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

NCT01652495 | Completed Phase 4 Results

• 1 other identifier: 2012-000866-40
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy; Adrenal Insufficiency

Keywords

rotatory cuff calcific tendonitis; corticosteroids; US guided percutaneous treatment; methylprednisolone; triamcinolone; hypothalamus pituitary adrenal axis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis

  45 days after treatment

• Reduction of Pain Severity Expressed as Percentage Change in VAS Score

  180 days after treatment

Study Arms (2)

methylprednisolone acetate group

ACTIVE COMPARATOR

Single intrabursal injection of methylprednisolone acetate

Drug: methylprednisolone acetate

Triamcinolone acetonide group

ACTIVE COMPARATOR

Single intrabursal injection of Triamcinolone acetonide

Drug: Triamcinolone Acetonide

Interventions

methylprednisolone acetate DRUG

Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate

Also known as: Depo-medrol

methylprednisolone acetate group

Triamcinolone Acetonide DRUG

Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide

Also known as: Triamvirgi

Triamcinolone acetonide group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• painful rotator cuff calcific tendonitis demonstrated by ultrasounds

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Azienda Ospedaliera San Giovanni Battista: collaborator

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Related Publications (6)

• 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.

  PMID: 19561254 BACKGROUND

• 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. doi: 10.5435/00124635-199707000-00001.

  PMID: 10797220 BACKGROUND

• Krasner AS. Glucocorticoid-induced adrenal insufficiency. JAMA. 1999 Aug 18;282(7):671-6. doi: 10.1001/jama.282.7.671. No abstract available.

  PMID: 10517721 BACKGROUND

• 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. doi: 10.1016/s0140-6736(79)91077-8.

  PMID: 85870 BACKGROUND

• 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. doi: 10.1002/art.20884.

  PMID: 15751089 BACKGROUND

• 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. doi: 10.1249/mss.0b013e31805468d6.

  PMID: 17596769 BACKGROUND

MeSH Terms

Conditions

Tendinopathy; Adrenal Insufficiency

Interventions

Methylprednisolone Acetate; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Triamcinolone; Steroids, Fluorinated

Results Point of Contact

• Title: Milva Battaglia, Director of Clinical Trials
• Organization: Istituto Ortopedico Rizzoli

milva.battaglia@ior.it

0516366026

Study Officials

• Milva Battaglia, MD

  Istituti Ortopedici Rizzoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician, Principal Investigator, Department of Radiology

Study Record Dates

• First Submitted: July 21, 2012
• First Posted: July 30, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 1, 2014
• Results First Posted: September 1, 2014

Record last verified: 2014-08

Locations

IT (1)