Study of the Effect of Neck Treatment on Shoulder Impingement
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 1, 2008 | ||||
| Last Updated Date | July 15, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Active Shoulder Scaption range of motion [ Time Frame: 3 weeks, 6 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00764764 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
DASH Functional Questionaire [ Time Frame: 3 weeks, 6 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of the Effect of Neck Treatment on Shoulder Impingement | ||||
| Official Title ICMJE | Shoulder Impingement: A By-Product of Cervical Spine Dysfunction? | ||||
| Brief Summary | The purpose of this pilot study is to conduct research to determine the most effective physical therapy treatment for a condition called shoulder impingement. This condition occurs when tissue in the shoulder is caught between the humerus (arm bone) and the scapula (shoulder blade). This causes pain when one tries to reach overhead or behind the back. Two treatment methods will be used in the study. The first method uses the traditional treatments of hands-on shoulder stretching, shoulder exercise, posture, and education. The second method will use the traditional methods of shoulder treatment in addition to treatment of the cervical spine. It is hypothesized that a group of patients between 40 and 70 years of age with signs and symptoms of shoulder impingement who receive physical therapy to the cervical spine and shoulder will report a higher level of functioning, will report less pain, and will gain more range of motion than a group of patients receiving physical therapy solely to the shoulder. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 40 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00764764 | ||||
| Other Study ID Numbers ICMJE | 08-01-2014 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Clark Vaughan, CAMC | ||||
| Study Sponsor ICMJE | CAMC Health System | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | CAMC Health System | ||||
| Verification Date | July 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||