An interventional study of Isometric Exercise and Sham Transcutaneous Electrical Nerve Stimulation in Tendinopathy, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to male participants aged 15 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-19.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
Among 99 studies in Tendinopathy with a site in United States — 15 open to participants now, 17 under way, none of them phase 3. Tendinopathy · United States.
Among the 99 studies in Tendinopathy with a site in United States, this one is the 40th largest by enrollment of the 89 interventional ones that give a count, is one of 10 that started in 2017, is one of 49 with no phase, and was the 44th registered.
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
Browse Tendinopathy studies →15 of the 99 studies in Tendinopathy with a site in United States are open now. Recruiting first, the newest first:
Weill Medical College of Cornell University · Sites in United States
Joint & Vascular Institute · Sites in United States
The University of Texas Medical Branch, Galveston · Sites in United States
University of Utah · Sites in United States
Brigham and Women's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 47 Tendinopathy studies recruiting now, 16 (34%) set no upper age limit and 24 (51%) stop at 75 or younger; 1 take children under 18; 7 take healthy volunteers.
This study: 15 Years to 28 Years · male · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
99 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 12 · Phase 3 8 · Phase 4 15
First in 2002; this study’s year is marked. 10 started in 2017.
This study's enrollment of 43 is below the median of 48 across 332 interventional studies indexed under Tendinopathy.
Median enrollment 40 across the 89 interventional studies, 66 across the 10 observational. Of the 68 that completed or were terminated, 25 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 99 have an industry lead sponsor. The 10 most frequent:
University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
University of North Carolina, Chapel Hill has 1 study filed under Tendinopathy — fewer than ten, so there is no comparison to draw.
8 of the studies in Tendinopathy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06160427Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Connective Tissue Matrix for Rotator Cuff Tendinopathy | 2027-01-15 |
| NCT06095050Brigham and Women's HospitalEmbolization Treatment of Chronic Refractory Shoulder Tendinopathy | 2027-01-16 |
| NCT07642583Brooke Army Medical CenterDry Needling and Exercise for Mid-portion Achilles Tendinopathy | 2027-03-30 |
| NCT07553273The University of Texas Medical Branch, GalvestonVibratory Anesthesia on Pain Following Corticosteroid Injections | 2027-04 |
| NCT02600910The University of Texas Medical Branch, GalvestonNatural History of Shoulder Pathology in Manual Wheelchair Users | 2027-06 |
Among the 99 studies in Tendinopathy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The investigators will recruit a convenience sample of participants who meet the following overall criteria:
Exclusion Criteria:
The following exclusion criteria will be applied to all participants:
Pubertal Development Scale Score \< 12 (Stages 1-4)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Isometric Exercise
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."
Other: Sham Transcutaneous Electrical Nerve Stimulation
5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.
Also known as: Therapeutic Exercise
5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.
Also known as: Sham TENS
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre- and post-intervention condition (~30 minutes)
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.
Time frame: 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.
Time frame: 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.
Time frame: Pre- and post-intervention condition (~10 minutes)
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Apr 2018, 7 months.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 7 months is below that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill →