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Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis
This study has been completed.
Sponsor:
Universidade do Sul de Santa Catarina
Information provided by (Responsible Party):
Anna Paula Piovezan, Universidade do Sul de Santa Catarina
ClinicalTrials.gov Identifier:
NCT01306708
First received: March 1, 2011
Last updated: January 27, 2012
Last verified: September 2011
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Purpose
The adhesive capsulitis is a disease of the shoulder characterized by pain and limitation of movement amplitude. It is defined as for etiology, having discordant theories that related it to an inflammatory condition or to an algoneurodystrophy process. There is not yet a consensus about the best option of treatment. The non-steroidal anti-inflammatories have analgesic and anti-inflammatory activity, where the mechanism of action is the inhibition of prostaglandin synthesis. The antidepressants have been increasingly used in the control of chronic pain and the major action mechanism to have the analgesic effect seems to be based on inhibition of neurotransmitters reuptake noradrenaline and/or serotonin) in nerve cell endings. Literature studies associate the practice of the nerve suprascapular blockade with anaesthetics to good results of clinical improvement of the pain, however, so far, no clinical studies comparing the efficacy of the non-steroidal antiinflammatories or tricyclic antidepressants to nervous blockage were registered in the acute treatment of adhesive capsulitis.
| Condition | Intervention | Phase |
|---|---|---|
| Adhesive Capsulitis | Drug: amitriptyline | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Comparative Study Between Amitriptyline Regarding Nimesulide Associated to Nervous Blockade in the Acute Treatment of Idiopathic Adhesive Capsulitis |
Resource links provided by NLM:
Further study details as provided by Anna Paula Piovezan, Universidade do Sul de Santa Catarina:
Primary Outcome Measures:
- Pain and disability of the shoulder [ Time Frame: Days 0 and 14 after treatment begining ]Pain and disability of the shoulder, measured by the use of SPADI questionnaire.
| Enrollment: | 34 |
| Study Start Date: | February 2011 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: nimesulide
Nerve suprascapular blockade with local anaesthetic agent (novabupivacaine 0.25%, 10 ml, once per week) + oral non-steroidal anti-inflammatory (nimesulide 100 mg, twice per day, for 14 days);
|
Drug: amitriptyline
Nerve suprascapular blockade with local anaesthetic agent (novabupivacaine 0.25%, 10 ml, once per week) + oral tricyclic antidepressant (amitriptyline 25 mg, twice per day, for 14 days);
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with clinical diagnostic of adhesive capsulitis, phase II, presenting shoulder pain,
- Limitation of anterior elevation for up to 130 degrees,
- Intact rotator cuff to magnetic resonance,
- Minimum loss of 50% of external rotation when compared to the contralateral side.
- Patients' acceptance of take part in the study after signing the FCCT.
Exclusion Criteria:
- Incapacity to fill the evaluation instrument;
- Contraindication to the use of local anaesthetics, non-steroidal anti-inflammatories or tricyclic antidepressants.
- Pregnancy and breastfeeding.
- Not follow the orientations during treatment on the weeks included in the study, such as, using other anaesthetics or procedures for the relief of pain in this period.
- Lesion of the rotator cuff, infection and others arthropathies.
- Inability to fill a protocol.
- Previous surgery on the shoulder.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01306708
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306708
Locations
| Brazil | |
| Universidade do Sul de Santa Catarina | |
| Tubarão, Santa Catarina, Brazil, 88704-900 | |
Sponsors and Collaborators
Universidade do Sul de Santa Catarina
Investigators
| Principal Investigator: | Anna P Piovezan, Doctor | Universidade do Sul de Santa Catarina |
More Information
| Responsible Party: | Anna Paula Piovezan, Dra Anna Paula Piovezan, Universidade do Sul de Santa Catarina |
| ClinicalTrials.gov Identifier: | NCT01306708 History of Changes |
| Other Study ID Numbers: |
10.023.4.01.III 10.023.4.01 III ( Other Identifier: Universidade do Sul de Santa Catarina ) |
| Study First Received: | March 1, 2011 |
| Last Updated: | January 27, 2012 |
Keywords provided by Anna Paula Piovezan, Universidade do Sul de Santa Catarina:
|
Adhesive Capsulitis Shoulder SPADI |
Additional relevant MeSH terms:
|
Bursitis Periarthritis Rheumatic Diseases Joint Diseases Musculoskeletal Diseases Arthritis Connective Tissue Diseases Amitriptyline Nimesulide Amitriptyline, perphenazine drug combination Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Adrenergic Agents Neurotransmitter Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 23, 2017