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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01306708
Other study ID # 10.023.4.01.III
Secondary ID 10.023.4.01 III
Status Completed
Phase Phase 2
First received March 1, 2011
Last updated January 27, 2012
Start date February 2011
Est. completion date December 2011

Study information

Verified date September 2011
Source Universidade do Sul de Santa Catarina
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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);

Locations

Country Name City State
Brazil Universidade do Sul de Santa Catarina Tubarão Santa Catarina

Sponsors (1)

Lead Sponsor Collaborator
Universidade do Sul de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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