Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection

Tendinopathy Clinical Trial

— TPESP2011-12  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652495
• Other study ID #: 2012-000866-40
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2012
• Last updated: August 23, 2014
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Tendinopathy

Intervention

Drug:
• methylprednisolone acetate
Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate
• Triamcinolone Acetonide
Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide

Locations

Country	Name	City	State
Italy	Rizzoli Orthopaedic Institute	Bologna

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli	Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Duclos M, Guinot M, Colsy M, Merle F, Baudot C, Corcuff JB, Lebouc Y. High risk of adrenal insufficiency after a single articular steroid injection in athletes. Med Sci Sports Exerc. 2007 Jul;39(7):1036-43. — View Citation

Krasner AS. Glucocorticoid-induced adrenal insufficiency. JAMA. 1999 Aug 18;282(7):671-6. — View Citation

Mader R, Lavi I, Luboshitzky R. Evaluation of the pituitary-adrenal axis function following single intraarticular injection of methylprednisolone. Arthritis Rheum. 2005 Mar;52(3):924-8. — View Citation

Serafini G, Sconfienza LM, Lacelli F, Silvestri E, Aliprandi A, Sardanelli F. Rotator cuff calcific tendonitis: short-term and 10-year outcomes after two-needle us-guided percutaneous treatment--nonrandomized controlled trial. Radiology. 2009 Jul;252(1):157-64. doi: 10.1148/radiol.2521081816. Erratum in: Radiology. 2010 Feb;254(2):636. — View Citation

Spiegel RJ, Vigersky RA, Oliff AI, Echelberger CK, Bruton J, Poplack DG. Adrenal suppression after short-term corticosteroid therapy. Lancet. 1979 Mar 24;1(8117):630-3. — View Citation

Uhthoff HK, Loehr JW. Calcific Tendinopathy of the Rotator Cuff: Pathogenesis, Diagnosis, and Management. J Am Acad Orthop Surg. 1997 Jul;5(4):183-191. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Improvement Measured According to Percentage Change in Constant Score	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	No
Secondary	Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis	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	Yes
Secondary	Reduction of Pain Severity Expressed as Percentage Change in VAS Score	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	No

External Links

•   Dr Battaglia's page on the website of Rizzoli Orthopedic Institute explaining her activity