Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

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.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidade do Sul de Santa Catarina

Tubarão, Santa Catarina, 88704-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amitriptyline

Drug

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);

Primary outcomes

Pain and disability of the shoulder

Time frame: Days 0 and 14 after treatment begining

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

Sponsors and collaborators

Lead sponsor

Universidade do Sul de Santa Catarina

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Mar 2, 2011
Registry last updated: Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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