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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01306708
Enrollment
34
Registered
2011-03-02
Start date
2011-02-28
Completion date
2011-12-31
Last updated
2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis, Shoulder, SPADI

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.

Interventions

DRUGamitriptyline

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);

Sponsors

Universidade do Sul de Santa Catarina
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain and disability of the shoulderDays 0 and 14 after treatment beginingPain and disability of the shoulder, measured by the use of SPADI questionnaire.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026