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

NCT03196063 | Terminated DMC

• 1 other identifier: UNICID16
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise Therapy; Heavy Slow Resistance Program; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Pain intensity during rest

  12 weeks and 6 months after randomization

• Functional capacity

  12 weeks and 6 months after randomization

• Pain intensity during squat

  8 weeks after randomization

• Pain intensity

  Eigth weeks, before and after each intervention session

• Triple hop test

  8 weeks after randomization

Study Arms (2)

Eccentric

ACTIVE COMPARATOR

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.

Other: Eccentric

Modified protocol

EXPERIMENTAL

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.

Other: Modified Protocol

Interventions

Eccentric 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.

Also known as: Eccentric exercise

Eccentric

Modified Protocol 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.

Also known as: Heavy Slow Resistance Program

Modified protocol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Physical Therapy Outpatient Department

São Paulo, 03071000, Brazil

Location

Study Officials

• Cristina MN Cabral, PhD

  Universidade Cidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: July 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 30, 2018
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)