NCT00914836

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

10 months

First QC Date

May 17, 2009

Last Update Submit

June 21, 2015

Conditions

TendonitisBursitis

Keywords

shouldersubacromioncorticosteroidbursitistendinitiscalcific tendonitissubacromial bursitisrotator cuff tendinitis

Outcome Measures

Primary Outcomes (1)

  • constant score

    9 month

Study Arms (2)

1 cc - Betamethasone Sodium Phosphate

ACTIVE COMPARATOR

1 cc - Betamethasone Sodium Phosphate

Drug: Betamethasone Sodium PhosphateDrug: 1 cc - Betamethasone Sodium Phosphate

2 cc - Betamethasone Sodium Phosphate

ACTIVE COMPARATOR

2 cc - Betamethasone Sodium Phosphate

Drug: Betamethasone Sodium PhosphateDrug: 2 cc - Betamethasone Sodium Phosphate

Interventions

Betamethasone Sodium PhosphateDRUG

1cc:2cc

Also known as: diprospan
1 cc - Betamethasone Sodium Phosphate2 cc - Betamethasone Sodium Phosphate
1 cc - Betamethasone Sodium PhosphateDRUG

Betamethasone Sodium Phosphate

Also known as: diprospan
1 cc - Betamethasone Sodium Phosphate
2 cc - Betamethasone Sodium PhosphateDRUG

Betamethasone Sodium Phosphate

Also known as: diprospan
2 cc - Betamethasone Sodium Phosphate

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subacromial bursitis
  • tendinitis
  • Calcific Tendonitis

You may not qualify if:

  • rotator cuff tear
  • osteoarthritis
  • pregnancy
  • local or systemic infection
  • steroid or lidocaine sensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

Related Publications (1)

  • van der Heijden GJ, van der Windt DA, Kleijnen J, Koes BW, Bouter LM. Steroid injections for shoulder disorders: a systematic review of randomized clinical trials. Br J Gen Pract. 1996 May;46(406):309-16.

    PMID: 8762750BACKGROUND

MeSH Terms

Conditions

TendinopathyBursitisRotator Cuff Injuries

Interventions

betamethasone sodium phosphatebetamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesJoint DiseasesRuptureShoulder Injuries
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2009

First Posted

June 5, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

IL(1)