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Adhesive CapsulitisNCT00742846

Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis

A study testing Lidocaine + Kenalog and Lidocaine in people with Adhesive Capsulitis, run by Milton S. Hershey Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adhesive Capsulitis
What is being tested?
Lidocaine + Kenalog and Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Aug 2008to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meet clinical diagnosis of primary Adhesive Capsulitis
  • Restriction in abduction to less than 130 degrees
  • 50% reduction in external rotation as compared with the contralateral side
  • An intact rotator cuff
  • Between 18-75 years of age

Who cannot join

  • 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)
Show all 10Show fewer
  • Known bleeding diathesis
  • Cervical spine pathology
  • History of trauma to the shoulder
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Read the detailed description

Current treatment for Adhesive Capsulitis involves physical therapy. Steroid injections have not been shown to be as effective alone without the physical therapy. However, there are multiple studies that document the benefit of adding a steroid injection to the physical therapy. After a review of the literature, there are studies that compare different dosages of intra-articular steroid injections,value and site of the injections, and accuracy of clinical injections. There are currently no studies that compare the results after intra-articular versus subacromial injections in combination with physical therapy. This study would help us determine if location of the injection is a major factor in regaining motion. If it is significantly important to be intra-articular with the steroid, than it may be important to send patients for fluoroscopic guided injections routinely rather than risk the chance of not being within the joint.

Being tested
Lidocaine + Kenalog, Lidocaine
Keywords
Adhesive Capsulitis, Subacromial injection, Intraarticular injection
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine + KenalogDrug

    Also called Kenalog, Lidocaine

    5ml 1% Lidocaine + 1ml 40mg Kenalog®-10 into the shoulder joint

    Intra-articular injection with local anesthetic and steroid

  • Lidocaine + KenalogDrug

    Also called Lidocaine, Kenalog

    5ml 1% Lidocaine + 1ml 40mg Kenalog-10 into the subacromial space

    Local anesthetic and steroid in to the subacromial space

  • LidocaineDrug

    5ml 1% Lidocaine alone into the shoulder joint.

    intra-articular local anesthetic injection

  • LidocaineDrug

    5ml 1% Lidocaine alone into the subacromial space.

    subacromial local anesthetic injection

Study groups in NCT00742846
Study groupRoleWhat they receive
Group 1Active comparatorThe patient receives intra-articular steroid and local anesthetic injection under fluoroscopy.
Receives: Drug: Lidocaine + Kenalog
Group 2Active comparatorThe patient receives subacromial steroid and local anesthetic injection under fluoroscopy.
Receives: Drug: Lidocaine + Kenalog
Group 3Active comparatorThe patient receives intra-articular local anesthetic injection under fluoroscopy.
Receives: Drug: Lidocaine
Group 4Active comparatorThe patient receives subacromial local anesthetic injection under fluoroscopy.
Receives: Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionDec 2010
  4. Study completionDec 2010

Why it stopped: No enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00742846
Sponsor's protocol ID
IRB #26378
Status last verified
Feb 2015
First submitted
26 Aug 2008
Last updated
27 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11587654

  • 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.

    PubMed 9923046

  • 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.

    PubMed 11678298

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

    PubMed 8854664

  • 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.

    PubMed 12632439

  • 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.

    PubMed 16357546

  • 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.

    PubMed 2712613

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

    PubMed 16356983

  • 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.

    PubMed 16229920

  • 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.

    PubMed 9688036

  • 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.

    PubMed 6416401

  • 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.

    PubMed 11552189

  • 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.

    PubMed 6867799

  • 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.

    PubMed 9597076

  • 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.

    PubMed 53845

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine + Kenalog and Lidocaine in people with Adhesive Capsulitis, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6-8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00742846, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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