul 24.
citation: Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
citation: Callaghan MJ, Guney H, Reeves ND, Bailey D, Doslikova K, Maganaris CN, Hodgson R, Felson DT. A knee brace alters patella position in patellofemoral osteoarthritis: a study using weight bearing magnetic resonance imaging. Osteoarthritis Cartilage. 2016 Dec;24(12):2055-2060. doi: 10.1016/j.joca.2016.07.003. Epub 2016 Jul 16.
citation: Callaghan MJ, Selfe J. Patellar taping for patellofemoral pain syndrome in adults. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD006717. doi: 10.1002/14651858.CD006717.pub2.