NCT06725823

Brief Summary

he study will include 50 patients with frozen shoulder with no healthy volunteer , Patients in this study will be randomized into two groups suprascapular nerve block and Shoulder anterior capsular block

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
2mo left

Started Jan 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2025Jul 2026

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

December 5, 2024

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain (Visual analogue scale)

    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

    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

    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

    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.

Study Arms (2)

suprascapular nerve block group

ACTIVE COMPARATOR

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

Procedure: suprascapular nerve block group

shoulder anterior capsular block group

ACTIVE COMPARATOR

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 .

Procedure: shoulder anterior capsular block group

Interventions

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.

suprascapular nerve block group

A volume of (10ml) of 2% lidocaine (7ml), 3% Mepivacaine (2ml), 1 ml methyl-prednisolone acetate (40mg) will be injected to both groups.

shoulder anterior capsular block group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university

Sohag, Egypt

RECRUITING

Related Publications (3)

  • 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/

  • 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.

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Hanan Sayed Mohamed AboZaid, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
patients will not be aware about which type of intervention they will recieve also the care provider and outcome assessor will be not aware about type of intervention patients will recieve
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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 and Suprascapular nerve block group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Physical Medicine, Rheumatology &Rehabilitation

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

January 10, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations