DegenerationSodisowNCT01263184
Symptoms of Degeneration in Shoulder of Wheelchair-users
An observational study of Degeneration and Shoulder Pain, run by Hannover Medical School at 1 site in Germany.
Trial summary
The studies object is to evaluate the degeneration of overhead sports in wheelchair-using athletes. It is assumed that wheelchair users do have more symptomatic shoulder pain compared to non disabled athletes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Degeneration, Shoulder Pain
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to not given
- Phase
- Observational
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: wheelchair users, sportiv people
Who may be able to join
- capability of doing sports
Who cannot join
- incapability of doing sports
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Institute of Sportsmedicine
Hanover, Lower Saxony, 30625
Hauke Horstmann, 0049 - 511 - 532 - 5499
Hauke Horstmann
About this study
Official title: Längsschnittstudie Zur Belastungsinduzierten Anpassung, Schädigung Oder Degeneration Der Schulter Bei Rollstuhlathleten/-Innen
The studies object is to evaluate the degeneration of overhead sports in wheelchair-using athletes. It is assumed that wheelchair users do have more symptomatic shoulder pain compared to non disabled athletes.
Read the detailed description
The force on the shoulder joint is high in handicapped people that are using wheelchairs. The prevalence of chronic shoulder pain for wheelchair-users is as high as 50-80%. Especially paraplegia developed in adult years is predisposed for shoulder pain. The reason is in the short adaption time of the tissue. Dysbalance musculature at the shoulder joint conveys chronic pain. The risk of chronic shoulder pain is rising for wheelchair-users, caused by the lack of recovery-time. After exercising wheelchair users depend on their shoulders in order to manage their daily living. The request of this study is to identify the determinants of shoulder pathologies. Precocious findings in pathologic changes of MRI scans, muscular dysbalance, clinical tests and/or ultrasound-scans lead to certain conclusions. The results should be used to get long-term disorder free situations for sportive wheelchair users.
Scientific background: International publications show relatively uniform results. Paraplegic people and non disabled high performance athletes in overhead sports show cumulative pathologic findings in MRI scans. There is only a minor correlation between MRI findings and clinical symptoms. It is not known how heavy the impact of MRI findings to develop a long term disorder of the shoulder of wheelchair users is. Isokinetic power measurement is a adequate examination of paraplegic people to evaluate the function of the shoulder.
Findings in non disabled high performance athletes: 40% of the asymptomatic high performance athletes in overhead sports show pathologies of their rotator cuff in the dominant arm in MRI (0% in the non dominant arm) (Connor et al. 2003). 10 asymptomatic College Baseball player went through clinical and MRI examination (Halbrecht et al. 1999). It showed pathologic findings the rotator cuff of the dominant side in 7 out of 10 cases. The findings in MRI correlated neither to symptoms nor to the level of instability.
30 asymptomatic athletes out of 52 long distance kayakers were examined with shoulder MRI (Hagemann et al. 2004). 13 asymptomatic kayaker showed pathologic findings in MRI. The authors concluded, that objective MRI findings and subjective discomfort is not highly correlated.
30 high performance handball players showed low correlation between MRI findings and clinical symptoms (Jost et al. 2005). 93% did have pathologic MRI findings, but only 37% were symptomatic.
These studies eliminate, that the clinical symptoms and the subjective impressions, which come up in the career of athletes are not well diagnosed by MRI. Statements about long term effects of rotator cuff tears can not be made. Kelly et al. provided evidence of rotator cuff tears in MRI of 12 non sportive people. 6 of them were symptomatic, 6 were not symptomatic. The subjects that were symptomatic showed lower activation of M. suprascapularis and higher activation of M. trapezius, M. supraspinatus and infraspinatus in EMG diagnosis. In spite of comparable MRI results asymptomatic subjects showed different patterns of innervation of the rotator cuff, than symptomatic subjects. This could lead to a development of muscular dysbalance or longterm defects in the asymptomatic patient. 14 Baseball players, who had no shoulder injury at their shoulder, got MRI scans (Miniaci et al. 2002). 22 of the 28 examined shoulders showed pathologic findings at the labrum. 10 of these athletes were asymptomatic. This is another example of the considerable difference in the felt discomfort and the MRI findings. This statement is not focusing on long term disorders.
MRI examinations in paraplegics: Escobedo et al. did a study in which they examined 26 symptomatic paraplegics with MRI scans on their shoulders. The MRI findings were compared with 17 non disabled subjects, who had symptomatic shoulders as well (Escobedo et al. 1997). 73% of the symptomatic paraplegics (59% of the non disabled) showed rotator cuff tears or following disorders in the MRI scan. 38% of the injured were multiple disorders.
Boninger et al. compared the force input on the wheelchair with MRI findings in 14 paraplegics, who were in average 33 years old. The subjects were asymptomatic and without previous shoulder injuries (Boninger et al. 2003). In intervals of 2 years MRI scans were made. The subjects participated in the study in average 10 years after injury of the spine.
- Conditions
- Degeneration, Shoulder Pain
- Keywords
- shoulder, strength, quality of life
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sportive wheelchair users | Not described | |
| sportive non disabled | Not described | |
| non sportive wheelchair users | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum strength measured in isokinetic power measurement
Measured: 2 hours
Secondary outcomes (1)
questionnaire: wheelchair users pain index and constant score
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DegenerationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263184
- Sponsor's protocol ID
- 5442 - Az 070402/0911
- Acronym
- Sodisow
- Status last verified
- Nov 2010
- First submitted
- 17 Dec 2010
- Last updated
- 29 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Längsschnittstudie Zur Belastungsinduzierten Anpassung, Schädigung Oder Degeneration Der Schulter Bei Rollstuhlathleten/-Innen
- ClinicalTrials.gov ID
- NCT01263184
- Acronym / sponsor ID
- Sodisow / 5442 - Az 070402/0911
- Conditions
- Degeneration, Shoulder Pain
- Keywords
- shoulder, strength, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Nov 2009
- First posted
- 20 Dec 2010 (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.
The studies object is to evaluate the degeneration of overhead sports in wheelchair-using athletes. It is assumed that wheelchair users do have more symptomatic shoulder pain compared to non disabled athletes.
Detailed description
The force on the shoulder joint is high in handicapped people that are using wheelchairs. The prevalence of chronic shoulder pain for wheelchair-users is as high as 50-80%. Especially paraplegia developed in adult years is predisposed for shoulder pain. The reason is in the short adaption time of the tissue. Dysbalance musculature at the shoulder joint conveys chronic pain. The risk of chronic shoulder pain is rising for wheelchair-users, caused by the lack of recovery-time. After exercising wheelchair users depend on their shoulders in order to manage their daily living. The request of this study is to identify the determinants of shoulder pathologies. Precocious findings in pathologic changes of MRI scans, muscular dysbalance, clinical tests and/or ultrasound-scans lead to certain conclusions. The results should be used to get long-term disorder free situations for sportive wheelchair users.
Scientific background: International publications show relatively uniform results. Paraplegic people and non disabled high performance athletes in overhead sports show cumulative pathologic findings in MRI scans. There is only a minor correlation between MRI findings and clinical symptoms. It is not known how heavy the impact of MRI findings to develop a long term disorder of the shoulder of wheelchair users is. Isokinetic power measurement is a adequate examination of paraplegic people to evaluate the function of the shoulder.
Findings in non disabled high performance athletes: 40% of the asymptomatic high performance athletes in overhead sports show pathologies of their rotator cuff in the dominant arm in MRI (0% in the non dominant arm) (Connor et al. 2003). 10 asymptomatic College Baseball player went through clinical and MRI examination (Halbrecht et al. 1999). It showed pathologic findings the rotator cuff of the dominant side in 7 out of 10 cases. The findings in MRI correlated neither to symptoms nor to the level of instability.
30 asymptomatic athletes out of 52 long distance kayakers were examined with shoulder MRI (Hagemann et al. 2004). 13 asymptomatic kayaker showed pathologic findings in MRI. The authors concluded, that objective MRI findings and subjective discomfort is not highly correlated.
30 high performance handball players showed low correlation between MRI findings and clinical symptoms (Jost et al. 2005). 93% did have pathologic MRI findings, but only 37% were symptomatic.
These studies eliminate, that the clinical symptoms and the subjective impressions, which come up in the career of athletes are not well diagnosed by MRI. Statements about long term effects of rotator cuff tears can not be made. Kelly et al. provided evidence of rotator cuff tears in MRI of 12 non sportive people. 6 of them were symptomatic, 6 were not symptomatic. The subjects that were symptomatic showed lower activation of M. suprascapularis and higher activation of M. trapezius, M. supraspinatus and infraspinatus in EMG diagnosis. In spite of comparable MRI results asymptomatic subjects showed different patterns of innervation of the rotator cuff, than symptomatic subjects. This could lead to a development of muscular dysbalance or longterm defects in the asymptomatic patient. 14 Baseball players, who had no shoulder injury at their shoulder, got MRI scans (Miniaci et al. 2002). 22 of the 28 examined shoulders showed pathologic findings at the labrum. 10 of these athletes were asymptomatic. This is another example of the considerable difference in the felt discomfort and the MRI findings. This statement is not focusing on long term disorders.
MRI examinations in paraplegics: Escobedo et al. did a study in which they examined 26 symptomatic paraplegics with MRI scans on their shoulders. The MRI findings were compared with 17 non disabled subjects, who had symptomatic shoulders as well (Escobedo et al. 1997). 73% of the symptomatic paraplegics (59% of the non disabled) showed rotator cuff tears or following disorders in the MRI scan. 38% of the injured were multiple disorders.
Boninger et al. compared the force input on the wheelchair with MRI findings in 14 paraplegics, who were in average 33 years old. The subjects were asymptomatic and without previous shoulder injuries (Boninger et al. 2003). In intervals of 2 years MRI scans were made. The subjects participated in the study in average 10 years after injury of the spine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sportive wheelchair users | – | – |
| sportive non disabled | – | – |
| non sportive wheelchair users | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- wheelchair users, sportiv people
Key inclusion criteria (1 listed)
- capability of doing sports
Key exclusion criteria (1 listed)
- incapability of doing sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum strength measured in isokinetic power measurement
Time frame: 2 hours
1 secondary outcome
questionnaire: wheelchair users pain index and constant score
Time frame: 15 Minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration and Shoulder Pain, run by Hannover Medical School at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 29 Dec 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hauke Horstmann (0049 - 511 - 532 - 5499, horstmann.hauke@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum strength measured in isokinetic power measurement (time frame: 2 hours). 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 29 Dec 2010.