MedDataX Logo

Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis

NCT ID: NCT01306708

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adhesive Capsulitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Adhesive Capsulitis Shoulder SPADI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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);

Group Type ACTIVE_COMPARATOR

amitriptyline

Intervention Type 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);

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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);

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade do Sul de Santa Catarina

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna Paula Piovezan

Dra Anna Paula Piovezan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna P Piovezan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Universidade do Sul de Santa Catarina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade do Sul de Santa Catarina

Tubarão, Santa Catarina, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10.023.4.01 III

Identifier Type: OTHER

Identifier Source: secondary_id

10.023.4.01.III

Identifier Type: -

Identifier Source: org_study_id