Clinical trial NCT03985254: Do Power Exercises Result in Superior Benefits for People With Patellofemoral Pain?
Official title: Does Adding Power Exercises to Muscle Force Training Result in Superior Benefits for Patellofemoral Pain People? Randomized and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patellofemoral pain (PFP) is one of the most common forms of knee pain and has a negative impact on the level of physical activity and quality of life of patients. Although strengthening of the hip and knee muscles has good clinical effects in the treatment of PFP, most exercise protocols do not follow the American College of Sports Medicine (ACSM) guidelines and are not clearly described, making it difficult to apply them in practice clinical and research. In addition, recent studies have shown that these patients also have a power deficit of these muscles. However, it is not known whether the addition of power exercises to a muscle strengthening program would result in superior benefits, especially in relation to pain and physical function. Therefore, the objective of this study is to verify if the improvement in pain intensity, physical function, kinesiophobia, self perception of improvement, quality of life and muscle function variables after a training program of strength and muscular power is superior to that observed in an isolated muscle strength training. This study will be randomized and controlled, developed with individuals with DPF, allocated in one of two groups: Strength Training Group (STG) and Strength and Power Training Group (SPTG). The primary outcomes will be intensity of pain and physical function, while the secondary outcomes will be kinesiophobia; self perception of improvement; quality of life; the peak of isometric abductor and hip extensor torque, and knee extensor; and the rate of development of torque of the abductors and extensors of hip, and extensors of knee at 30% and 90% of maximum isometric torque. Participants in both groups will be evaluated before the intervention (pre), after the end of the intervention (post) and three, six and twelve months after the intervention. Data analysis will follow the intention-to-treat principle. To compare the groups at different times (pre, post and after three, six and twelve months of the intervention) will be used two-way analysis of variance (GROUP X MOMENT) with mixed model, with Bonferroni post hoc to identify specific differences. The significance level will be 0.05.


Eligibility criteria: Inclusion Criteria:

* men and women with bilateral or unilateral patellofemoral pain

Exclusion Criteria:

* history of knee surgery
* history of hip or lumbar spine injury or pain
* patellar instability
* pain on palpation of the patellar tendon, iliotibial band, Hoffa fat, goose paw tendons or knee joint line
* signs or symptoms of meniscal or knee ligament injuries
* presence of Osgood-Schlatter syndrome or Sinding-Larsen-Johansson syndrome
* any vestibular, neurological or musculoskeletal alterations that interfere or contraindicate the procedures of this study

Primary outcomes:
measure: Change from baseline pain Intensity at 12 weeks
timeFrame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)
measure: Change from baseline physical function at 12 weeks
timeFrame: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)
Secondary outcomes:
measure: Kinesiophobia
timeFrame: Pre (baseline) treatment and post treatment (12 weeks)
measure: Self-perception of improvement
timeFrame: Pre (baseline) treatment and post treatment (12 weeks)
measure: Change Quality of Life
timeFrame: Pre (baseline) treatment and post treatment (12 weeks)
measure: Maximal Isometric Torque and Rate of Force Development (RFD)
timeFrame: Pre (baseline) treatment and post treatment (12 weeks)
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Gabriela Souza de Vasconcelos
state: São Paulo
Study officials:
References:
citation: de Vasconcelos GS, Nunes GS, Barton CJ, Munhoz RF, da Silva MECB, Pisani GK, Luz BC, Serrao FV. Adding muscle power exercises to a strength training program for people with patellofemoral pain: protocol of a randomized controlled trial. Trials. 2021 Nov 6;22(1):777. doi: 10.1186/s13063-021-05748-x.