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Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

NCT ID: NCT00840229

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

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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

Detailed Description

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

Conditions

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Adhesive Capsulitis

Keywords

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adhesive capsulitis corticosteroids injection pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1 capsular & intra-articular

corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular

Group Type EXPERIMENTAL

Triamcinolone hexacetonide

Intervention Type DRUG

1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml

2 intra-articular

corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule

Group Type ACTIVE_COMPARATOR

Triamcinolone hexacetonide

Intervention Type DRUG

1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml

3 placebo

placebo injections (Lidocaine) in capsule and intra-articular

Group Type PLACEBO_COMPARATOR

Triamcinolone hexacetonide

Intervention Type DRUG

20 mg

Interventions

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Triamcinolone hexacetonide

20 mg

Intervention Type DRUG

Triamcinolone hexacetonide

1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tore Prestegaard

MD, consultant physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tore A Prestgaard, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital of Vestfold

Locations

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Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation

Stavern, , Norway

Site Status

Countries

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Norway

References

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Prestgaard T, Wormgoor MEA, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015 Sep;156(9):1683-1691. doi: 10.1097/j.pain.0000000000000209.

Reference Type DERIVED
PMID: 25919473 (View on PubMed)

Other Identifiers

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REK

Identifier Type: REGISTRY

Identifier Source: secondary_id

Interne tjenester

Identifier Type: OTHER

Identifier Source: secondary_id

IT-avdelingen

Identifier Type: OTHER

Identifier Source: secondary_id

Rikshospitalet HF

Identifier Type: OTHER

Identifier Source: secondary_id

S-08546

Identifier Type: -

Identifier Source: org_study_id