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NCT Number: NCT01652495

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

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.

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Key information

Conditions

Tendinopathy Adrenal Gland Diseases Adrenal Insufficiency Endocrine System Diseases Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Acetate

Drug

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

Other names: Depo-medrol

Triamcinolone Acetonide

Drug

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

Other names: Triamvirgi

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Azienda Ospedaliera San Giovanni Battista

Registry information

Official study title

Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to a Single Intrabursal Injection of Corticosteroids in Patients With Shoulder Calcific Tendinopathy

Acronym: TPESP2011-12

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 30, 2012
Registry last updated
Sep 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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