Shoulder Anterior Capsular Block and Intraarticular Steroid Injection Versus Intraarticular Steroid Injection for Enhancing Pain Relief in Adhesive Capsulitis

November 17, 2025 updated by: Dina Abdelhameed Elsadek Salem, Zagazig University

Comparative Study Between Shoulder Anterior Capsular Block Plus Steroid Injection Versus Steroid Injection Alone for Pain Management in Adhesive Capsulitis: A Randomized Trial

Improving pain in the patients with adhesive capsulitis by comparing the effect of combined shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Comparing between combined shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection for enhancing pain relief in adhesive capsulitis as regards:

  • To measure analgesic parameters including: assessment of pain score by using Visual Analogue Score during 8 weeks follow up in comparison to baseline and total amount of rescue analgesic (ibuprofen) consumption.
  • To assess the Shoulder pain and Disability Index
  • To record complications of the block (local anesthetic toxicity, infection, bleeding, nerve injury)
  • Over all patient's satisfaction: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Recruiting
        • Faculity of Medicine, Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients acceptance
  • Age: 41-65 years old
  • Sex: both sex (males or females).
  • Physical status: American Society of Anesthesiologist (ASA) І, II.
  • Patients attend orthopedic or pain clinic with complaint of shoulder pain and stiffness. These patients received conservative management of pain with no relief of symptoms for at least 2 weeks.

Exclusion Criteria:

  • Shoulder pain due to secondary causes, e.g. acute trauma, fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder.

    • Patient with any contraindications of regional blocks (as coagulopathy or local infection at injection site)
    • Patients with known history of allergy to the study drugs (bupivacaine and methylprednisolone).
    • Advanced hepatic, renal, cardiovascular, neurologic and respiratory diseases, uncontrolled diabetes mellitus and thyroid.
    • History of neuropathy in the involved limb or previous revision surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group Shoulder anterior capsular block (SHAC)
patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint
Procedure: Group Group Shoulder anterior capsular block (SHAC)
patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint followed by home exercise program.
Active Comparator: Group intraarticular steroid injection (IASI)
patients will receive intraarticular steroid injection of the affected shoulder joint
Procedure: Group intraarticular steroid injection (IASI)
patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: BEFORE STARTING PROCEDURE (0 hour)(baseline)
measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
BEFORE STARTING PROCEDURE (0 hour)(baseline)
pain intensity
Time Frame: 15 minutes after the procedure
measured by Visual Analogue Scale(VAS) as 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
15 minutes after the procedure
pain intensity
Time Frame: first 6 hours postoperative
measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
first 6 hours postoperative
pain intensity
Time Frame: one week after procedure
measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
one week after procedure
pain intensity
Time Frame: 3 weeks after procedure
measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
3 weeks after procedure
pain intensity
Time Frame: 6 weeks after procedure
measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
6 weeks after procedure
pain intensity
Time Frame: 8 weeks after procedure
measured by Visual Analogue Scale (VAS) 10 cm line labelled (0-10), in which 0 presents no pain and 10 represents the worst pain in each participant
8 weeks after procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of Shoulder Pain and Disability Index (SPADI)
Time Frame: baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure
SPADI contains 13 items that assess two domains - a five item subscale that measures pain and an eight item subscale that measures disability. Each subscale scored 10 ranging from 0 (best) to 10 (worst). It is a self administered, valid questionnaire,
baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure
Total amount of rescue analgesia
Time Frame: first 24 hours
Total amount of rescue analgesia (ibuprofen)
first 24 hours
patient's satisfaction
Time Frame: 1 week after procedure
degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
1 week after procedure
Complications of SHAC block
Time Frame: 24 hours
Complications of SHAC block (local anesthetic toxicity, infection, bleeding)
24 hours
PASSIVE AND ACTIVE RANGE OF MOTION
Time Frame: at baseline, first week and third week follow up post intervention.
Passive and active shoulder flexion, abduction, and external rotation will be measured using goniometer
at baseline, first week and third week follow up post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zagazig University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dina Salem, MD, Faculty of medicine, Zagazig university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1593

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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