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

This study has been withdrawn prior to enrollment.
(difficulties in the department)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914836
First Posted: June 5, 2009
Last Update Posted: June 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HaEmek Medical Center, Israel
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914836


Locations
Israel
Haemek Medical Center
Afula, Israel
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
First Submitted: May 17, 2009
First Posted: June 5, 2009
Last Update Posted: June 23, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Tendinopathy
Bursitis
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Joint Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents