Best Treatment Modality of Frozen Shoulder

Shoulder Adhesive Capsulitis ; Comparison Between Three Theraputic Approaches

This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .

Study Overview

• Status: Completed
• Conditions: Shoulder Adhesive Capsulitis
• Intervention / Treatment: Procedure: Local injection of shoulder joint

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• gross limitation of passive shoulder movement
• pain interfering with daily activities
• painful restiction of active and passive movement of shoulder

Exclusion Criteria:

• presence of degenerative pathology
• fracture
• contraindication to steroid injection
• deformity affecting upper limb
• history of previous shoulder injection in the past 4 weeks

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Suprascapular nerve block; This group will include will under go suprascapularnerve block as following :10 ml of .5% bupivacaine and 2 ml of methylpradnisolon 40mg/ml	Procedure: Local injection of shoulder joint; Under ultrasound guidance , local shoulder joint injection will be done
Active Comparator: Hydrodilatation of shoulder capsule; This group will undergo intraarticular hydrodilatation by injection of :first lidocaine10ml%followed by 1ml of methylprednisolon 40mg/ml and finally 20ml of .9 % sodium chloride slowly in the gleno humeral joint	Procedure: Local injection of shoulder joint; Under ultrasound guidance , local shoulder joint injection will be done
Active Comparator: Hydrodilatation of shoulder interval; This group will undergo interval hydrodilatation by injection of :first mepivacaine 10ml folowed by 20ml of sterile water slowly in the shoulder interval	Procedure: Local injection of shoulder joint; Under ultrasound guidance , local shoulder joint injection will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in range of motion of shoulder joint	Improvement will be measured by measuring active and passive range of motion	12 weeks efter intervention
Improvement in pain	Improvement will be measured by VAS ( visual auditory assessment )	12 weeks after intervention

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: Soh-Med-21-05-04

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