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Completed

NCT Number: NCT04654169

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

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.

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Key information

Conditions

Adhesive Capsulitis of the Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kardelen Gencer Atalay

Istanbul, 34899, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided IAI

Procedure

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

Ultrasound-guided SSNB

Procedure

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

Primary outcomes

  1. Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline (T0)

    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.

  2. Shoulder Pain and Disability Index (SPADI)

    Time frame: Three weeks after the intervention (T2)

    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.

  3. Shoulder Pain and Disability Index (SPADI)

    Time frame: Three months after the intervention (T3)

    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.

  4. Shoulder Pain and Disability Index (SPADI)

    Time frame: Twelve months after the intervention (T4)

    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.

Secondary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: Baseline (T0)

    Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.

  2. Numeric Rating Scale (NRS)

    Time frame: One hour after the intervention (T1)

    Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.

  3. Numeric Rating Scale (NRS)

    Time frame: Three weeks after the intervention (T2)

    Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.

  4. Numeric Rating Scale (NRS)

    Time frame: Three months after the intervention (T3)

    Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.

  5. Numeric Rating Scale (NRS)

    Time frame: Twelve months after the intervention (T4)

    Numeric Rating Scale (NRS) is used to grade pain intensity between 0 (no pain) to 10 (worst pain) by the patient.

  6. Short Form-36

    Time frame: Baseline (T0)

    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.

  7. Short Form-36

    Time frame: Three weeks after the intervention (T2)

    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.

  8. Short Form-36

    Time frame: Three months after the intervention (T3)

    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.

  9. Short Form-36

    Time frame: Twelve months after the intervention (T4)

    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.

  10. Shoulder range of motion (ROM) evaluated with a handheld goniometer

    Time frame: Baseline (T0)

    Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.

  11. Shoulder range of motion (ROM) evaluated with a handheld goniometer

    Time frame: One hour after the intervention (T1)

    Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.

  12. Shoulder range of motion (ROM) evaluated with a handheld goniometer

    Time frame: Three weeks after the intervention (T2)

    Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.

  13. Shoulder range of motion (ROM) evaluated with a handheld goniometer

    Time frame: Three months after the intervention (T3)

    Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.

  14. Shoulder range of motion (ROM) evaluated with a handheld goniometer

    Time frame: Twelve months after the intervention (T4)

    Shoulder range of motion (ROM) will be evaluated with a goniometer in all directions; flexion, extension, abduction, internal and external rotation.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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