TendinopathyNCT03262181
The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
A study testing Isometric Exercise in people with Tendinopathy, run by University of North Carolina, Chapel Hill at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 15 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Isometric Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 20 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 28 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sports Medicine Research Laboratory
Chapel Hill, North Carolina, 27599
About this study
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.
- Conditions
- Tendinopathy
- Being tested
- Isometric Exercise, Sham Transcutaneous Electrical Nerve Stimulation
- Keywords
- Exercise, Physical Activity, Biomechanics
- Medical subject headings
- Tendinopathy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric ExerciseOther
Also called Therapeutic Exercise
5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.
Sham Transcutaneous Electrical Nerve StimulationOther
Also called Sham TENS
5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.
| Study group | Role | What they receive |
|---|---|---|
| Isometric Exercise Condition | Experimental | 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. Receives: Other: Isometric Exercise |
| Sham TENS Condition | Sham comparator | 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." Receives: Other: Sham Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre- and post-intervention condition (~30 minutes)
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.
Measured: Pre- and post-intervention condition (~30 minutes)
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.
Measured: Pre- and post-intervention condition (~30 minutes)
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.
Measured: Pre- and post-intervention condition (~30 minutes)
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.
Measured: Pre- and post-intervention condition (~30 minutes)
Secondary outcomes (3)
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.
Measured: Day 1 - Day 7
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.
Measured: Day 1 - Day 7
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.
Measured: Pre- and post-intervention condition (~10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start15 Sep 2017
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Responsible party
- Sponsor
- Investigators
- Darin A Padua, PhD, ATC, Study chair, Professor and Department ChairLaura E Stanley, DPT, Principal investigator, Graduate Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262181
- Sponsor's protocol ID
- 17-1731
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT03262181
- Acronym / sponsor ID
- 17-1731
- Conditions
- Tendinopathy
- Keywords
- Exercise, Physical Activity, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc.
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric Exercise Condition | Experimental | Other: Isometric ExerciseThe 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. |
| Sham TENS Condition | Sham comparator | Other: Sham Transcutaneous Electrical Nerve StimulationTwo 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." |
Who may qualify
- Ages
- 15 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric ExerciseAlso: Therapeutic Exercise5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest. | Other | Isometric Exercise Condition |
| Sham Transcutaneous Electrical Nerve StimulationAlso: Sham TENS5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest. | Other | Sham TENS Condition |
Primary outcome
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.
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.
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.
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.
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.
3 secondary outcomes
Difference in average steps-per-day between groups
Time frame: Day 1 - Day 7
Difference in average minutes of moderate-to-vigorous physical activity (MVPA) between groups
Time frame: Day 1 - Day 7
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darin A Padua, PhD, ATC study chair
Professor and Department Chair
Laura E Stanley, DPT principal investigator
Graduate Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric Exercise in people with Tendinopathy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the change in mean internal knee extension moment during landing between groups (time frame: Pre- and post-intervention condition (~30 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.