NCT01538758

Brief Summary

Ultrasound guided needling is becoming an accepted treatment for patients with shoulder pain due to calcifying tendinitis. However, evidence for this treatment is lacking. The investigators expect that patients treated with us guided needling with corticosteroid injection compared with patients treated with only corticosteroid injections in the subacromial bursa have better clinical outcome after one year follow-up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 30, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

November 30, 2011

Last Update Submit

July 11, 2012

Conditions

Calcific Tendinitis

Keywords

calcifying tendinitisrotator cuff

Outcome Measures

Primary Outcomes (2)

  • VAS score on long term

    1 year

  • Constant score on long term

    The constant score is a validated scale, measuring the shoulder function. It is a objective measurement independent of the shoulder pain.

    1 year

Secondary Outcomes (5)

  • Constant score

    baseline,6 weeks, 3 months and 6 months

  • VAS score

    Baseline, 2 weeks, 6 weeks, 3 months and 6 months

  • DASH score

    baseline, 6 weeks, 3 months, 6 months and 1 year.

  • Gärtner score of the shoulder calcifications on x-ray

    at baseline, directly post-interventional, at 6 weeks and one year.

  • Scoring system presented by Chiou et all. of the calcifications of the supraspinatus tendon on ultrasound

    at baseline, directly post-interventional, at 6 weeks and one year.

Study Arms (2)

Us guided needling

ACTIVE COMPARATOR

Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented. After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.

Other: Us guided needling

corticosteroid injection

ACTIVE COMPARATOR

Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.

Other: corticosteroid injection

Interventions

Us guided needlingOTHER

Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented. After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance.

Also known as: Barbotage
Us guided needling
corticosteroid injectionOTHER

Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.

corticosteroid injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shoulder pain without improvement after 3 months despite conservative treatment
  • Calcification on x-ray (Gartner type I of II) and ultrasound in the supraspinatus tendon less than 6 weeks before the treatment
  • All patients are first seen and included by the orthopaedic surgeon

You may not qualify if:

  • Previous operation of the shoulder
  • Previous ultrasound guided needling of the shoulder
  • Frozen shoulder
  • Last corticosteroid injection less than 3 months ago
  • Comorbidities of the painful shoulder on x-ray or ultrasound ( ruptured tendon, fracture, bursitis,...)
  • No informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente

Enschede, 7513 ER, Netherlands

RECRUITING

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Eva Genbrugge, MD

    MST

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Genbrugge, MD

CONTACT

+31 53 4 87 20 00eva_genbrugge@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 30, 2011

First Posted

February 24, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2014

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

NL(1)