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

NCT ID: NCT03196063

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2018-12-30

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.

Conditions

Patellar Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Eccentric

Patients allocated in this group will perform three sets of 15 unipodal squats with the affected limb on an inclined plane. The patient will be instructed to perform only the eccentric phase of the exercise, keeping the torso erect and flexing the knee up to 90 degrees. The return to the initial position will be performed with the unaffected leg. To increase exercise load, the patient will carry a bag with washers. This protocol will last eight weeks, with 24 face-to-face sessions.

Both groups will also receive a protocol with complementary isotonic exercises, focusing on the strengthening of gluteus maximus, gluteus medius, hamstrings and calves.

Group Type: ACTIVE_COMPARATOR

Eccentric

Intervention Type: OTHER

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

Patients allocated in this group will receive treatment based on a protocol published in a clinical practice guide, with modifications to make the protocol more pragmatic. Thus, the use of mechanotherapy devices will be replaced by free weight exercises, so that the protocol can be performed in environments that do not offer this type of machinery. This protocol is composed of four exercise stages, being the first three stages performed in the presence of the physiotherapist, and will last eight weeks with approximately 24 face-to-face sessions.

Both groups will receive a protocol with complementary isotonic exercises, focusing on the strengthening of gluteus maximus, gluteus medius, hamstrings and calves.

Group Type: EXPERIMENTAL

Modified Protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Eccentric exercise; Heavy Slow Resistance Program

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Cristina Maria Nunes Cabral

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina MN Cabral, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Locations

Physical Therapy Outpatient Department

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

UNICID16

Identifier Type: -

Identifier Source: org_study_id