Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

• ClinicalTrials.gov Identifier: NCT01306708
• Recruitment Status: Completed
• First Posted: March 2, 2011
• Last Update Posted: January 31, 2012
• Sponsor: Universidade do Sul de Santa Catarina
• Information provided by (Responsible Party): Anna Paula Piovezan, Universidade do Sul de Santa Catarina

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Adhesive Capsulitis	Drug: amitriptyline	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study Between Amitriptyline Regarding Nimesulide Associated to Nervous Blockade in the Acute Treatment of Idiopathic Adhesive Capsulitis
• Study Start Date: February 2011
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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: 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);

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Brazil

Universidade do Sul de Santa Catarina

Tubarão, Santa Catarina, Brazil, 88704-900

Sponsors and Collaborators

Universidade do Sul de Santa Catarina

Investigators

• Principal Investigator: Anna P Piovezan, Doctor; Universidade do Sul de Santa Catarina

More Information

• Responsible Party: Anna Paula Piovezan, Dra Anna Paula Piovezan, Universidade do Sul de Santa Catarina
• ClinicalTrials.gov Identifier: NCT01306708 History of Changes
• Other Study ID Numbers: 10.023.4.01.III; 10.023.4.01 III ( Other Identifier: Universidade do Sul de Santa Catarina )
• First Posted: March 2, 2011
• Last Update Posted: January 31, 2012
• Last Verified: September 2011

Keywords provided by Anna Paula Piovezan, Universidade do Sul de Santa Catarina:

Adhesive Capsulitis; Shoulder; SPADI

Additional relevant MeSH terms:

Bursitis; Joint Diseases; Musculoskeletal Diseases; Nimesulide; Amitriptyline; Amitriptyline, perphenazine drug combination; Antidepressive Agents, Tricyclic; Antidepressive Agents; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Neurotransmitter Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors