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

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 Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Drug: amitriptyline

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Tubarão, Santa Catarina, Brazil, 88704-900
      • Universidade do Sul de Santa Catarina

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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);

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and disability of the shoulder	Pain and disability of the shoulder, measured by the use of SPADI questionnaire.	Days 0 and 14 after treatment begining

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 1, 2011
• First Submitted That Met QC Criteria: March 1, 2011
• First Posted (Estimate): March 2, 2011

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 27, 2012
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Shoulder; Adhesive Capsulitis; SPADI
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Amitriptyline
• Other Study ID Numbers: 10.023.4.01.III; 10.023.4.01 III (Other Identifier: Universidade do Sul de Santa Catarina)