NCT03013205

Brief Summary

Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

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

December 26, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

December 26, 2016

Last Update Submit

January 5, 2017

Conditions

Direct Coracohumeral Ligament Steroid Injection

Keywords

adhesive capsulitis

Outcome Measures

Primary Outcomes (1)

  • Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement

    shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100

    2 years

Secondary Outcomes (3)

  • Change of Visual analogue scale

    2 years

  • Shoulder range of motion improvement

    2 years

  • Stiffness of coracohumeral ligament under elastogram (KPa)

    2 years

Study Arms (2)

PT+IA+CHL

EXPERIMENTAL

1. Intraarticular triamcinolone injection 2. Intraarticular Xylocaine injection 3. Coracohumeral ligament triamcinolone injection 4. Physiotherapy

Procedure: Intraarticular triamcinolone injectionProcedure: Intraarticular Xylocaine injectionProcedure: Coracohumeral ligament triamcinolone injectionProcedure: Physiotherapy

PT+IA

ACTIVE COMPARATOR

1. Intraarticular triamcinolone injection 2. Intraarticular Xylocaine injection 3. Physiotherapy

Procedure: Intraarticular triamcinolone injectionProcedure: Intraarticular Xylocaine injectionProcedure: Physiotherapy

Interventions

Intraarticular triamcinolone injectionPROCEDURE

triamcinolone 10mg/mL

PT+IAPT+IA+CHL
Intraarticular Xylocaine injectionPROCEDURE

Xylocaine 1% 4ml

PT+IAPT+IA+CHL
Coracohumeral ligament triamcinolone injectionPROCEDURE

triamcinolone 10mg/mL

PT+IA+CHL
PhysiotherapyPROCEDURE
PT+IAPT+IA+CHL

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-80 years old
  • Unilateral shoulder pain more than 3 months
  • At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)
  • Visual analog scale more than 30 (total 100)
  • No fracture or subluxation or arthritis in shoulder Xray.

You may not qualify if:

  • History of shoulder or chest surgery
  • History of shoulder trauma in 2 recent years
  • Ever receiving shoulder joint injection in recent 3 months
  • With cervical radiculopathy or any central CNS disorders
  • With osteoarthritis or rheumatic arthritis of shoulder
  • Diagnosed as rotator cuff tear, tendon calcification or bursitis
  • Systemic diseases including diabetes or thyroid disorder
  • Allergy history of steroid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Test1, Test2, test3, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Chueh-Hung Wu, MD

    NTUH PMR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chueh-Hung Wu

CONTACT

0972651208nojred@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2016

First Posted

January 6, 2017

Study Start

February 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

TW(1)