Back to resultsEffectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy
Primary Purpose
Patellar Tendinopathy
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Eccentric
Modified Protocol
Sponsored by
About this trial
This is an interventional treatment trial for Patellar Tendinopathy focused on measuring Exercise Therapy, Heavy Slow Resistance Program, Rehabilitation
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.
Sites / Locations
- Physical Therapy Outpatient Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Eccentric
Modified protocol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Triple hop test
The patient will perform a test composed of three consecutive jumps, as far as possible, always landing on the same foot.
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.
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.
Full Information
NCT ID
NCT03196063
First Posted
June 20, 2017
Last Updated
November 13, 2019
Sponsor
Universidade Cidade de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03196063
Brief Title
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
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Study stopped because we could not recruit patients in the available time
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinopathy
Keywords
Exercise Therapy, Heavy Slow Resistance Program, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eccentric
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Eccentric
Other Intervention Name(s)
Eccentric exercise
Intervention Description
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
Intervention Name(s)
Modified Protocol
Other Intervention Name(s)
Heavy Slow Resistance Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity during rest
Description
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.
Time Frame
8 weeks after randomization
Title
Functional capacity
Description
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.
Time Frame
8 weeks after randomization
Secondary Outcome Measure Information:
Title
Pain intensity during rest
Description
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.
Time Frame
12 weeks and 6 months after randomization
Title
Functional capacity
Description
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.
Time Frame
12 weeks and 6 months after randomization
Title
Pain intensity during squat
Description
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.
Time Frame
8 weeks after randomization
Title
Pain intensity
Description
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.
Time Frame
Eigth weeks, before and after each intervention session
Title
Triple hop test
Description
The patient will perform a test composed of three consecutive jumps, as far as possible, always landing on the same foot.
Time Frame
8 weeks after randomization
Title
Pressure pain threshold
Description
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.
Time Frame
8 weeks after randomization
Title
Muscular strength
Description
The hand dynamometer will be used to measure the strength of the quadriceps femoris, hamstring, gluteus maximus, gluteus medius and lateral hip rotators.
Time Frame
8 weeks after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina MN Cabral, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy Outpatient Department
City
São Paulo
ZIP/Postal Code
03071000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Two Exercise Protocols in the Treatment of Patients With Patellar Tendinopathy
We'll reach out to this number within 24 hrs