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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01652495
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Azienda Ospedaliera San Giovanni Battista
Information provided by (Responsible Party):
milva.battaglia, Istituto Ortopedico Rizzoli

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tendinopathy Adrenal Insufficiency Drug: methylprednisolone acetate Drug: Triamcinolone Acetonide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy
Study Start Date : March 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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 Name: 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 Name: Triamvirgi

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01652495

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Rizzoli Orthopaedic Institute
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Azienda Ospedaliera San Giovanni Battista
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Principal Investigator: Milva Battaglia, MD Istituti Ortopedici Rizzoli
Additional Information:
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Responsible Party: milva.battaglia, Clinician, Principal Investigator, Department of Radiology, Istituto Ortopedico Rizzoli Identifier: NCT01652495    
Other Study ID Numbers: 2012-000866-40
First Posted: July 30, 2012    Key Record Dates
Results First Posted: September 1, 2014
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by milva.battaglia, Istituto Ortopedico Rizzoli:
rotatory cuff calcific tendonitis
US guided percutaneous treatment
hypothalamus pituitary adrenal axis
Additional relevant MeSH terms:
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Pituitary Diseases
Adrenal Insufficiency
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Adrenal Gland Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Triamcinolone Acetonide
Triamcinolone hexacetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents