ClinicalTrials.Veeva

Menu

An RCT in Treatment of Adhesive Capsulitis Arthrographic Joint Distention With Local Anesthetic Alone

Q

Queen's University

Status and phase

Completed
Phase 4

Conditions

Adhesive Capsulitis

Treatments

Other: Lidocaine
Drug: Triamcinalone (steroid) and lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02001740
SURG-246-12

Details and patient eligibility

About

Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.

Enrollment

108 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age range 19-70
  • Female and male
  • Ability to understand and give consent
  • Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.

Exclusion criteria

  • • Frozen shoulder secondary to trauma

    • Previous surgery on the affected shoulder
    • Age less than 19 or greater than 70
    • Systemic inflammatory joint disease such as Rheumatoid Arthritis
    • Radiographic evidence of osteoarthritis of the shoulder
    • Allergy to contrast material
    • Pregnant or breastfeeding women

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

108 participants in 2 patient groups, including a placebo group

lidocaine
Placebo Comparator group
Description:
frequency = once
Treatment:
Other: Lidocaine
Triamcinalone (steroid) and lidocaine
Experimental group
Description:
frequency = once
Treatment:
Drug: Triamcinalone (steroid) and lidocaine

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems