Amitriptyline Regarding Nimesulide in Acute Idiopathic Adhesive Capsulitis
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ClinicalTrials.gov Identifier: NCT01306708 |
Recruitment Status :
Completed
First Posted : March 2, 2011
Last Update Posted : January 31, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adhesive Capsulitis | Drug: amitriptyline | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
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);
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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); |
- Pain and disability of the shoulder [ Time Frame: Days 0 and 14 after treatment begining ]Pain and disability of the shoulder, measured by the use of SPADI questionnaire.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306708
Brazil | |
Universidade do Sul de Santa Catarina | |
Tubarão, Santa Catarina, Brazil, 88704-900 |
Principal Investigator: | Anna P Piovezan, Doctor | Universidade do Sul de Santa Catarina |
Responsible Party: | Anna Paula Piovezan, Dra Anna Paula Piovezan, Universidade do Sul de Santa Catarina |
ClinicalTrials.gov Identifier: | NCT01306708 |
Other Study ID Numbers: |
10.023.4.01.III 10.023.4.01 III ( Other Identifier: Universidade do Sul de Santa Catarina ) |
First Posted: | March 2, 2011 Key Record Dates |
Last Update Posted: | January 31, 2012 |
Last Verified: | September 2011 |
Adhesive Capsulitis Shoulder SPADI |
Bursitis Joint Diseases Musculoskeletal Diseases Amitriptyline 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 |