Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by HaEmek Medical Center, Israel.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00914836
First received: May 17, 2009
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.


Condition Intervention
Tendonitis
Bursitis
Drug: Betamethasone Sodium Phosphate
Drug: 1 cc - Betamethasone Sodium Phosphate
Drug: 2 cc - Betamethasone Sodium Phosphate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • constant score [ Time Frame: 9 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 cc - Betamethasone Sodium Phosphate
1 cc - Betamethasone Sodium Phosphate
Drug: Betamethasone Sodium Phosphate
1cc:2cc
Other Name: diprospan
Drug: 1 cc - Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate
Other Name: diprospan
Active Comparator: 2 cc - Betamethasone Sodium Phosphate
2 cc - Betamethasone Sodium Phosphate
Drug: Betamethasone Sodium Phosphate
1cc:2cc
Other Name: diprospan
Drug: 2 cc - Betamethasone Sodium Phosphate
Betamethasone Sodium Phosphate
Other Name: diprospan

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subacromial bursitis
  • tendinitis
  • Calcific Tendonitis

Exclusion Criteria:

  • rotator cuff tear
  • osteoarthritis
  • pregnancy
  • local or systemic infection
  • steroid or lidocaine sensitivity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914836

Contacts
Contact: avi chezar, M.D 972-4-6494300 chezarmd@gmail.com

Locations
Israel
Haemek Medical Center Not yet recruiting
Afula, Israel
Contact: avi chezar, M.D    972-4-6494300    chezarmd@gmail.com   
Principal Investigator: avi chezar, M.D         
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

Publications:
Responsible Party: orit semana, haemek medical center
ClinicalTrials.gov Identifier: NCT00914836     History of Changes
Other Study ID Numbers: 19-09
Study First Received: May 17, 2009
Last Updated: June 4, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
shoulder
subacromion
corticosteroid
bursitis
tendinitis
calcific tendonitis
subacromial bursitis
rotator cuff tendinitis

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Betamethasone sodium phosphate
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014