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Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
amitriptyline
Sponsored by
Universidade do Sul de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, Shoulder, SPADI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade do Sul de Santa Catarina

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

nimesulide

Arm Description

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);

Outcomes

Primary Outcome Measures

Pain and disability of the shoulder
Pain and disability of the shoulder, measured by the use of SPADI questionnaire.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2011
Last Updated
January 27, 2012
Sponsor
Universidade do Sul de Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT01306708
Brief Title
Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis
Official Title
Comparative Study Between Amitriptyline Regarding Nimesulide Associated to Nervous Blockade in the Acute Treatment of Idiopathic Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Sul de Santa Catarina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
Adhesive Capsulitis, Shoulder, SPADI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nimesulide
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
amitriptyline
Intervention Description
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);
Primary Outcome Measure Information:
Title
Pain and disability of the shoulder
Description
Pain and disability of the shoulder, measured by the use of SPADI questionnaire.
Time Frame
Days 0 and 14 after treatment begining

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna P Piovezan, Doctor
Organizational Affiliation
Universidade do Sul de Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade do Sul de Santa Catarina
City
Tubarão
State/Province
Santa Catarina
ZIP/Postal Code
88704-900
Country
Brazil

12. IPD Sharing Statement

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Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

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