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Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT00840229
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Tore Prestegaard, Sykehuset i Vestfold HF

Brief Summary:

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 or disease Intervention/treatment Phase
Adhesive Capsulitis Drug: Triamcinolone hexacetonide Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 2-3 years ]

Secondary Outcome Measures :
  1. Function (ROM, SPADI), Life quality [ Time Frame: 2-3 years ]


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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840229


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tore Prestegaard, MD, consultant physician, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT00840229     History of Changes
Other Study ID Numbers: S-08546
REK ( Registry Identifier: S-08546 )
Interne tjenester ( Other Identifier )
IT-avdelingen ( Other Identifier: 2008/5000 )
Rikshospitalet HF ( Other Identifier )
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Tore Prestegaard, Sykehuset i Vestfold HF:
adhesive capsulitis
corticosteroids
injection
pain

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors