Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids Intrabursal Injection (TPESP2011-12)
|Tendinopathy Adrenal Insufficiency||Drug: methylprednisolone acetate Drug: Triamcinolone Acetonide||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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|
- 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.
- 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
- Reduction of Pain Severity Expressed as Percentage Change in VAS Score [ Time Frame: 180 days after treatment ]
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.
|Study Start Date:||March 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652495
|Rizzoli Orthopaedic Institute|
|Bologna, Italy, 40136|
|Principal Investigator:||Milva Battaglia, MD||Istituti Ortopedici Rizzoli|