Trial | NCT01306708  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    34
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.
Study Started
Feb 28
2011
Primary Completion
Jul 31
2011
Study Completion
Dec 31
2011
Last Update
Jan 31
2012
Estimate

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);

nimesulide Active Comparator

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);

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.
No Results Posted