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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04709874
Other study ID # 11012021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2022
Est. completion date January 2023

Study information

Verified date January 2022
Source Makassed General Hospital
Contact Zoher Naja, MD
Phone +9611636000
Email zouhnaja@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder. Objectives: The primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. The primary outcome is pain measured through the Visual Analogue Scale (VAS) over a follow up period of 6 months. Methods: This is a prospective randomized clinical trial that will be conducted between February 2021 and January 2022. Patients will be randomly allocated into two groups. Group I will receive paravertebral block guided by a nerve stimulator. Group II patients will receive suprascapular nerve block. Patients will be followed up at week 1, month 1, month 3 and month 6.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and older - presenting with frozen shoulder and were unresponsive to conservative therapy Exclusion Criteria: - Complete rotator cuff tear - Osteoarthritis - Calcified tendinitis - History of shoulder joint injury - Cervical radiculopathy - Bleeding disorder - Active infection - Allergy to Bupivacaine - Diabetes Mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Paravertebral block
Paravertebral block using nerve stimulator guidance will be done at C7-T1
Suprascapular block
Paravertebral block using nerve stimulator guidance will be done

Locations

Country Name City State
Lebanon Makassed General Hospital Beirut

Sponsors (1)

Lead Sponsor Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score Pain will measured through the Visual Analogue Scale (VAS). 0 indicates no pain and 10 indicates maximum pain 6 months
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