- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06725823
Therapeutic Effect of Shoulder Anterior Capsular Block Versus Suprascapular Nerve Block in Patients With Frozen Shoulder
Therapeutic Effect of Shoulder Anterior Capsular Block (SHAC) Versus Suprascapular Nerve Block in Patients With Frozen Shoulder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will include 50 patients with frozen shoulder with no healthy volunteer , Patients in this study will be randomized into two groups according to the treatment performed .
Shoulder anterior capsular block group
Description:
Ultrasound guided injection For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible. With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle. By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin. Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, we also reach the intra-articular space .
Suprascapular nerve block group
Description:
Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine the needle will be inserted .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed
- A volume of (10ml) of 2% lidocaine (2ml), 3% Mepivacaine (2ml) , 1 ml methyl-prednisolone acetate (40 mg) and dextrose 5% (5ml) will be injected to both groups.
- All patients in both groups will receive immediate stretching exercises and post injection 3 times weekly followed by home exercises
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hanan Sayed Mohamed AboZaid, Professor
- Phone Number: 01017049050
- Email: hanan72eg@yahoo.com
Study Locations
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-
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Sohag, Egypt
- Recruiting
- Sohag University
-
Contact:
- Hanan S Mohamed AboZaid, professor
- Phone Number: 01017049050
- Email: hanan72eg@yahoo.com
-
Principal Investigator:
- Ayat Abdulwahab Othman Mahmoud, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age above 18 years.
- Both sexes, males and females.
- History of complaint >6 weeks
- Restricted shoulder movement unilaterally in at least 2 planes including abduction, external rotation, and internal rotation and restricted passive movement.
Exclusion Criteria:
Patient refusal.
- -Allergy to local anaesthetics.
- -Infection at the site of injection .
- -Coagulopathy
- -Prolonged opioid medication
- -Pregnancy
- -Acute trauma, fracture of the shoulder
- People who had received an intra-articular shoulder injection within the last 6 months.
- Patients with tendon tear
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: suprascapular nerve block group
Patients will be placed in lateral position by using A high - frequency linear ultrasound probe will be placed approximately 2 cm medial to the medial border of the acromion and about 2 cm cranial to the superior margin of the scapular spine the needle will be inserted .The tip of the needle will be placed at the floor of the supraspinatus fossa where the nerve has passed
|
A volume of (10 ml) of 2% lidocaine (7ml), 3% Mepivacaine (2ml), 1 ml methyl-prednisolone acetate (40 mg) will be injected to both groups.
|
|
Active Comparator: shoulder anterior capsular block group
Ultrasound guided injection For the SHAC block, with the patient in a beach-chair position and with the arm in extension, the subscapularis muscle is stretched posteriorly and becomes easily visible.
With external rotation and abduction, the coracobrachialis and the biceps brachii muscles are displaced, allowing the visualization of the interfascial space between the deep lamina of the deltoid muscle fascia and the superficial lamina of the subscapularis fascia.Once the injection into the fascial space is achieved, the investigators can proceed towards the glenohumeral pericapsular space by crossing the subscapularis muscle with the needle.
By injecting the pericapsular space, the investigators reach the terminal articular branches indistinctly from their origin.
Furthermore, through the Weitbrecht foramen, a natural capsular foramen between the upper and middle glenohumeral ligaments, we also reach the intra-articular space .
|
A volume of (10ml) of 2% lidocaine (7ml), 3% Mepivacaine (2ml), 1 ml methyl-prednisolone acetate (40mg) will be injected to both groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain (Visual analogue scale)
Time Frame: at baseline and post-procedure at 1, 3 and 6 months.
|
s a validated, subjective measure for acute and chronic pain.
Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
|
at baseline and post-procedure at 1, 3 and 6 months.
|
|
total pain scores
Time Frame: at baseline and post-procedure at 1, 3 and 6 months.
|
is a combination of simple pain score, radiation, and sleep disturbance score
|
at baseline and post-procedure at 1, 3 and 6 months.
|
|
shoulder pain disability index
Time Frame: at baseline and post-procedure at 1, 3 and 6 months.
|
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
The pain dimension consists of five questions regarding the severity of an individual's pain.
Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
|
at baseline and post-procedure at 1, 3 and 6 months.
|
|
active range of movement of the shoulder joint
Time Frame: at baseline and post-procedure at 1, 3 and 6 months.
|
The active and passive range of abduction, adduction, flexion , extension , internal rotation and external rotation will be measured using goniometry
|
at baseline and post-procedure at 1, 3 and 6 months.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Brindisino F, Girardi G, Crestani M, Assenza R, Andriesse A, Giovannico G, Pellicciari L, Salomon M, Venturin D. Rehabilitation in subjects with frozen shoulder: a survey of current (2023) clinical practice of Italian physiotherapists. BMC Musculoskelet Disord. 2024 Jul 23;25(1):573. doi: 10.1186/s12891-024-07682-w.
- Millar NL, Meakins A, Struyf F, Willmore E, Campbell AL, Kirwan PD, Akbar M, Moore L, Ronquillo JC, Murrell GAC, Rodeo SA. Frozen shoulder. Nat Rev Dis Primers. 2022 Sep 8;8(1):59. doi: 10.1038/s41572-022-00386-2.
- Basta M, Sanganeria T, Varacallo MA. Anatomy, Shoulder and Upper Limb, Suprascapular Nerve. 2022 Oct 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557880/
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-11__2MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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