Shoulder Pain Clinical Trial
Official title:
Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
Determine if adding "extra-gravity" (sustained increase in vertical loading) during standard rehabilitation exercises has a beneficial effect on pain reduction in subjects suffering from shoulder pain of different origin.
Standard rehabilitation protocols will be used with every subject, depending on the cause of
their shoulder pain. The treating clinician will determine the appropriate therapy protocol
for each subject.
During the treatment sessions, subjects will wear a very comfortable waist belt attached
with rubber band to anchor points on the ground (the rubber bands will be tighten to
simulate the extra-gravity).
Upon enrollment, the treating clinician will randomly assign the subject to one of four
groups depending on the type of loading and exercise typology.
The hyper-gravity will be simulated as an additional 50% of subject's body weight.
The frequency and duration of each therapy session will be determined by the treating
clinician (usually 45 minutes of therapy twice a week for 4 weeks).
Before, after and 24h post therapy session, the subject will grade the pain level using a
numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication).
As part of the rehabilitation therapy procedure, subjects will undergo shoulder range of
motion evaluations (done by a trained clinician in approximately 3 minutes) and Computer
Dynamic Posturography (CDP) testing on a 4" tall foam cushion with eyes closed (PSEC test -
less than 1 minute of testing) before and after each therapy session.
Subjects will complete the DASH and TOSSA questionnaires (the total amount of time required
to complete these assessment is ~20 minutes), and will be tested using the modified Clinical
Testing of Sensory Integration in Balance (mCTSIB) protocol (the subjects will be required
to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical
properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head
straight and arms to the side and free to move, gazing forward, and breathing normally, less
than 2 minutes testing time) at the time of enrollment and at the end of the 4 week therapy
program.
Subjects will be asked to come back for two more evaluations (questionnaires, range of
motion assessment, and CDP testing) one month and three months after the end of the 4 week
therapy program to identify possible long term effects of the "hyper-gravity/accentuated
vertical loading" therapy.
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