Skip to main content
OpenTrials
Completed

NCT Number: NCT03262181

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–28 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sports Medicine Research Laboratory

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Isometric exercise

Other

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

Other names: Therapeutic Exercise

Sham Transcutaneous Electrical Nerve Stimulation

Other

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

Other names: Sham TENS

Primary outcomes

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

    Time frame: Pre- and post-intervention condition (~30 minutes)

    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.

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

    Time frame: Pre- and post-intervention condition (~30 minutes)

    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.

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

    Time frame: Pre- and post-intervention condition (~30 minutes)

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

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

    Time frame: Pre- and post-intervention condition (~30 minutes)

    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.

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

    Time frame: Pre- and post-intervention condition (~30 minutes)

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

Secondary outcomes

  1. Difference in average steps-per-day between groups

    Time frame: Day 1 - Day 7

    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.

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

    Time frame: Day 1 - Day 7

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

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

    Time frame: Pre- and post-intervention condition (~10 minutes)

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Foundation for Physical Therapy, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 25, 2017
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.