NCT03985254

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

June 10, 2019

Last Update Submit

August 26, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from baseline pain Intensity at 12 weeks

    Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating extremely intense pain. Participants will indicate their usual pain and their worst pain during the last week (CROSSLEY et al, 2004). The VAS scores will be computed by measuring the length of the line, in millimeters, from the left end (without pain) until the mark made by the participant.

    Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)

  • Change from baseline physical function at 12 weeks

    The Anterior Knee Pain Scale, a translated and validated Portuguese version (DA CUNHA et al, 2013), will be used to evaluate subjective symptoms, such as anterior knee pain and functional limitations related to PFP. The items assessed in the questionnaire are patellar subluxation, lameness, pain, walking, climbing stairs and remaining seated for prolonged time with knees flexed. It has scores of 0 to 100 points, where 100 means no pain and / or functional limitations and 0 means constant pain and several functional limitations (KUJALA et al, 1993). The Anterior Knee Pain Scale is a reliable and valid instrument to evaluate the function in individuals with PFP (CROSSLEY et al, 2004). The final score will be used for statistical analysis.

    Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)

Secondary Outcomes (4)

  • Kinesiophobia

    Pre (baseline) treatment and post treatment (12 weeks)

  • Self-perception of improvement

    Pre (baseline) treatment and post treatment (12 weeks)

  • Change Quality of Life

    Pre (baseline) treatment and post treatment (12 weeks)

  • Maximal Isometric Torque and Rate of Force Development (RFD)

    Pre (baseline) treatment and post treatment (12 weeks)

Study Arms (2)

Strength Training Group (STG)

ACTIVE COMPARATOR

The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015). Initially, the goal will be the development of neuromotor control and resistance (load \<50% of the one repetition maximum test \[1RM\]), and in subsequent weeks the goal will be the development of muscle strength (load\> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included.

Other: Strength Training Group (STG)

Strength and Power Training Group (SPTG)

EXPERIMENTAL

Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load \<50% of the one repetition maximum test \[1RM\]). However, in subsequent weeks the goal will be to develop strength (load\> 70% 1RM) and muscle power (load between 40-60% 1RM).

Other: Strength and Power Training Group (SPTG)

Interventions

The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015). Initially, the goal will be the development of neuromotor control and resistance (load \<50% of the one repetition maximum test \[1RM\]), and in subsequent weeks the goal will be the development of muscle strength (load\> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included.

Strength Training Group (STG)

Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load \<50% of the one repetition maximum test \[1RM\]). However, in subsequent weeks the goal will be to develop strength (load\> 70% 1RM) and muscle power (load between 40-60% 1RM).

Strength and Power Training Group (SPTG)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men and women with bilateral or unilateral patellofemoral pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriela Souza de Vasconcelos

São Carlos, São Paulo, 91360-010, Brazil

RECRUITING

Related Publications (2)

  • Vasconcelos GS, Nunes GS, Munhoz RF, da Silva MECB, Pisani GK, Luz BC, Serrao FV. Is strength and power training targeting hip and knee muscles superior to strength training in individuals with patellofemoral pain? Proof of concept study. Sci Rep. 2024 Nov 10;14(1):27450. doi: 10.1038/s41598-024-78074-2.

  • 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.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Gabriela S de Vasconcelos, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduate

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 13, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2019

Study Completion

July 1, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations