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Suprascapular Nerve Block in Addition to Intra-articular Corticosteroid Injection in Adhesive Capsulitis

NCT ID: NCT04654169

Last Updated: 2020-12-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-05-01

Brief Summary

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Adhesive capsulitis is a disease that negatively affects a person's quality of life by causing severe pain and limitation in the movements of the shoulder joint in all directions. Conservative approaches including nonsteroidal anti-inflammatory drugs or oral corticosteroid usage and physiotherapy program are the first choice for the treatment. However, painful exercises usually prevent patients from fully participating in the physiotherapy program. For this reason, interventional procedures such as intra-articular corticosteroid injection (IAI) and suprascapular nerve block (SSNB) are preferred to be applied before the physiotherapy program.

The aim of this study is to reveal both short and long-term effects of SSNB and IAI combination on pain, shoulder range of motion (ROM), disability, and quality of life in patients with adhesive capsulitis. It is hypothesized that the addition of SSNB to IAI results in greater improvements in pain, passive and active shoulder ROMs, disability, and quality of life.

Detailed Description

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Adhesive capsulitis (AK), also known as frozen shoulder, is a disease that negatively affects a person's quality of life by causing severe pain and limitation in the movements of the shoulder joint in all directions. Although the underlying etiology is not clear, it may develop as a result of primary (idiopathic) or secondary causes such as diabetes mellitus, malignancy, thyroid dysfunction, hypoadrenalism, Parkinson's disease, stroke, cardiac and pulmonary diseases, or local shoulder problems such as trauma, tendinitis, rupture. Prolonged immobilization after injuries is another important risk factor for adhesive capsulitis. It is more common in women between the ages of 40-60. Conservative approaches including nonsteroidal anti-inflammatory drugs or oral corticosteroid usage and physiotherapy program are the first choice for the treatment. The physiotherapy program consisting range of motion (ROM), stretching and strengthening exercises are often painful and prevent the patient's full participation. For this reason, interventional procedures such as intra-articular corticosteroid injection (IAI) and suprascapular nerve block (SSNB) are preferred to be applied before the physiotherapy program.

The aim of this study is to reveal both short and long-term effects of SSNB and IAI combination on pain, shoulder ROM, disability, and quality of life in patients with adhesive capsulitis. It is hypothesized that the addition of SSNB to IAI results in greater improvements in pain, passive and active shoulder ROMs, disability, and quality of life. The primary outcome measure of the study is determined to be the Shoulder Pain and Disability Index (SPADI), while the secondary outcome measures to be the Numeric Rating Scale (NRS), active and passive ROMs, and the Short Form 36 (SF-36).

Conditions

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Adhesive Capsulitis of the Shoulder

Keywords

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Adhesive Capsulitis of the Shoulder Intra-Articular Injections Nerve Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

A double-blind, randomized controlled trial, to have two groups with a single arm
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Allocation information of patients was only given to the physiatrists who would apply the intervention. Another physiatrist who completed the pre and post-treatment assessments and the patients were blinded to the allocation.

Study Groups

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The IAI and SSNB group

Ultrasound-guided IAI and SSNB are planned to apply by at least three-year experienced physiatrists. Patients are planned to initiate a six-week rehabilitation program supervised by the same physiotherapist one day after the intervention.

Group Type EXPERIMENTAL

Ultrasound-guided IAI

Intervention Type PROCEDURE

Ultrasound-guided IAI was applied with a posterior glenohumeral joint in-plane injection technique.

Ultrasound-guided SSNB

Intervention Type PROCEDURE

Ultrasound-guided SSNB was carried out with a supraspinatus fossa level in-plane injection technique

The only-IAI group

Ultrasound-guided IAI is planned to apply by at least three-year experienced physiatrists. Patients are planned to initiate a six-week rehabilitation program supervised by the same physiotherapist one day after the intervention.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided IAI

Intervention Type PROCEDURE

Ultrasound-guided IAI was applied with a posterior glenohumeral joint in-plane injection technique.

Interventions

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Ultrasound-guided IAI

Ultrasound-guided IAI was applied with a posterior glenohumeral joint in-plane injection technique.

Intervention Type PROCEDURE

Ultrasound-guided SSNB

Ultrasound-guided SSNB was carried out with a supraspinatus fossa level in-plane injection technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of adhesive capsulitis
* Bening of symptoms at least three months prior
* Having shoulder pain with passive ROM limitation greater than 30° compared to normal values in at least two directions

Exclusion Criteria

* Adhesive capsulitis stages 3 and 4
* Previous trauma, IAI, or surgery history
* Evidence of complete rotator cuff tear, calcific tendinitis, biceps tendinitis, glenohumeral or acromioclavicular arthritis on magnetic resonance imaging
* Uncontrolled diabetes mellitus
* Known coagulation disorder
* Contraindication to corticosteroid or local anesthetic injection.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Kardelen Gencer Atalay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilker Yagci, Prof

Role: STUDY_DIRECTOR

Marmara University

Locations

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Kardelen Gencer Atalay

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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09.2018.836

Identifier Type: -

Identifier Source: org_study_id