Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (TPESP2011-12)

August 23, 2014 updated by: milva.battaglia, Istituto Ortopedico Rizzoli

Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy

The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rotator cuff calcific tendonitis is a common disease, mainly affecting women aged 30 to 50 years old. It is associated to severe pain and impotence. US-guided percutaneous treatment is considered the gold standard treatment with the aim to destroy and wash out shoulder's calcification, responsible for inflammation, pain and functional limitation. Corticosteroids are injected in the subacromial-subdeltoid bursa at the end of the procedure to facilitate the prompt pain relief and functional recovery. Although corticosteroids represent the most powerful drugs to reduce inflammation and pain, their use is associated to important side effects, mainly the suppression of the hypothalamus-pituitary-axis (HPA). At the same time, no standardized protocols exist regarding the best type and dose of corticosteroid to be injected in association to the above mentioned treatment, nor data evaluating the exact duration of HPA suppression following a single intrabursal injection of corticosteroids.

40 patients affected by rotator cuff calcific tendonitis will be enrolled in the study and randomly assigned to two groups: one group (20 patients) will be treated with a single intrabursal injection of 40 mg of methylprednisolone; the other group (20 patients) will be treated with a single intrabursal injection of 40 mg of triamcinolone.

All patients will be tested at time 0 (morning before treatment) and at 1, 7, 15, 30 and 45 days after the injection, using clinical, laboratory and US parameters in order to compare the efficacy and safety of the two drugs.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Rizzoli Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • painful rotator cuff calcific tendonitis demonstrated by ultrasounds

Exclusion Criteria:

  • pregnancy
  • use of corticosteroids in the previous 2 months
  • systemic chronic inflammatory or allergic diseases
  • allergy to methylprednisolone or triamcinolone
  • diabetes
  • glaucoma
  • coagulopathies or current treatment with antiaggregants or anticoagulants
  • septic arthritis or infections
  • calcific enthesopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: methylprednisolone acetate group
Single intrabursal injection of methylprednisolone acetate
Drug: methylprednisolone acetate
Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate
Other Names:
  • Depo-medrol
Active Comparator: Triamcinolone acetonide group
Single intrabursal injection of Triamcinolone acetonide
Drug: Triamcinolone Acetonide
Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide
Other Names:
  • Triamvirgi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Improvement Measured According to Percentage Change in Constant Score
Time Frame: 180 days after treatment

Patients will be evaluated clinically by Constant Score

Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements

Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
180 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis
Time Frame: 45 days after treatment

Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays

Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values
45 days after treatment
Reduction of Pain Severity Expressed as Percentage Change in VAS Score
Time Frame: 180 days after treatment

VAS score

VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients

Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148.
180 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Collaborators

Azienda Ospedaliera San Giovanni Battista

Investigators

  • Principal Investigator: Milva Battaglia, MD, Istituti Ortopedici Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 21, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 23, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-000866-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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