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

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliera San Giovanni Battista
Information provided by (Responsible Party):
milva.battaglia, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01652495
First received: July 21, 2012
Last updated: August 23, 2014
Last verified: August 2014

July 21, 2012
August 23, 2014
March 2012
May 2013   (final data collection date for primary outcome measure)
Functional Improvement Measured According to Percentage Change in Constant Score [ Time Frame: 180 days after treatment ] [ Designated as safety issue: No ]

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.

Degree of functional improvement [ Time Frame: 0, 1, 7, 15, 30 and 45 days after treatment ] [ Designated as safety issue: No ]
Patients will be evaluated clinically (VAS and Constants scores) and by ultrasonography (residual calcification and bursa thickness)
Complete list of historical versions of study NCT01652495 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis [ Time Frame: 45 days after treatment ] [ Designated as safety issue: Yes ]

    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

  • Reduction of Pain Severity Expressed as Percentage Change in VAS Score [ Time Frame: 180 days after treatment ] [ Designated as safety issue: No ]

    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.

Suppression of hypothalamus-pituitary-adrenal axis [ Time Frame: 0, 1,7, 15, 30 and 45 days after treatment ] [ Designated as safety issue: Yes ]
Evaluation of blood cortisol and ACTH, urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays
Not Provided
Not Provided
 
Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Tendinopathy
  • Adrenal Insufficiency
  • Drug: methylprednisolone acetate
    Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate
    Other Name: Depo-medrol
  • Drug: Triamcinolone Acetonide
    Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide
    Other Name: Triamvirgi
  • Active Comparator: methylprednisolone acetate group
    Single intrabursal injection of methylprednisolone acetate
    Intervention: Drug: methylprednisolone acetate
  • Active Comparator: Triamcinolone acetonide group
    Single intrabursal injection of Triamcinolone acetonide
    Intervention: Drug: Triamcinolone Acetonide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01652495
2012-000866-40
No
milva.battaglia, Istituto Ortopedico Rizzoli
Istituto Ortopedico Rizzoli
Azienda Ospedaliera San Giovanni Battista
Principal Investigator: Milva Battaglia, MD Istituti Ortopedici Rizzoli
Istituto Ortopedico Rizzoli
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP