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Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

Information source: Universidade do Sul de Santa Catarina
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adhesive Capsulitis

Intervention: amitriptyline (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Universidade do Sul de Santa Catarina

Official(s) and/or principal investigator(s):
Anna P Piovezan, Doctor, Principal Investigator, Affiliation: Universidade do Sul de Santa Catarina

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.

Clinical Details

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

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

Primary outcome: Pain and disability of the shoulder

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Universidade do Sul de Santa Catarina, Tubarão, Santa Catarina 88704-900, Brazil
Additional Information

Starting date: February 2011
Last updated: January 27, 2012

Page last updated: August 23, 2015

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