Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01263184
Other study ID # 5442 - Az 070402/0911
Secondary ID
Status Recruiting
Phase N/A
First received December 17, 2010
Last updated December 28, 2010
Start date November 2009

Study information

Verified date November 2010
Source Hannover Medical School
Contact Hauke Horstmann
Phone 0049 - 511 - 532 - 5499
Email horstmann.hauke@mh-hannover.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- capability of doing sports

Exclusion Criteria:

- incapability of doing sports

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Institute of Sportsmedicine Hannover Lower Saxony

Sponsors (1)

Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum strength measured in isokinetic power measurement 2 hours No
Secondary questionnaire: wheelchair users pain index and constant score 15 Minutes No
See also
  Status Clinical Trial Phase
Recruiting NCT04930393 - Evaluating the Efficacy of PECS II Block Versus Axillary Ring Block in Rotator Cuff Repair Patients N/A
Completed NCT03717753 - Rotator Cuff Pathway N/A
Completed NCT04454671 - Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment N/A
Completed NCT06274827 - Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises N/A
Not yet recruiting NCT05413213 - Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder N/A
Not yet recruiting NCT05043844 - Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder N/A
Recruiting NCT02903719 - The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection. Phase 4
Completed NCT02554968 - Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02242630 - Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis N/A
Active, not recruiting NCT02843269 - Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM N/A
Completed NCT02631395 - The Effect of a Shoulder Training Program to Prevent Shoulder Pain Among Girls in Junior Team Handball N/A
Completed NCT01733914 - Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain Phase 2
Completed NCT01885377 - SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain N/A
Completed NCT01205542 - Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function N/A
Completed NCT01843660 - An Efficacy and Safety Study of Tramadol Hydrochloride-Paracetamol in Treatment of Moderate to Severe Acute Neck-Shoulder Pain and Low Back Pain Phase 4
Completed NCT00743600 - Ultrasound Evaluation of the Rotator Cable and Associated Structures. N/A
Completed NCT00679887 - Chronic Shoulder Pain Treated by Pressures With the Thumbs on the Trigger Points Phase 1/Phase 2
Completed NCT04058522 - Treatment of Subacromial Shoulder Pain by Individual or Group Physiotherapy Following Corticosteroid Injection N/A
Completed NCT03353272 - The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain N/A