Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03245476 - Education-based Physical Therapy Approach for Adhesive Capsulitis N/A
Recruiting NCT03462420 - Physiotherapy Program for Managing Adhesive Capsulitis in Patients With Diabetes N/A
Recruiting NCT06181461 - Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis N/A
Completed NCT03678038 - Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder N/A
Completed NCT01458691 - Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis N/A
Recruiting NCT01449227 - Natural Course of Adhesive Capsulitis of Hip N/A
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT05398588 - Spencer's Muscle Energy Technique and Cyriax Deep Friction Massage on Adhesive Capsulitis N/A
Completed NCT05402540 - Effectiveness of SCS Technique Verses ART in Adhesive Capsulitis N/A
Recruiting NCT03676829 - Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis Phase 1/Phase 2
Active, not recruiting NCT06404814 - Effectiveness of Functional Electrical Stimulation Versus Spencer Technique in Patients With Adhesive Capsulitis N/A
Completed NCT06019780 - Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis N/A
Completed NCT06062654 - Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis N/A
Completed NCT04822324 - Spencer's Muscle Energy Technique Along With Strain Counter Strain in Adhesive Capsulitis. N/A
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Recruiting NCT06041282 - Conservative Treatment of Early Adhesive Capsulitis N/A
Withdrawn NCT03770546 - Amnion-Based Injections in the Shoulder N/A
Completed NCT06064396 - Effects of Gong's Mobilization With and Without Stecco Fascial Therapy in Patients With Adhesive Capsulitis N/A
Completed NCT04852939 - Bowen's Technique in Patients With Adhesive Capsulitis N/A
Completed NCT05655611 - Muscle Energy Technique With Or Without First Rib Mobilization In Adhesive Capsulitis N/A