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Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder

Primary Purpose

Pain, Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Paravertebral block
Suprascapular block
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makassed General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paravertebral block

Suprascapular block

Arm Description

Patients will receive paravertebral block guided by a nerve stimulator.

Patients will receive suprascapular block

Outcomes

Primary Outcome Measures

Pain score
Pain will measured through the Visual Analogue Scale (VAS). 0 indicates no pain and 10 indicates maximum pain

Secondary Outcome Measures

Full Information

First Posted
January 12, 2021
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04709874
Brief Title
Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder
Official Title
Paravertebral Block Versus Suprascapular Block for Treatment of Frozen Shoulder: a Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral block
Arm Type
Experimental
Arm Description
Patients will receive paravertebral block guided by a nerve stimulator.
Arm Title
Suprascapular block
Arm Type
Active Comparator
Arm Description
Patients will receive suprascapular block
Intervention Type
Other
Intervention Name(s)
Paravertebral block
Intervention Description
Paravertebral block using nerve stimulator guidance will be done at C7-T1
Intervention Type
Other
Intervention Name(s)
Suprascapular block
Intervention Description
Paravertebral block using nerve stimulator guidance will be done
Primary Outcome Measure Information:
Title
Pain score
Description
Pain will measured through the Visual Analogue Scale (VAS). 0 indicates no pain and 10 indicates maximum pain
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6405
Email
zouhnaja@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6405
Email
zouhnaja@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder

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