Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder

NCT04709874 | Unknown

• 1 other identifier: 11012021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Shoulder

Outcome Measures

Primary Outcomes (1)

• Pain score

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

  6 months

Study Arms (2)

Paravertebral block

EXPERIMENTAL

Patients will receive paravertebral block guided by a nerve stimulator.

Other: Paravertebral block

Suprascapular block

ACTIVE COMPARATOR

Patients will receive suprascapular block

Other: Suprascapular block

Interventions

Paravertebral block OTHER

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

Paravertebral block

Suprascapular block OTHER

Paravertebral block using nerve stimulator guidance will be done

Suprascapular block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• presenting with frozen shoulder and were unresponsive to conservative therapy

You may not qualify if:

• Complete rotator cuff tear
• Osteoarthritis
• Calcified tendinitis
• History of shoulder joint injury
• Cervical radiculopathy
• Bleeding disorder
• Active infection
• Allergy to Bupivacaine
• Diabetes Mellitus

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zoher Naja, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoher Naja, MD

CONTACT

+9611636000; zouhnaja@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthiologist

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: January 2, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 18, 2022

Record last verified: 2022-01

Locations

LE (1)