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The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy

Primary Purpose

Tendinopathy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Isometric Exercise

Sham Transcutaneous Electrical Nerve Stimulation

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring Exercise, Physical Activity, Biomechanics

Eligibility Criteria

15 Years - 28 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

The investigators will recruit a convenience sample of participants who meet the following overall criteria:

Age 15 and post-pubertal (confirmed by Pubertal Development Scale Questionnaire) - 28 years
Actively participating within an organized sport setting (high school, collegiate, club, competitive intramural sports) in their respective team's weekly training and competitions, quantified by a Tegner Activity Level Scale of at least 5.

Exclusion Criteria:

The following exclusion criteria will be applied to all participants:

Any anterior knee pain with no patellar tendon abnormality on ultrasound assessment.
History of any knee joint surgery ever.
History of other (non-knee) lower extremity surgery in the last 1 year.
History of lower extremity injury in last 6 months (other than patellar tendinopathy).
An injection (corticosteroids, plasma-rich-protein, etc.) to the patellar tendon in the last 3 months.
Known history of osteoarthritis or current symptoms related to osteoarthritis (i.e. stiffness, swelling).
Participation in formal rehabilitation for patellar tendinopathy in prior 3 months
Known neurological disorders, including: stroke, multiple sclerosis, ALS, diabetic neuropathy, epilepsy, traumatic brain injury resulting in loss of consciousness, concussion within the last 6 months, cranial neural surgery, balance disorders.
Use of pacemaker or another implantable electronic device.
History of cardiac arrhythmia or any cardiac condition.
History of psychiatric disorder. *
History of cancer in the brain or thigh musculature.
Pubertal Development Scale Score < 12 (Stages 1-4)
- Note: Rationale for exclusion of individuals with a history of psychiatric disorders is that these individuals may have taken or be taking pharmacological agents that could affect pain or neuromuscular control.

Sites / Locations

Sports Medicine Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Isometric Exercise Condition

Sham TENS Condition

Arm Description

The participant will perform 5 sets of a 45-second isometric contractions at 70% of their maximum voluntary isometric contraction (MVIC). During the 45-second contraction, the participant will be provided with visual biofeedback on a computer screen (70% MVIC target line and +/- 5% error lines). The participant will be instructed to produce a level of isometric quadriceps contraction that maintains the isometric torque output line as close the target line as possible and always between the two error lines.

Two electrodes of the Select System TENS unit (Empi, Inc., St. Paul, MN) will be placed on either side of the patellar tendon on the test limb. The same instruction script will be used for each participant, stating, "A surface electrode has been placed on either side of your patellar tendon. I will turn on the stimulation unit to emit a stimulus to your patellar tendon. This is a special sub-sensory stimulation treatment, so you will not feel anything during this period as the stimulus is set at a very low, non-detectable threshold. Please remain still during this 45-second period, letting your leg rest passively in the machine without contracting your leg muscles. After the 45-second period, the stimulation unit will be turned off and you will have a 2-minute rest period. We will repeat this same treatment/rest sequence 5 total times."

Outcomes

Primary Outcome Measures

Difference in the change in mean internal knee extension moment during landing between groups

Angular force or moment will be measured in Nm/kg*m where "Nm" represents angular force and "kg*m" represents normalization to body weight and height.

Difference in the change in mean internal hip flexion moment during landing between groups

Angular force or moment will be measured in Nm/kg*m where "Nm" represents angular force and "kg*m" represents normalization to body weight and height.

Difference in the change in mean peak vertical ground reaction force during landing between groups

Vertical ground reaction force will be measured in N(BW) where "N" is a measure of force and "BW" represents normalization to body weight.

Difference in the change in mean peak vertical ground reaction force loading rate during landing between groups

Vertical ground reaction force loading rate will be measured in N(BW)/s where "N" is a measure of force and "BW" represents normalization to body weight and "s" is the time unit seconds.

Difference in the change in mean peak patellar tendon force during landing between groups

Patellar tendon force will be measured in N(BW) where "N" is a measure of force and "BW" represents normalization to body weight.

Secondary Outcome Measures

Difference in average steps-per-day between groups

Steps-per-day calculated by an ActiGraph GT9X Link Accelerometer (ActiGraph Corporation, Pensacola, FL) wearable physical activity device worn at the hip using a belt clip.

Difference in average minutes of moderate-to-vigorous physical activity (MVPA) between groups

MVPA calculated by an ActiGraph GT9X Link Accelerometer (ActiGraph Corporation, Pensacola, FL) wearable physical activity device worn at the hip using a belt clip.

Difference in change in anterior knee pain (self-reported via visual analog scale (0-10)) between groups

A standard visual analog scale (0-10) will be utilized to assess pain, where 0=complete absence of pain and 10=worst pain imaginable (higher scores indicate worse pain). This scale will be delivered verbally and the participants will respond verbally.

Full Information

NCT ID

NCT03262181

First Posted

August 22, 2017

Last Updated

February 15, 2019

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Foundation for Physical Therapy, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03262181

Brief Title

The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy

Official Title

The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

September 15, 2017 (Actual)

Primary Completion Date

April 20, 2018 (Actual)

Study Completion Date

April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Foundation for Physical Therapy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine differences in lower extremity landing biomechanics and real-world physical activity between individuals with patellar tendinopathy compared to individuals without patellar tendinopathy,and to determine the acute effects of an isometric loading intervention on lower extremity landing biomechanics in individuals with patellar tendinopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tendinopathy

Keywords

Exercise, Physical Activity, Biomechanics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Masking Description

Participants are masked to their group assignment until the end of the study. Investigator is masked to intervention condition.

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Isometric Exercise Condition

Arm Type

Experimental

Arm Description

Arm Title

Sham TENS Condition

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Isometric Exercise

Other Intervention Name(s)

Therapeutic Exercise

Intervention Description

5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.

Intervention Type

Other

Intervention Name(s)

Sham Transcutaneous Electrical Nerve Stimulation

Other Intervention Name(s)

Sham TENS

Intervention Description

5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.

Primary Outcome Measure Information:

Title

Difference in the change in mean internal knee extension moment during landing between groups

Description

Angular force or moment will be measured in Nm/kg*m where "Nm" represents angular force and "kg*m" represents normalization to body weight and height.

Time Frame