Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

NCT01306708 | Completed Phase 2

• 2 other identifiers: 10.023.4.01.III10.023.4.01 III
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis; Shoulder; SPADI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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);

Drug: amitriptyline

Interventions

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);

nimesulide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Sul de Santa Catarina: lead

Study Sites (1)

Universidade do Sul de Santa Catarina

Tubarão, Santa Catarina, 88704-900, Brazil

Location

MeSH Terms

Conditions

Bursitis

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Anna P Piovezan, Doctor

  Universidade do Sul de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dra Anna Paula Piovezan

Study Record Dates

• First Submitted: March 1, 2011
• First Posted: March 2, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2011-09

Locations

BR (1)