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

NCT04654169 | Completed

• 1 other identifier: 09.2018.836
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis of the Shoulder

Keywords

Adhesive Capsulitis of the Shoulder; Intra-Articular Injections; Nerve Blockade

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Numeric Rating Scale (NRS)

  Baseline (T0)

• Numeric Rating Scale (NRS)

  One hour after the intervention (T1)

• Numeric Rating Scale (NRS)

  Three weeks after the intervention (T2)

• Numeric Rating Scale (NRS)

  Three months after the intervention (T3)

• Numeric Rating Scale (NRS)

  Twelve months after the intervention (T4)

Study Arms (2)

The IAI and SSNB group

EXPERIMENTAL

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; Procedure: Ultrasound-guided SSNB

The only-IAI group

ACTIVE COMPARATOR

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

Interventions

Ultrasound-guided IAI PROCEDURE

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

The IAI and SSNB group; The only-IAI group

Ultrasound-guided SSNB PROCEDURE

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

The IAI and SSNB group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Kardelen Gencer Atalay

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Ilker Yagci, Prof

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A double-blind, randomized controlled trial, to have two groups with a single arm

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: February 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)