Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title:

Comparative Study Between Amitriptyline Regarding Nimesulide Associated to Nervous Blockade in the Acute Treatment of Idiopathic Adhesive Capsulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306708
• Other study ID #: 10.023.4.01.III
• Secondary ID: 10.023.4.01 III
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2011
• Last updated: January 27, 2012
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2011
• Source: Universidade do Sul de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Periarthritis

Intervention

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);

Locations

Country	Name	City	State
Brazil	Universidade do Sul de Santa Catarina	Tubarão	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Sul de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and disability of the shoulder	Pain and disability of the shoulder, measured by the use of SPADI questionnaire.	Days 0 and 14 after treatment begining	No