Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Paula Piovezan, Universidade do Sul de Santa Catarina
ClinicalTrials.gov Identifier:
NCT01306708
First received: March 1, 2011
Last updated: January 27, 2012
Last verified: September 2011
History of Changes
  Purpose
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 Intervention Phase
Adhesive Capsulitis
 Drug: amitriptyline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade do Sul de Santa Catarina:

Primary Outcome Measures:
  • Pain and disability of the shoulder [ Time Frame: Days 0 and 14 after treatment begining ] [ Designated as safety issue: No ]
    Pain and disability of the shoulder, measured by the use of SPADI questionnaire.
Enrollment: 34
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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);

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306708

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 
Study First Received: March 1, 2011
Last Updated: January 27, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade do Sul de Santa Catarina:
Adhesive Capsulitis
Shoulder
SPADI

Additional relevant MeSH terms:
Periarthritis
Rheumatic Diseases
Bursitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Amitriptyline
Nimesulide
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

ClinicalTrials.gov processed this record on September 27, 2016