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

Effectiveness of Suprascapular Nerve Block in Addition to Intra-articular Corticosteroid Injection in Adhesive Capsulitis: A Double-blind, Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis of the Shoulder
• Intervention / Treatment: Procedure: Ultrasound-guided IAI; Procedure: Ultrasound-guided SSNB

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34899
    • Kardelen Gencer Atalay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 were:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Ultrasound-guided IAI; Ultrasound-guided IAI was applied with a posterior glenohumeral joint in-plane injection technique.; Procedure: Ultrasound-guided SSNB; Ultrasound-guided SSNB was carried out with a supraspinatus fossa level in-plane injection technique
Active Comparator: 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.	Procedure: Ultrasound-guided IAI; Ultrasound-guided IAI was applied with a posterior glenohumeral joint in-plane injection technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of 13 items divided into two subscales varying between 0 to 100, with a higher value indicating worse condition.	Baseline (T0)
Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of 13 items divided into two subscales varying between 0 to 100, with a higher value indicating worse condition.	Three weeks after the intervention (T2)
Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of 13 items divided into two subscales varying between 0 to 100, with a higher value indicating worse condition.	Three months after the intervention (T3)
Shoulder Pain and Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire consisting of 13 items divided into two subscales varying between 0 to 100, with a higher value indicating worse condition.	Twelve months after the intervention (T4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale (NRS)	Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.	Baseline (T0)
Numeric Rating Scale (NRS)	Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.	One hour after the intervention (T1)
Numeric Rating Scale (NRS)	Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.	Three weeks after the intervention (T2)
Numeric Rating Scale (NRS)	Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.	Three months after the intervention (T3)
Numeric Rating Scale (NRS)	Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.	Twelve months after the intervention (T4)
Short Form-36	Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.	Baseline (T0)
Short Form-36	Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.	Three weeks after the intervention (T2)
Short Form-36	Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.	Three months after the intervention (T3)
Short Form-36	Short Form-36 (SF-36) is a widely-used and well-documented health-related quality of life index. The SF-36 consists of 36 questions; It survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually. A higher score on a 0-100 scale indicates a better quality of life.	Twelve months after the intervention (T4)
Shoulder range of motion (ROM) evaluated with a handheld goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.	Baseline (T0)
Shoulder range of motion (ROM) evaluated with a handheld goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.	One hour after the intervention (T1)
Shoulder range of motion (ROM) evaluated with a handheld goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.	Three weeks after the intervention (T2)
Shoulder range of motion (ROM) evaluated with a handheld goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.	Three months after the intervention (T3)
Shoulder range of motion (ROM) evaluated with a handheld goniometer	Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.	Twelve months after the intervention (T4)

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: Ilker Yagci, Prof, Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 27, 2020
• First Submitted That Met QC Criteria: November 27, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 5, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Nerve Blockade; Adhesive Capsulitis of the Shoulder; Intra-Articular Injections
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 09.2018.836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No