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
  Purpose

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 Intervention Phase
Tendinopathy
Adrenal Insufficiency
Drug: methylprednisolone acetate
Drug: Triamcinolone Acetonide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Enrollment: 44
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652495

Locations
Italy
Rizzoli Orthopaedic Institute
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: Milva Battaglia, MD Istituti Ortopedici Rizzoli
  More Information

Additional Information:
Publications:
Responsible Party: milva.battaglia, Clinician, Principal Investigator, Department of Radiology, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01652495     History of Changes
Other Study ID Numbers: 2012-000866-40
Study First Received: July 21, 2012
Results First Received: March 22, 2014
Last Updated: August 23, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Istituto Ortopedico Rizzoli:
rotatory cuff calcific tendonitis
corticosteroids
US guided percutaneous treatment
methylprednisolone
triamcinolone
hypothalamus pituitary adrenal axis

Additional relevant MeSH terms:
Adrenal Insufficiency
Tendinopathy
Adrenal Gland Diseases
Endocrine System Diseases
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Methylprednisolone acetate
Prednisolone acetate
Triamcinolone hexacetonide
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Triamcinolone
Triamcinolone Acetonide
Prednisolone hemisuccinate
Prednisolone phosphate
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on September 14, 2014