Clinical trial NCT03196063: Effectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy
Official title: Effectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patellar Tendinopathy
Keywords: Exercise Therapy
Heavy Slow Resistance Program
Rehabilitation
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patellar tendinopathy is characterized by anterior pain in the knee, due to the great demand imposed on the extensor mechanism of the knee. Evidence shows that the most appropriate treatment for this condition is the conservative treatment, through strengthening with eccentric exercises. However, a recent editorial proposes a new treatment protocol based on concentric and eccentric exercises, with the initial prescription of isometric exercises. The hypothesis of this study is that the protocol is as good as the eccentric exercises, generating less pain.


Eligibility criteria: Inclusion Criteria:

* patients with chronic unilateral patellar tendinopathy confirmed by the reproduction of the pain during the palpation test in the region of the lower pole of the patella
* presence of pain for three months or more
* both genders
* body mass index less than 30 kg/m²
* age between 18 and 40 years
* practice of physical activity on a regular basis
* pain intensity ≥ 3 points on the pain numerical rating scale in the anterior region of the knee, specifically in the region of the lower pole of the patella when performing squatting, jumping or activities with change of direction
* score \< 80 points on the Victorian Institute of Sport Assessment-Patella (VISA-P)
* blazine functional scale between 1 and 3

Exclusion Criteria:

* patients who have previous pain in the knee that does not correspond to patellar tendinopathy
* previous rupture of the patellar tendon (blazin functional scale at level 4)
* previous surgery or infiltration of the patellar tendon in the last six months
* inflammatory diseases
* diabetes mellitus
* lower limbs injuries
* other chronic pain conditions that prevent exercise, such as severe hip and knee osteoarthrosis and joint fractures.

Primary outcomes:
measure: Pain intensity during rest
timeFrame: 8 weeks after randomization
measure: Functional capacity
timeFrame: 8 weeks after randomization
Secondary outcomes:
measure: Pain intensity during rest
timeFrame: 12 weeks and 6 months after randomization
measure: Functional capacity
timeFrame: 12 weeks and 6 months after randomization
measure: Pain intensity during squat
timeFrame: 8 weeks after randomization
measure: Pain intensity
timeFrame: Eigth weeks, before and after each intervention session
measure: Triple hop test
timeFrame: 8 weeks after randomization
measure: Pressure pain threshold
timeFrame: 8 weeks after randomization
measure: Muscular strength
timeFrame: 8 weeks after randomization
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Physical Therapy Outpatient Department
Study officials:
affiliation: Universidade Cidade de São Paulo
name: Cristina MN Cabral, PhD
role: PRINCIPAL_INVESTIGATOR
References: