Effectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy

Patellar Tendinopathy Clinical Trial

Official title:

Effectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03196063
• Other study ID #: UNICID16
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: November 2019
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellar Tendinopathy
• Tendinopathy

Intervention

Other:
• Eccentric
Exercises based on eccentric contractions of the quadriceps femoris muscle, using a 15º inclined plane. A serie of 15 repetitions of the squat will be performed, with the frequency of three times a week for eight weeks. The load of the exercises will be increased weekly.
• Modified Protocol
Protocol based on the Heavy Slow resistance program, with the addition of an isometric phase at the beginning of the protocol, and with exercises using body weight without the use of mechanotherapy.

Locations

Country	Name	City	State
Brazil	Physical Therapy Outpatient Department	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity during rest	This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be." The participant will classify his average pain in the last 7 days.	8 weeks after randomization
Primary	Functional capacity	VISA-P questionnaire assesses the symptoms and disability of patients with patellar tendinopathy. It is a questionnaire with eight questions, six of them on a Likert scale, ranging from 0 to 10 points, where 0 represents the maximum severity of the disease and 10 represents no pain or limitation. Question 7 has four possible answers (0, 4, 7 and 10 points). Question 8 has a subdivision (8A, 8B and 8C), in which only one can be answered, depending on the perception of pain during sport activities, varying up to 30 points. The total score of the questionnaire varies between 0 and 100 points, with 100 points corresponding to the absence of pain or disability.	8 weeks after randomization
Secondary	Pain intensity during rest	This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be." The participant will classify his average pain in the last 7 days.	12 weeks and 6 months after randomization
Secondary	Functional capacity	VISA-P questionnaire assesses the symptoms and disability of patients with patellar tendinopathy. It is a questionnaire with eight questions, six of them on a Likert scale, ranging from 0 to 10 points, where 0 represents the maximum severity of the disease and 10 represents no pain or limitation. Question 7 has four possible answers (0, 4, 7 and 10 points). Question 8 has a subdivision (8A, 8B and 8C), in which only one can be answered, depending on the perception of pain during sport activities, varying up to 30 points. The total score of the questionnaire varies between 0 and 100 points, with 100 points corresponding to the absence of pain or disability.	12 weeks and 6 months after randomization
Secondary	Pain intensity during squat	This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be". The patient will classify his pain during a complete isotonic unipodal squat on an inclined plane.	8 weeks after randomization
Secondary	Pain intensity	This outcome will be evaluated by an 11-point scale ranging from 0 to 10, in which 0 represents "no pain" and 10 represents "pain as bad as it could be". The patient will rate the pain during rest before and after each intervention session.	Eigth weeks, before and after each intervention session
Secondary	Triple hop test	The patient will perform a test composed of three consecutive jumps, as far as possible, always landing on the same foot.	8 weeks after randomization
Secondary	Pressure pain threshold	The patient will perform 10 repetitions of the complete unipodal squat on an inclined plane and sequentially will be placed on a stretcher lying comfortably with the knee flexed at 20 degrees. The patient should indicate the point of greatest pain in the tendon, which will be marked to be the location of the tip of the algometer, and the distance to the apex of the patella will be measured to use the same point in the assessment after treatment. If the patient does not present pain in the assessment after treatment, the point standardized in the initial evaluation will be used. If the patient still presents pain, the point of greatest pain will be evaluated. For measurement, pressure will be applied until the patient experiences a mild pain sensation (pain level 1), when he will be instructed to press the algometer button to stop the test.	8 weeks after randomization
Secondary	Muscular strength	The hand dynamometer will be used to measure the strength of the quadriceps femoris, hamstring, gluteus maximus, gluteus medius and lateral hip rotators.	8 weeks after randomization