AnalgesiaNCT07235982
Shoulder Anterior Capsular Block and Intraarticular Steroid Injection Versus Intraarticular Steroid Injection for Enhancing Pain Relief in Adhesive Capsulitis
A study testing Group Group Shoulder anterior capsular block (SHAC) and Group intraarticular steroid injection (IASI) in people with Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 41 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Group Group Shoulder anterior capsular block (SHAC) and Group intraarticular steroid injection (IASI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculity of Medicine, Zagazig University
Zagazig
About this study
Official title: 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.
Read the 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).
- Conditions
- Analgesia
- Being tested
- Group Group Shoulder anterior capsular block (SHAC), Group intraarticular steroid injection (IASI)
- Keywords
- shoulder anterior capsular block, intraarticular steroid injection, adhesive capsulitis
- Medical subject headings
- Agnosia, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Group Shoulder anterior capsular block (SHAC)Procedure or surgery
patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint followed by home exercise program.
Group intraarticular steroid injection (IASI)Procedure or surgery
patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program
| Study group | Role | What they receive |
|---|---|---|
| Group Shoulder anterior capsular block (SHAC) | Active comparator | patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint Receives: Procedure: Group Group Shoulder anterior capsular block (SHAC) |
| Group intraarticular steroid injection (IASI) | Active comparator | patients will receive intraarticular steroid injection of the affected shoulder joint Receives: Procedure: Group intraarticular steroid injection (IASI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
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
Measured: BEFORE STARTING PROCEDURE (0 hour)(baseline)
pain intensity
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
Measured: 15 minutes after the procedure
pain intensity
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
Measured: first 6 hours postoperative
pain intensity
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
Measured: one week after procedure
pain intensity
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
Measured: 3 weeks after procedure
pain intensity
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
Measured: 6 weeks after procedure
pain intensity
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
Measured: 8 weeks after procedure
Secondary outcomes (5)
Assessment of Shoulder Pain and Disability Index (SPADI)
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,
Measured: baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure
Total amount of rescue analgesia
Total amount of rescue analgesia (ibuprofen)
Measured: first 24 hours
patient's satisfaction
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)
Measured: 1 week after procedure
Complications of SHAC block
Complications of SHAC block (local anesthetic toxicity, infection, bleeding)
Measured: 24 hours
PASSIVE AND ACTIVE RANGE OF MOTION
Passive and active shoulder flexion, abduction, and external rotation will be measured using goniometer
Measured: at baseline, first week and third week follow up post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Oct 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pain relief in adhesive capsulitis by comparing shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
- Investigators
- Dina Salem, MD, Principal investigator, FACULTY OF MEDICINE, ZAGAZIG UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235982
- Sponsor's protocol ID
- 1593
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Shoulder Anterior Capsular Block Plus Steroid Injection Versus Steroid Injection Alone for Pain Management in Adhesive Capsulitis: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07235982
- Acronym / sponsor ID
- 1593
- Conditions
- Analgesia
- Keywords
- shoulder anterior capsular block, intraarticular steroid injection, adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pain relief in adhesive capsulitis by comparing shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection
| Arm | Type | Receives |
|---|---|---|
| Group Shoulder anterior capsular block (SHAC) | Active comparator | 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 |
| Group intraarticular steroid injection (IASI) | Active comparator | Procedure: Group intraarticular steroid injection (IASI)patients will receive intraarticular steroid injection of the affected shoulder joint |
Who may qualify
- Ages
- 41 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Shoulder pain due to secondary causes, e.g. acute trauma, fractures, bony deformity, glenohumeral joint pathology, acromioclavicular joint pathology and rotator cuff disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group Shoulder anterior capsular block (SHAC) |
| Group intraarticular steroid injection (IASI)patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program | Procedure or surgery | Group intraarticular steroid injection (IASI) |
Primary outcome
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
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
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
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
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
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
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
5 secondary outcomes
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
Total amount of rescue analgesia
Time frame: first 24 hours
patient's satisfaction
Time frame: 1 week after procedure
Complications of SHAC block
Time frame: 24 hours
PASSIVE AND ACTIVE RANGE OF MOTION
Time frame: at baseline, first week and third week follow up post intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dina Salem, MD principal investigator
FACULTY OF MEDICINE, ZAGAZIG UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Group Shoulder anterior capsular block (SHAC) and Group intraarticular steroid injection (IASI) in people with Analgesia, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Salem, MD (01099333513 ext. 002, dinamaghraby@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: BEFORE STARTING PROCEDURE (0 hour)(baseline)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.