Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06465394 |
| Other study ID # |
IRB-24-100 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 12, 2024 |
| Est. completion date |
May 5, 2025 |
Study information
| Verified date |
June 2024 |
| Source |
University of South Dakota |
| Contact |
Kory J Zimney, PhD |
| Phone |
6056586373 |
| Email |
kory.zimney[@]usd.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Exercised induced hypoalgesia (EIH) (reduction in pain) after exercise has been studied in
the literature, but no comparisons have been made specifically looking at different types of
exercise (isometric/dynamic moving through a range of motion with resistance versus
isotonic/applying static resistance to a joint not moving) with neck muscle strengthening.
This study will explore to see if one form of exercise is superior to the other in providing
EIH.
Another benefit of exercise is improving proprioception (knowing where our body is in space).
Again no specific investigation has been done comparing isometric versus isotonic exercises
for neck muscles.
Both of these exercises are often prescribed in physical therapy so further understanding the
benefits of them can help improve the prescription of exercises for patients.
Description:
After consent has been obtained, participants will be asked the screening questions to
confirm eligibility for the study. The researcher will then ask the participants demographic
questions and record the responses for age, gender, racial category, and handedness.
Odd-numbered participants will perform isometric exercises first and then isotonic exercises
on the second day. Even numbered participants will perform isotonic exercises first and then
isometric exercises on the second day. There will be 2-3 days between each test period.
Testing each time will have participants do baseline measurements for pain pressure threshold
(PPT) and proprioception (JPE), exercise protocol, and then retest PPT and JPE post exercise.
Pain pressure threshold testing consists of measuring the distance between C7 and the distal
aspect of the acromion while the participant is seated. If possible, the shirt will be
removed for men, or the neck color pulled to the side for females. If unable to move the
shirt to the side, the testing can be done over the clothing. The mid-way point will be
marked with a pen or other method to indicate the location on the upper trap muscle where the
PPT testing will be performed on both the right and left sides. Utilization of a pressure
algometer will be used for testing with a 1 cm2 rubber tip. The pressure algometer tip will
be placed on the mark of the midpoint of the upper trap previously measured and marked.
Pressure is slowly applied until the participant reports a change from pressure to pain and
says "STOP". At the moment the participant says stop, the pressure is stopped, and the
recording is measured. There will be 3 tests with PPT on both right and left alternating
between each side with testing.
Proprioception is measured by the joint position error (JPE) test. This test requires the
patient to place a headlamp equipped with a laser pointer. They will be seated in a chair
facing a wall with the JPE target on the wall. The subject is to sit with their head in a
normal resting state, looking straight ahead. The target is adjusted to the participant's
baseline. The participant is instructed to get a "sense" of this position. The participant
then moves their head/neck to the right or left, returning to their resting position. The
subject then closes their eyes and completed 6 trials of turning their head to the right and
6 trials to the left. The researcher will assist them in recentering to their start position
each time before the next rotation of the head/neck.
Once the baseline PPT and JPE are measured, the subjects will go through the exercise
protocol.
Isometric test protocol. Participants will be asked to perform the exercise at a moderate
exercise level (3/10 on the mRPE scale provided to them). They will complete a 1, 10-second
isometric hold to their hand dominant side (if ambidextrous, the side the participant would
report as the most dominant side) to allow them to find their "moderate" intensity level. The
participant will then take a 2-minute rest before beginning the exercise routine and will be
instructed to keep a consistent resistance level during the exercise bout. During the
exercise, the subjects will hold the rotation contraction for 10 seconds, take a 2-second
rest, complete this 5 times, and then change to the left side. They will do this for 3 sets
of right and left. Researchers will time the exercises and give verbal instructions to make
sure they are performing for the appropriate amount of time and rest periods. After
completing the exercise protocol, they will complete the PPT and JPE tests in the same way as
was done for baseline measurement.
Isotonic test protocol. Participants will be asked to perform the exercise at a moderate
exercise level (3/10) on the mRPE scale provided to them). They will complete 2 reps using
the red rubber band resistance on the 'NecksLevel' neck strengthening device, moving through
a full range of motion toward their hand-dominant side as they will do in the isometric test.
After completing the 2 test reps, they will be asked if they would like to increase or
decrease the resistance to be at a moderate level. The new resistance level or staying the
same level will then be done for 3 more reps to ensure they are at a moderate level. The
participants will then take a 2-minute rest before beginning the exercise routine. The
resistance level will stay at the participant's selected moderate level during the entire
testing unless they need to stop due to pain or difficulty completing the exercise. During
the exercise, the participants will be rotating to the right first at a pace of 1 second for
concentric contraction to full rotation and 1 second for eccentric contraction, returning the
head to the neutral position. The participant will continue this pace to complete 5
repetitions and then take a 2-second rest before continuing this sequence 5 times (a total of
25 reps) before switching and doing left rotation in the same fashion. This will be done for
a total of 3 sets for both right and left rotation. The use of a metronome will be used along
with the researcher's verbal instructions and cueing to maintain the proper sequence and
timing of the exercise. After completing the exercise protocol, they will complete the PPT
and JPE tests in the same way as was done for baseline measurement.
