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| Name | Class |
|---|---|
| Azienda Ospedaliera San Giovanni Battista | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone acetate group | Active Comparator | Single intrabursal injection of methylprednisolone acetate |
|
| Triamcinolone acetonide group | Active Comparator | Single intrabursal injection of Triamcinolone acetonide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone acetate | Drug | Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milva Battaglia, MD | Istituti Ortopedici Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19561254 | Background | 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. | |
| 10797220 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylprednisolone Acetate Group | Single intrabursal injection of methylprednisolone acetate methylprednisolone acetate: Single intrabursal ultrasound guided injection |
| FG001 | Triamcinolone Acetonide Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Triamcinolone Acetonide | Drug | Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide |
|
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| 45 days after treatment |
| 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 |
| 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. |
| 10517721 | 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. |
| 85870 | 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. |
| 15751089 | 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. |
| 17596769 | 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. |
Single intrabursal injection of Triamcinolone acetonide
Triamcinolone Acetonide: Single intrabursal ultrasound guided injection
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylprednisolone Acetate | Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate |
| BG001 | Triamcinolone Acetonide | Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | percentage of improvement Constant score | 180 days after treatment |
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| |||||||||||||||||||||||||||||
| 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 | Posted | Number | % of patients with HPA suppression | 45 days after treatment |
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| |||||||||||||||||||||||||||||||
| 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. | Posted | Mean | 95% Confidence Interval | percentage of pain reduction | 180 days after treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylprednisolone Acetate Group | Single intrabursal injection of methylprednisolone acetate methylprednisolone acetate: Single intrabursal ultrasound guided injection | 0 | 20 | 0 | 20 | ||
| EG001 | Triamcinolone Acetonide Group | Single intrabursal injection of Triamcinolone acetonide Triamcinolone Acetonide: Single intrabursal ultrasound guided injection | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Milva Battaglia, Director of Clinical Trials | Istituto Ortopedico Rizzoli | 0516366026 | 0039 | milva.battaglia@ior.it |
| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077555 | Methylprednisolone Acetate |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014221 | Triamcinolone |
| D013259 | Steroids, Fluorinated |
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| >=65 years |
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| Male |
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