NCT04897308

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 .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

11 months

First QC Date

May 16, 2021

Last Update Submit

April 5, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Suprascapular nerve block

ACTIVE COMPARATOR

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

Hydrodilatation of shoulder capsule

ACTIVE COMPARATOR

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

Hydrodilatation of shoulder interval

ACTIVE COMPARATOR

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

Interventions

Under ultrasound guidance , local shoulder joint injection will be done

Hydrodilatation of shoulder capsuleHydrodilatation of shoulder intervalSuprascapular nerve block

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty

Sohag, Egypt

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 21, 2021

Study Start

May 1, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations