Hydrodilatation Versus Arthroscopic Capsular Release for Frozen Shoulder
NCT ID: NCT03463538
Last Updated: 2018-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2013-06-30
2017-06-30
Brief Summary
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Detailed Description
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The participating patients will be randomised in a 1:1 allocation to arthroscopic capsular release (ACR) or hydrodilatation (HD). The randomisation will be administered by a central independent randomisation service, provided by a medical secretary using a computer generated randomisation sequence, who is completely independent of the trial.
All patients will be asked to fill out a number of questionnaires prior to surgery: the Oxford Shoulder Score (OSS) and the EQ-5D. The range of movement within the shoulder joint will be documented in a standard fashion.
Each patient will then undergo the assigned procedure according to the randomisation. The ACR would be performed by one of the Consultant Shoulder surgeons in their standard manner. The Hydro-dilatation would be performed by one of the Consultant Musculoskeletal radiologists in their standard manner. This would ensure that the options at each step of the operation or procedure, such as patient positioning, approach to the shoulder joint, and the closure of the wound etc are left entirely to the discretion of the Consultant performing the procedure. This will ensure that the results of the trial can be generalised to as wide a group of patients and surgeons as possible.
After the operation, patients will be reviewed using the range of movement, OSS, a patient satisfaction score and EQ-5D at 6 weeks, 3 months, and 6 months post-operatively. A record will be kept of any complications associated with the treatment. This data will be collected with by the research associate, who is independent of either intervention.
The main analysis will investigate differences in the primary outcome measure the OSS, between the two treatment groups (ACR and HD) on an intention-to-treat basis, at 6 months post-operation. Secondary outcome measures will be analysed in a similar manner. Statistical analysis will be undertaken by a statistician blinded to the interventions. Advice will be sought from an independent statistician provided by the trust to confirm the statistical methodology.
The economic evaluation will investigate the comparative cost-effectiveness of ACR versus HD. Health outcomes within 6 months follow-up will be assessed using the EuroQoL data collected within the trial, which will be valued using the standard UK TTO tariff to produce Quality-Adjusted Life-Year (QALY) estimates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arthroscopic capsular release
Surgical release performed under general anesthetic
arthroscopic capsular release
surgical release of shoulder joint capsule
Hydro-dilatation
injection of water under local anesthetic in to shoulder joint
Hydro-dilatation
dilatation of shoulder joint capsule using water pressure under local anesthetic
Interventions
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arthroscopic capsular release
surgical release of shoulder joint capsule
Hydro-dilatation
dilatation of shoulder joint capsule using water pressure under local anesthetic
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Royal Devon and Exeter NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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chris smith
Role: PRINCIPAL_INVESTIGATOR
Royal Devon and Exeter
Locations
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Royal Devon and Exeter hospital
Exeter, Devon, United Kingdom
Countries
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Other Identifiers
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1312873
Identifier Type: -
Identifier Source: org_study_id
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