Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

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Abstract

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.

Dates

Last Verified:	08/31/2011
First Submitted:	02/28/2011
Estimated Enrollment Submitted:	02/28/2011
First Posted:	03/01/2011
Last Update Submitted:	01/26/2012
Last Update Posted:	01/30/2012
Actual Study Start Date:	01/31/2011
Estimated Primary Completion Date:	06/30/2011
Estimated Study Completion Date:	11/30/2011

Condition or disease

Adhesive Capsulitis

Intervention/treatment

Drug: nimesulide

Phase

Phase 2

Arm Groups

Arm	Intervention/treatment
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);	Drug: nimesulide 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);

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
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.

Outcome

Primary Outcome Measures

1. Pain and disability of the shoulder [Days 0 and 14 after treatment begining]

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

Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

Keywords

serotonin

noradrenaline

prostaglandin

prostaglandin f 2 alpha

chronic pain

inflammation

bursitis

anti inflammatory

antidepressant

analgesic

antidepressants