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NCT Number: NCT00840229

Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder

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

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation

Stavern, 3294, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone hexacetonide

Drug

20 mg

Primary outcomes

  1. Pain reduction

    Time frame: 2-3 years

Secondary outcomes

  1. Function (ROM, SPADI), Life quality

    Time frame: 2-3 years

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 10, 2009
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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