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
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