Shoulder PainNCT02589184
Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
A study testing Hypergravity, isometric load and normal gravity in people with Shoulder Pain, run by Carrick Institute for Graduate Studies at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Hypergravity, isometric load and normal gravity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)
Who cannot join
- adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption
Trial locations and contacts
2 sites in 1 country.
United States2 sites
FIFE Therapy
Savannah, Georgia, 31404
Optim Orthopedics - DeRenne
Savannah, Georgia, 31405
About this study
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.
Read the detailed description
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.
- Conditions
- Shoulder Pain
- Being tested
- Hypergravity, isometric load, normal gravity
- Keywords
- balance, postural, postural equilibrium, pain scale, range of motion
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypergravityOther
the rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing
isometric loadOther
at the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load
normal gravityOther
the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity
| Study group | Role | What they receive |
|---|---|---|
| hypergravity WITH isometric load | Experimental | Patient performing rehabilitation exercises under hypergravity as well as loaded isometric squats Receives: Other: Hypergravity; Other: isometric load |
| hypergravity WITHOUT isometric load | Experimental | Patient performing rehabilitation exercises under hypergravity Receives: Other: Hypergravity |
| normal gravity WITH isometric load | Experimental | Patient performing rehabilitation exercises under normal gravity as well as loaded isometric squats Receives: Other: isometric load; Other: normal gravity |
| normal gravity WITHOUT isometric load | Active comparator | Patient performing rehabilitation exercises under normal gravity Receives: Other: normal gravity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain level
The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication).
Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Measured: three months
Secondary outcomes (4)
Changes in Stability Score
The Stability Score is calculated as percentage ratio of the actual sway and the theoretical limit of stability.
Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Measured: three months
Changes in shoulder range of motion
It is measured as shoulder abduction through "Scaption Range", external / internal rotation in abduction at 90 degrees, and single arm overhead press motion.
Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Measured: three months
Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
A 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.
Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Measured: three months
Test of Sustained Selective Attention (TOSSA)
An 8-minute computerized auditory sustained attention test. Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Logistics reason at the data collection site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carrick Institute for Graduate Studies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
- Investigators
- Frederick R Carrick, PhD, Principal investigator, Carrick Institute for Graduate Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589184
- Sponsor's protocol ID
- CI-IRB-20150818006A
- Status last verified
- Feb 2017
- First submitted
- 23 Oct 2015
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Shoulder Pain of Simulated Hyper-gravity During Rehabilitation Exercises
- ClinicalTrials.gov ID
- NCT02589184
- Acronym / sponsor ID
- CI-IRB-20150818006A
- Conditions
- Shoulder Pain
- Keywords
- balance, postural, postural equilibrium, pain scale, range of motion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics reason at the data collection site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Carrick Institute for Graduate StudiesUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| hypergravity WITH isometric load | Experimental | Other: Hypergravity, Other: isometric loadPatient performing rehabilitation exercises under hypergravity as well as loaded isometric squats |
| hypergravity WITHOUT isometric load | Experimental | Other: HypergravityPatient performing rehabilitation exercises under hypergravity |
| normal gravity WITH isometric load | Experimental | Other: isometric load, Other: normal gravityPatient performing rehabilitation exercises under normal gravity as well as loaded isometric squats |
| normal gravity WITHOUT isometric load | Active comparator | Other: normal gravityPatient performing rehabilitation exercises under normal gravity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of shoulder pain (potentially including rotator cuff pathology, impingement, bursitis, SLAP tear)
Key exclusion criteria (1 listed)
- adhesive capsulitis, fracture, dislocation, inflammatory arthritis, cancer, ligament disruption
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 |
|---|---|---|
| Hypergravitythe rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing | Other | hypergravity WITH isometric load, hypergravity WITHOUT isometric load |
| isometric loadat the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load | Other | hypergravity WITH isometric load, normal gravity WITH isometric load |
| normal gravitythe rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity | Other | normal gravity WITH isometric load, normal gravity WITHOUT isometric load |
Primary outcome
Changes in pain level
Time frame: three months
The patient will grade the pain level using a numeric pain scale (0 no pain; 10 unbearable pain requiring pain medication). Changes will be assessed between baseline (before therapy sessions) and three month post therapy. It will be used to investigate if there is any statistical difference between the different therapies.
4 secondary outcomes
Changes in Stability Score
Time frame: three months
Changes in shoulder range of motion
Time frame: three months
Changes in Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time frame: three months
Test of Sustained Selective Attention (TOSSA)
Time frame: three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2017.
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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.
Frederick R Carrick, PhD principal investigator
Carrick Institute for Graduate Studies
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypergravity, isometric load and normal gravity in people with Shoulder Pain, run by Carrick Institute for Graduate Studies at 2 sites 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in pain level (time frame: three months). 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 20 Feb 2017.