NCT00742846

Brief Summary

The primary objective is to compare the clinical outcomes of patients with a clinical diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid injections. The secondary objective is to verify that steroid injections in combination with physical therapy lead to more favorable outcomes than local anesthetic injections in combination with physical therapy.

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 Aug 2008

Typical duration 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withdrawn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

Study Start

First participant enrolled

August 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

August 26, 2008

Last Update Submit

February 25, 2015

Conditions

Adhesive Capsulitis

Keywords

Adhesive CapsulitisSubacromial injectionIntraarticular injection

Outcome Measures

Primary Outcomes (1)

  • The primary goal of this study is to document the return of shoulder motion and resolution of adhesive capsulitis after intra-articular versus subacromial steroid injections versus anesthetic injections in combination with physical therapy.

    6-8 months

Study Arms (4)

Group 1

ACTIVE COMPARATOR

The patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.

Drug: Lidocaine + Kenalog

Group 2

ACTIVE COMPARATOR

The patient receives subacromial steroid and local anesthetic injection under fluoroscopy.

Drug: Lidocaine + Kenalog

Group 3

ACTIVE COMPARATOR

The patient receives intra-articular local anesthetic injection under fluoroscopy.

Drug: Lidocaine

Group 4

ACTIVE COMPARATOR

The patient receives subacromial local anesthetic injection under fluoroscopy.

Drug: Lidocaine

Interventions

Lidocaine + KenalogDRUG

5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint Intra-articular injection with local anesthetic and steroid

Also known as: Kenalog, Lidocaine
Group 1
LidocaineDRUG

5ml 1% Lidocaine alone into the shoulder joint. intra-articular local anesthetic injection

Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet clinical diagnosis of primary Adhesive Capsulitis
  • Restriction in abduction to less than 130 degrees
  • % reduction in external rotation as compared with the contralateral side
  • An intact rotator cuff
  • Between 18-75 years of age

You may not qualify if:

  • Previous shoulder capsular surgery
  • History of steroid injection(s) into affected shoulder
  • Inability to provide informed consent
  • Iodinated contrast dye allergy
  • Allergy to lidocaine
  • Other suspected shoulder pathology (i.e., tumor, rotator cuff rupture. infection, arthritis)
  • Known bleeding diathesis
  • Cervical spine pathology
  • History of trauma to the shoulder
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (19)

  • Alvado A, Pelissier J, Benaim C, Petiot S, Herisson C. [Physical therapy of frozen shoulder: literature review]. Ann Readapt Med Phys. 2001 Mar;44(2):59-71. doi: 10.1016/s0168-6054(00)00062-3. French.

    PMID: 11587654BACKGROUND

  • Andrieu V, Dromer C, Fourcade D, Zabraniecki L, Ginesty E, Marc V, Railhac JJ, Fournie B. Adhesive capsulitis of the shoulder: therapeutic contribution of subacromial bursography. Rev Rhum Engl Ed. 1998 Dec;65(12):771-7.

    PMID: 9923046BACKGROUND

  • Arslan S, Celiker R. Comparison of the efficacy of local corticosteroid injection and physical therapy for the treatment of adhesive capsulitis. Rheumatol Int. 2001 Sep;21(1):20-3. doi: 10.1007/s002960100127.

    PMID: 11678298BACKGROUND

  • Bert J. Shoulder injections for subacromial bursitis. Minn Med. 1996 Sep;79(9):6. No abstract available.

    PMID: 8854664BACKGROUND

  • Carette S, Moffet H, Tardif J, Bessette L, Morin F, Fremont P, Bykerk V, Thorne C, Bell M, Bensen W, Blanchette C. Intraarticular corticosteroids, supervised physiotherapy, or a combination of the two in the treatment of adhesive capsulitis of the shoulder: a placebo-controlled trial. Arthritis Rheum. 2003 Mar;48(3):829-38. doi: 10.1002/art.10954.

    PMID: 12632439BACKGROUND

  • Chen MJ, Lew HL, Hsu TC, Tsai WC, Lin WC, Tang SF, Lee YC, Hsu RC, Chen CP. Ultrasound-guided shoulder injections in the treatment of subacromial bursitis. Am J Phys Med Rehabil. 2006 Jan;85(1):31-5. doi: 10.1097/01.phm.0000184158.85689.5e.

    PMID: 16357546BACKGROUND

  • Dacre JE, Beeney N, Scott DL. Injections and physiotherapy for the painful stiff shoulder. Ann Rheum Dis. 1989 Apr;48(4):322-5. doi: 10.1136/ard.48.4.322.

    PMID: 2712613BACKGROUND

  • Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.

    PMID: 16356983BACKGROUND

  • Fouquet B, Griffoul I, Borie MJ, Roger R, Bonnin B, Metivier JC, Pellieux S. [Adhesive capsulitis: evaluation of a treatment coupling capsular distension and intensive rehabilitation]. Ann Readapt Med Phys. 2006 Mar;49(2):68-74. doi: 10.1016/j.annrmp.2005.09.001. Epub 2005 Sep 27. French.

    PMID: 16229920BACKGROUND

  • de Jong BA, Dahmen R, Hogeweg JA, Marti RK. Intra-articular triamcinolone acetonide injection in patients with capsulitis of the shoulder: a comparative study of two dose regimens. Clin Rehabil. 1998 Jun;12(3):211-5. doi: 10.1191/026921598673772420.

    PMID: 9688036BACKGROUND

  • Hollingworth GR, Ellis RM, Hattersley TS. Comparison of injection techniques for shoulder pain: results of a double blind, randomised study. Br Med J (Clin Res Ed). 1983 Nov 5;287(6402):1339-41. doi: 10.1136/bmj.287.6402.1339.

    PMID: 6416401BACKGROUND

  • Kivimaki J, Pohjolainen T. Manipulation under anesthesia for frozen shoulder with and without steroid injection. Arch Phys Med Rehabil. 2001 Sep;82(9):1188-90. doi: 10.1053/apmr.2001.24169.

    PMID: 11552189BACKGROUND

  • Loyd JA, Loyd HM. Adhesive capsulitis of the shoulder: arthrographic diagnosis and treatment. South Med J. 1983 Jul;76(7):879-83. doi: 10.1097/00007611-198307000-00016.

    PMID: 6867799BACKGROUND

  • Parlier-Cuau C, Champsaur P, Nizard R, Wybier M, Bacque MC, Laredo JD. Percutaneous treatments of painful shoulder. Radiol Clin North Am. 1998 May;36(3):589-96. doi: 10.1016/s0033-8389(05)70047-6.

    PMID: 9597076BACKGROUND

  • Richardson AT. Ernest Fletcher Lecture. The painful shoulder. Proc R Soc Med. 1975 Nov;68(11):731-6. doi: 10.1177/003591577506801137. No abstract available.

    PMID: 53845BACKGROUND

  • Rizk TE, Pinals RS, Talaiver AS. Corticosteroid injections in adhesive capsulitis: investigation of their value and site. Arch Phys Med Rehabil. 1991 Jan;72(1):20-2.

    PMID: 1985618BACKGROUND

  • Ryans I, Montgomery A, Galway R, Kernohan WG, McKane R. A randomized controlled trial of intra-articular triamcinolone and/or physiotherapy in shoulder capsulitis. Rheumatology (Oxford). 2005 Apr;44(4):529-35. doi: 10.1093/rheumatology/keh535. Epub 2005 Jan 18.

    PMID: 15657070BACKGROUND

  • Tallia AF, Cardone DA. Diagnostic and therapeutic injection of the shoulder region. Am Fam Physician. 2003 Mar 15;67(6):1271-8.

    PMID: 12674455BACKGROUND

  • White, AET, Tuite, J.D. The accuracy and efficacy of shoulder injections in restrictive capsulitis. Journal of Orthopaedic Rheumatology 1996; 9: 37-40.

    BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

LidocaineTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • April Armstrong, MD

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations

US(1)