NCT03463538

Brief Summary

To compare the Oxford shoulder score at 6 months post intervention for primary frozen shoulder randomised to either an arthroscopic capsular release or hydro-dilatation

Trial Health

87
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
Completed

Started Jun 2013

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

3.5 years

First QC Date

February 28, 2018

Last Update Submit

March 13, 2018

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • Oxford shoulder score

    Patient reported outcome with a maximum score of 48 and minimum of 0. 48 being the best outcome. Comprises 12 questions relating to pain and function specific to the shoulder

    at 6months

Secondary Outcomes (2)

  • Visual analogue score

    at 6 months

  • clinical assessment of range of movement (external rotation, internal rotation, forward flexion and abduction)

    at 6 months

Study Arms (2)

Arthroscopic capsular release

ACTIVE COMPARATOR

Surgical release performed under general anesthetic

Procedure: arthroscopic capsular release

Hydro-dilatation

ACTIVE COMPARATOR

injection of water under local anesthetic in to shoulder joint

Procedure: Hydro-dilatation

Interventions

arthroscopic capsular releasePROCEDURE

surgical release of shoulder joint capsule

Arthroscopic capsular release
Hydro-dilatationPROCEDURE

dilatation of shoulder joint capsule using water pressure under local anesthetic

Hydro-dilatation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medically fit for an operation; normal x-ray; Codmans criteria frozen shoulder

You may not qualify if:

  • Secondary causes of frozen shoulder; rotator cuff tears found at arthroscopy or hydro-dilatation; unable to adhere to trial protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Devon and Exeter hospital

Exeter, Devon, United Kingdom

Location

MeSH Terms

Conditions

Bursitis

Interventions

Joint Capsule Release

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ArthroscopyEndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Study Officials

  • chris smith

    Royal Devon and Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
independent clinical reviewer of patients ROM and collection of outcome scores
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomised control trial between interventions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 13, 2018

Study Start

June 1, 2013

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

March 14, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)