Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder

NCT ID: NCT04709874

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-02

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paravertebral block

Patients will receive paravertebral block guided by a nerve stimulator.

Group Type EXPERIMENTAL

Paravertebral block

Intervention Type OTHER

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

Suprascapular block

Patients will receive suprascapular block

Group Type ACTIVE_COMPARATOR

Suprascapular block

Intervention Type OTHER

Paravertebral block using nerve stimulator guidance will be done

Interventions

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Paravertebral block

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

Intervention Type OTHER

Suprascapular block

Paravertebral block using nerve stimulator guidance will be done

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Makassed General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zoher Naja

Anesthiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zoher Naja, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

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Makassed General Hospital

Beirut, , Lebanon

Site Status RECRUITING

Countries

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Lebanon

Central Contacts

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Zoher Naja, MD

Role: CONTACT

+9611636000 ext. 6405

Facility Contacts

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Zoher Naja, MD

Role: primary

+9611636000 ext. 6405

Other Identifiers

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11012021

Identifier Type: -

Identifier Source: org_study_id

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