Tendinopathy, Adrenal Insufficiency
Conditions
Keywords
rotatory cuff calcific tendonitis, corticosteroids, US guided percutaneous treatment, methylprednisolone, triamcinolone, hypothalamus pituitary adrenal axis
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.
Detailed 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.
Interventions
Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate
DRUGTriamcinolone Acetonide
Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide
Sponsors
Azienda Ospedaliera San Giovanni Battista
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement Measured According to Percentage Change in Constant Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis | 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 | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methylprednisolone Acetate Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate | 20 |
| Triamcinolone Acetonide Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Triamcinolone Acetonide | Methylprednisolone Acetate | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Continuous | 46.35 years STANDARD_DEVIATION 7.27 | 51.05 years STANDARD_DEVIATION 6.67 | 48.70 years STANDARD_DEVIATION 7.29 |
| Region of Enrollment Italy | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 8 Participants | 14 Participants | 22 Participants |
| Sex: Female, Male Male | 12 Participants | 6 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 180 days after treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Methylprednisolone Acetate Group | Functional Improvement Measured According to Percentage Change in Constant Score | 99 percentage of improvement Constant score |
| Triamcinolone Acetonide Group | Functional Improvement Measured According to Percentage Change in Constant Score | 95 percentage of improvement Constant score |
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
Time frame: 45 days after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Methylprednisolone Acetate Group | Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis | 0 % of patients with HPA suppression |
| Triamcinolone Acetonide Group | Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis | 15 % of patients with HPA suppression |
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.
Time frame: 180 days after treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Methylprednisolone Acetate Group | Reduction of Pain Severity Expressed as Percentage Change in VAS Score | 82 percentage of pain reduction |
| Triamcinolone Acetonide Group | Reduction of Pain Severity Expressed as Percentage Change in VAS Score | 96 percentage of pain reduction |