Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

This study has been completed.
Information provided by (Responsible Party):
Tore Prestegaard, Sykehuset i Vestfold HF Identifier:
First received: February 8, 2009
Last updated: November 24, 2013
Last verified: November 2013

The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.

Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).

0-hypothesis: no difference between the methods.

The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections

Condition Intervention
Adhesive Capsulitis
Drug: Triamcinolone hexacetonide

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Function (ROM, SPADI), Life quality [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 capsular & intra-articular
corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Active Comparator: 2 intra-articular
corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule
Drug: Triamcinolone hexacetonide
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
Placebo Comparator: 3 placebo
placebo injections (Lidocaine) in capsule and intra-articular
Drug: Triamcinolone hexacetonide
20 mg

Detailed Description:
3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pain and stiffness in one shoulder 1 - 6 months
  • Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder

Exclusion Criteria:

  • Systemic inflammatory disease
  • Corticosteroid treatment last 3 months
  • Poorly controlled Diabetes mellitus
  • Pregnancy
  • Contraindications/allergy to corticosteroids and/or Lidocaine
  • Severe infections
  • Osteoarthritis of the shoulder
  • Fractures of the shoulder
  • Rotator cuff pathology causing pain or disability
  • Fibromyalgia
  • Not able to understand Norwegian
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Please refer to this study by its identifier: NCT00840229

Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
Stavern, Norway, 3294
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Tore A Prestgaard, MD The Hospital of Vestfold
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tore Prestegaard, MD, consultant physician, Sykehuset i Vestfold HF Identifier: NCT00840229     History of Changes
Other Study ID Numbers: S-08546  REK  Interne tjenester  IT-avdelingen  Rikshospitalet HF 
Study First Received: February 8, 2009
Last Updated: November 24, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
adhesive capsulitis

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016