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Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

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ClinicalTrials.gov Identifier: NCT01306708
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Anna Paula Piovezan, Universidade do Sul de Santa Catarina

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Adhesive Capsulitis Drug: amitriptyline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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);


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306708


Locations
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Brazil
Universidade do Sul de Santa Catarina
Tubarão, Santa Catarina, Brazil, 88704-900
Sponsors and Collaborators
Universidade do Sul de Santa Catarina
Investigators
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Principal Investigator: Anna P Piovezan, Doctor Universidade do Sul de Santa Catarina
More Information
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Responsible Party: Anna Paula Piovezan, Dra Anna Paula Piovezan, Universidade do Sul de Santa Catarina
ClinicalTrials.gov Identifier: NCT01306708    
Other Study ID Numbers: 10.023.4.01.III
10.023.4.01 III ( Other Identifier: Universidade do Sul de Santa Catarina )
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: September 2011
Keywords provided by Anna Paula Piovezan, Universidade do Sul de Santa Catarina:
Adhesive Capsulitis
Shoulder
SPADI
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Amitriptyline
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