Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 135 for:    AMITRIPTYLINE

Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 1, 2011
First Posted Date  ICMJE March 2, 2011
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01306708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis
Official Title  ICMJE Comparative Study Between Amitriptyline Regarding Nimesulide Associated to Nervous Blockade in the Acute Treatment of Idiopathic Adhesive Capsulitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adhesive Capsulitis
Intervention  ICMJE 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);
Study Arms  ICMJE 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);
Intervention: Drug: amitriptyline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2011)
34
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01306708
Other Study ID Numbers  ICMJE 10.023.4.01.III
10.023.4.01 III ( Other Identifier: Universidade do Sul de Santa Catarina )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Paula Piovezan, Universidade do Sul de Santa Catarina
Study Sponsor  ICMJE Universidade do Sul de Santa Catarina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna P Piovezan, Doctor Universidade do Sul de Santa Catarina
PRS Account Universidade do Sul de Santa Catarina
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP