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Trial record 9 of 52 for:    "Frozen Shoulder"

Hydrodilatation Versus Arthroscopic Capsular Release for Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT03463538
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

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

Condition or disease Intervention/treatment Phase
Frozen Shoulder Procedure: arthroscopic capsular release Procedure: Hydro-dilatation Not Applicable

Detailed Description:

All potential participants for this study will be identified by an Orthopaedic Shoulder Consultant in the shoulder clinics run at the Royal Devon and Exeter NHS trust. The patients will be screened for eligibility by a research associate (SG). The eligibility criteria will be that the patient is medically fit for an operation, and has severe primary frozen shoulder in the acute painful stage, that is deemed suitable for intervention by the consultant surgeon. The patients will be informed verbally and in writing about the trial by the research associate and informed consent will be taken.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised control trial between interventions
Masking: Single (Outcomes Assessor)
Masking Description: independent clinical reviewer of patients ROM and collection of outcome scores
Primary Purpose: Treatment
Official Title: A Randomised Control Trial of Arthroscopic Capsular Release Versus Hydrodilatation for Primary Adhesive Capsulitis of the Shoulder
Actual Study Start Date : June 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Active Comparator: Arthroscopic capsular release
Surgical release performed under general anesthetic
Procedure: arthroscopic capsular release
surgical release of shoulder joint capsule

Active Comparator: Hydro-dilatation
injection of water under local anesthetic in to shoulder joint
Procedure: Hydro-dilatation
dilatation of shoulder joint capsule using water pressure under local anesthetic




Primary Outcome Measures :
  1. Oxford shoulder score [ Time Frame: at 6months ]
    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


Secondary Outcome Measures :
  1. Visual analogue score [ Time Frame: at 6 months ]
    pain score from 0 to 10 marked by patient on a continuous line. 0 being the worst score

  2. clinical assessment of range of movement (external rotation, internal rotation, forward flexion and abduction) [ Time Frame: at 6 months ]
    clinical assessment of range of movement using goniometer at the shoulder joint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463538


Locations
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United Kingdom
Royal Devon and Exeter hospital
Exeter, Devon, United Kingdom
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
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Principal Investigator: chris smith Royal Devon and Exeter

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Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03463538     History of Changes
Other Study ID Numbers: 1312873
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs