Clinical trial NCT04654169: Suprascapular Nerve Block in Addition to Intra-articular Corticosteroid Injection in Adhesive Capsulitis
Official title: Effectiveness of Suprascapular Nerve Block in Addition to Intra-articular Corticosteroid Injection in Adhesive Capsulitis: A Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis of the Shoulder
Keywords: Adhesive Capsulitis of the Shoulder
Intra-Articular Injections
Nerve Blockade
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: A double-blind, randomized controlled trial, to have two groups with a single arm
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline (T0)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Three weeks after the intervention (T2)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Three months after the intervention (T3)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Twelve months after the intervention (T4)
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Baseline (T0)
measure: Numeric Rating Scale (NRS)
timeFrame: One hour after the intervention (T1)
measure: Numeric Rating Scale (NRS)
timeFrame: Three weeks after the intervention (T2)
measure: Numeric Rating Scale (NRS)
timeFrame: Three months after the intervention (T3)
measure: Numeric Rating Scale (NRS)
timeFrame: Twelve months after the intervention (T4)
measure: Short Form-36
timeFrame: Baseline (T0)
measure: Short Form-36
timeFrame: Three weeks after the intervention (T2)
measure: Short Form-36
timeFrame: Three months after the intervention (T3)
measure: Short Form-36
timeFrame: Twelve months after the intervention (T4)
measure: Shoulder range of motion (ROM) evaluated with a handheld goniometer
timeFrame: Baseline (T0)
measure: Shoulder range of motion (ROM) evaluated with a handheld goniometer
timeFrame: One hour after the intervention (T1)
measure: Shoulder range of motion (ROM) evaluated with a handheld goniometer
timeFrame: Three weeks after the intervention (T2)
measure: Shoulder range of motion (ROM) evaluated with a handheld goniometer
timeFrame: Three months after the intervention (T3)
measure: Shoulder range of motion (ROM) evaluated with a handheld goniometer
timeFrame: Twelve months after the intervention (T4)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kardelen Gencer Atalay
Study officials:
affiliation: Marmara University
name: Ilker Yagci, Prof
role: STUDY_DIRECTOR
References: