NCT07235982

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

September 29, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

shoulder anterior capsular blockintraarticular steroid injectionadhesive capsulitis

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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

    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

    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

    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

    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

    8 weeks after procedure

Secondary Outcomes (5)

  • Assessment of Shoulder Pain and Disability Index (SPADI)

    baseline (0 ) and subsequently at one week, 3 weeks , 6 weeks and 8 weeks after procedure

  • Total amount of rescue analgesia

    first 24 hours

  • patient's satisfaction

    1 week after procedure

  • Complications of SHAC block

    24 hours

  • PASSIVE AND ACTIVE RANGE OF MOTION

    at baseline, first week and third week follow up post intervention.

Study Arms (2)

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

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

Procedure: Group intraarticular steroid injection (IASI)

Interventions

patients will receive ultrasound guided (SHAC) block combined with intraarticular steroid injection of the affected shoulder joint followed by home exercise program.

Group Shoulder anterior capsular block (SHAC)

patients will receive intraarticular steroid injection of the affected shoulder joint followed by home exercise program

Group intraarticular steroid injection (IASI)

Eligibility Criteria

Age41 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculity of Medicine, Zagazig University

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

AgnosiaBursitis

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Dina Salem, MD

    FACULTY OF MEDICINE, ZAGAZIG UNIVERSITY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessors are blind to the study groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: pain relief in adhesive capsulitis by comparing shoulder anterior capsular block and intraarticular steroid injection versus intraarticular steroid injection
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 29, 2025

First Posted

November 19, 2025

Study Start

October 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations