Frozen ShoulderNCT03463538
Hydrodilatation Versus Arthroscopic Capsular Release for Frozen Shoulder
A study testing arthroscopic capsular release and Hydro-dilatation in people with Frozen Shoulder, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- arthroscopic capsular release and Hydro-dilatation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medically fit for an operation; normal x-ray; Codmans criteria frozen shoulder
Who cannot join
- Secondary causes of frozen shoulder; rotator cuff tears found at arthroscopy or hydro-dilatation; unable to adhere to trial protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Control Trial of Arthroscopic Capsular Release Versus Hydrodilatation for Primary Adhesive Capsulitis of the Shoulder
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
Read the 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.
- Conditions
- Frozen Shoulder
- Being tested
- arthroscopic capsular release, Hydro-dilatation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic capsular releaseProcedure or surgery
surgical release of shoulder joint capsule
Hydro-dilatationProcedure or surgery
dilatation of shoulder joint capsule using water pressure under local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic capsular release | Active comparator | Surgical release performed under general anesthetic Receives: Procedure: arthroscopic capsular release |
| Hydro-dilatation | Active comparator | injection of water under local anesthetic in to shoulder joint Receives: Procedure: Hydro-dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6months
Secondary outcomes (2)
Visual analogue score
pain score from 0 to 10 marked by patient on a continuous line. 0 being the worst score
Measured: at 6 months
clinical assessment of range of movement (external rotation, internal rotation, forward flexion and abduction)
clinical assessment of range of movement using goniometer at the shoulder joint
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startJun 2013
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised control trial between interventions
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chris smith, Principal investigator, Royal Devon and Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463538
- Sponsor's protocol ID
- 1312873
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of Arthroscopic Capsular Release Versus Hydrodilatation for Primary Adhesive Capsulitis of the Shoulder
- ClinicalTrials.gov ID
- NCT03463538
- Acronym / sponsor ID
- 1312873
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised control trial between interventions
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic capsular release | Active comparator | Procedure: arthroscopic capsular releaseSurgical release performed under general anesthetic |
| Hydro-dilatation | Active comparator | Procedure: Hydro-dilatationinjection of water under local anesthetic in to shoulder joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medically fit for an operation; normal x-ray; Codmans criteria frozen shoulder
Key exclusion criteria (1 listed)
- Secondary causes of frozen shoulder; rotator cuff tears found at arthroscopy or hydro-dilatation; unable to adhere to trial protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic capsular releasesurgical release of shoulder joint capsule | Procedure or surgery | Arthroscopic capsular release |
| Hydro-dilatationdilatation of shoulder joint capsule using water pressure under local anesthetic | Procedure or surgery | Hydro-dilatation |
Primary outcome
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
2 secondary outcomes
Visual analogue score
Time frame: at 6 months
clinical assessment of range of movement (external rotation, internal rotation, forward flexion and abduction)
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chris smith principal investigator
Royal Devon and Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic capsular release and Hydro-dilatation in people with Frozen Shoulder, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford shoulder score (time frame: at 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.