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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262181
• Other study ID #: 17-1731
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: February 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 28 Years

Eligibility

Inclusion Criteria:

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

1. Age 15 and post-pubertal (confirmed by Pubertal Development Scale Questionnaire) - 28 years

2. 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:

1. Any anterior knee pain with no patellar tendon abnormality on ultrasound assessment.

2. History of any knee joint surgery ever.

3. History of other (non-knee) lower extremity surgery in the last 1 year.

4. History of lower extremity injury in last 6 months (other than patellar tendinopathy).

5. An injection (corticosteroids, plasma-rich-protein, etc.) to the patellar tendon in the last 3 months.

6. Known history of osteoarthritis or current symptoms related to osteoarthritis (i.e. stiffness, swelling).

7. Participation in formal rehabilitation for patellar tendinopathy in prior 3 months

8. 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.

9. Use of pacemaker or another implantable electronic device.

10. History of cardiac arrhythmia or any cardiac condition.

11. History of psychiatric disorder. *

12. History of cancer in the brain or thigh musculature.

13. 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.

Related Conditions & MeSH terms

• Tendinopathy

Intervention

Other:
• Isometric Exercise
5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.
• Sham Transcutaneous Electrical Nerve Stimulation
5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.

Locations

Country	Name	City	State
United States	Sports Medicine Research Laboratory	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Foundation for Physical Therapy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre- and post-intervention condition (~30 minutes)
Primary	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.	Pre- and post-intervention condition (~30 minutes)
Primary	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.	Pre- and post-intervention condition (~30 minutes)
Primary	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.	Pre- and post-intervention condition (~30 minutes)
Primary	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.	Pre- and post-intervention condition (~30 minutes)
Secondary	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.	Day 1 - Day 7
Secondary	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.	Day 1 - Day 7
Secondary	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.	Pre- and post-intervention condition (~10 minutes)