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Best Treatment Modality of Frozen Shoulder

Primary Purpose

Shoulder Adhesive Capsulitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Local injection of shoulder joint

About this trial

This is an interventional treatment trial for Shoulder Adhesive Capsulitis

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sohag faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Suprascapular nerve block

Hydrodilatation of shoulder capsule

Hydrodilatation of shoulder interval

Arm Description

This group will include will under go suprascapularnerve block as following :10 ml of .5% bupivacaine and 2 ml of methylpradnisolon 40mg/ml

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

This group will undergo interval hydrodilatation by injection of :first mepivacaine 10ml folowed by 20ml of sterile water slowly in the shoulder interval

Outcomes

Primary Outcome Measures

Improvement in range of motion of shoulder joint

Improvement will be measured by measuring active and passive range of motion

Improvement in pain

Improvement will be measured by VAS ( visual auditory assessment )

Secondary Outcome Measures

Full Information

NCT ID

NCT04897308

First Posted

May 16, 2021

Last Updated

April 5, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04897308

Brief Title

Best Treatment Modality of Frozen Shoulder

Official Title

Shoulder Adhesive Capsulitis ; Comparison Between Three Theraputic Approaches

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

April 1, 2022 (Actual)

Study Completion Date

April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Adhesive Capsulitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suprascapular nerve block

Arm Type

Active Comparator

Arm Description

This group will include will under go suprascapularnerve block as following :10 ml of .5% bupivacaine and 2 ml of methylpradnisolon 40mg/ml

Arm Title

Hydrodilatation of shoulder capsule

Arm Type

Active Comparator

Arm Description

Arm Title

Hydrodilatation of shoulder interval

Arm Type

Active Comparator

Arm Description

This group will undergo interval hydrodilatation by injection of :first mepivacaine 10ml folowed by 20ml of sterile water slowly in the shoulder interval

Intervention Type

Procedure

Intervention Name(s)

Local injection of shoulder joint

Intervention Description

Under ultrasound guidance , local shoulder joint injection will be done

Primary Outcome Measure Information:

Title

Improvement in range of motion of shoulder joint

Description

Improvement will be measured by measuring active and passive range of motion

Time Frame

12 weeks efter intervention

Title

Improvement in pain

Description

Improvement will be measured by VAS ( visual auditory assessment )

Time Frame

12 weeks after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Sohag faculty

City

Sohag

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Best Treatment Modality of Frozen Shoulder

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