Atraumatic Shoulder InstabilityNCT01751490
Effectiveness of Surgery for Atraumatic Shoulder Instability
A study testing physiotherapy and shoulder stabilisation surgery in people with Atraumatic Shoulder Instability, run by Royal National Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
We will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atraumatic Shoulder Instability
- What is being tested?
- physiotherapy and shoulder stabilisation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2013to Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- feelings of insecurity (apprehension) at their shoulder joint
- provocation of apprehension with drawer and apprehension tests
- evidence labral/capsular injury in the shoulder joint
Who cannot join
- a history of a high collision shoulder injury precipitating apprehension symptoms
- evidence of bony injury around glenoid rim/and or humeral head
- a pristine joint i.e. no evidence of any structural injury to the joint, capsule or labrum.
- a rotator cuff tear
- neural damage affecting the upper limb
- previous shoulder surgery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal National Orthopaedic Hospital NHS Trust
Stanmore, Middlesex, HA7 4LP
About this study
Official title: Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?
We will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with bony/capsulolabral damage. The results of this study will have direct and immediate impact on clinical decision making by establishing definitively if patients presenting with joint damage associated with atraumatic shoulder instability should be referred for surgery before commencing physiotherapy rehabilitation. The results of this study may also result in significant cost savings to the National Health Service if surgical intervention for atraumatic shoulder instability does not result in greater improvement than physiotherapy alone.
Read the detailed description
A two-arm, patient, physiotherapist and assessor-blinded, randomised controlled clinical trial will be conducted. 140 patients will be randomly allocated into one of 2 groups: a stabilisation surgery group and a control group. Primary outcomes (pain and disability) and secondary outcomes (participant-reported improvement and incidence of shoulder dislocations) will be evaluated at baseline and 6, 12 and 24 months after randomisation. Additional secondary outcomes of shoulder rotation range of motion and strength will be evaluated 6 months after randomisation.
- Conditions
- Atraumatic Shoulder Instability
- Being tested
- physiotherapy, shoulder stabilisation surgery
- Keywords
- shoulder, instability, atraumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
physiotherapy
shoulder stabilisation surgeryProcedure or surgery
Also called arthroscopic stabilisation surgery
arthroscopic stabilisation surgery
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy alone | Active comparator | patients undergoing physiotherapy only Receives: Other: physiotherapy; Procedure: shoulder stabilisation surgery |
| surgery and physiotherpay | Active comparator | patients receiving surgical treatment followed by physiotherapy Receives: Other: physiotherapy; Procedure: shoulder stabilisation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index.
Looking at time points of baseline, 6 months, 12 months and 24 months
Measured: over 24 months
Secondary outcomes (1)
Global perceived effect assessing participant-perceived improvement
Measured: over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atraumatic Shoulder InstabilityStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal National Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Principal investigator, Iva Hauptmannova, Royal National Orthopaedic Hospital NHS Trust
- Investigators
- Anju Jaggi, BSc, Principal investigator, Royal National Orthopaedic Hospital NHS TrustSusan Alexander, MD, Principal investigator, Royal National Orthopaedic Hospital NHS Trust & UCLKaren Ginn, BSc, PhD, Principal investigator, University of SydneyAndrew Symonds, BSc, MSc, Principal investigator, Royal National Orthopaedic Hospital NHS TrustSuzie Cro, BSc, Principal investigator, Royal National Orthopaedic Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751490
- Sponsor's protocol ID
- 12.024
- Status last verified
- Apr 2023
- First submitted
- 5 Dec 2012
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaggi A, Herbert RD, Alexander S, Majed A, Butt D, Higgs D, Rudge W, Ginn KA. Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial. Br J Sports Med. 2023 Dec;57(23):1484-1489. doi: 10.1136/bjsports-2022-106596. Epub 2023 Jun 12.
PubMed 37308285Jaggi A, Alexander S, Herbert R, Funk L, Ginn KA. Does surgery followed by physiotherapy improve short and long term outcome for patients with atraumatic shoulder instability compared with physiotherapy alone? - protocol for a randomized controlled clinical trial. BMC Musculoskelet Disord. 2014 Dec 17;15:439. doi: 10.1186/1471-2474-15-439.
PubMed 25515666
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Surgery Followed by Physiotherapy Improve Short and Long Term Outcomes for Patients With Atraumatic Shoulder Instability Compared With Physiotherapy Alone?
- ClinicalTrials.gov ID
- NCT01751490
- Acronym / sponsor ID
- 12.024
- Conditions
- Atraumatic Shoulder Instability
- Keywords
- shoulder, instability, atraumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Royal National Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- Feb 2013
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 18 Dec 2012 (estimated)
- 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.
We will conduct a randomised clinical trial with the primary aim of determining whether surgical intervention followed by physiotherapy rehabilitation improves pain and disability outcomes more than physiotherapy rehabilitation alone in patients suffering from atraumatic shoulder instability associated with bony/capsulolabral damage. The results of this study will have direct and immediate impact on clinical decision making by establishing definitively if patients presenting with joint damage associated with atraumatic shoulder instability should be referred for surgery before commencing physiotherapy rehabilitation. The results of this study may also result in significant cost savings to the National Health Service if surgical intervention for atraumatic shoulder instability does not result in greater improvement than physiotherapy alone.
Detailed description
A two-arm, patient, physiotherapist and assessor-blinded, randomised controlled clinical trial will be conducted. 140 patients will be randomly allocated into one of 2 groups: a stabilisation surgery group and a control group. Primary outcomes (pain and disability) and secondary outcomes (participant-reported improvement and incidence of shoulder dislocations) will be evaluated at baseline and 6, 12 and 24 months after randomisation. Additional secondary outcomes of shoulder rotation range of motion and strength will be evaluated 6 months after randomisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physiotherapy alone | Active comparator | Other: physiotherapy, Procedure: shoulder stabilisation surgerypatients undergoing physiotherapy only |
| surgery and physiotherpay | Active comparator | Other: physiotherapy, Procedure: shoulder stabilisation surgerypatients receiving surgical treatment followed by physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- feelings of insecurity (apprehension) at their shoulder joint
- provocation of apprehension with drawer and apprehension tests
- evidence labral/capsular injury in the shoulder joint
Key exclusion criteria (6 listed)
- a history of a high collision shoulder injury precipitating apprehension symptoms
- evidence of bony injury around glenoid rim/and or humeral head
- a pristine joint i.e. no evidence of any structural injury to the joint, capsule or labrum.
- a rotator cuff tear
- neural damage affecting the upper limb
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 |
|---|---|---|
| physiotherapyphysiotherapy | Other | physiotherapy alone, surgery and physiotherpay |
| shoulder stabilisation surgeryAlso: arthroscopic stabilisation surgeryarthroscopic stabilisation surgery | Procedure or surgery | physiotherapy alone, surgery and physiotherpay |
Primary outcome
Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index.
Time frame: over 24 months
Looking at time points of baseline, 6 months, 12 months and 24 months
1 secondary outcome
Global perceived effect assessing participant-perceived improvement
Time frame: over 24 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 25 Apr 2023.
- Derived from this study: PubMed 37308285Jaggi A, Herbert RD, Alexander S, Majed A, Butt D, Higgs D, Rudge W, Ginn KA. Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial. Br J Sports Med. 2023 Dec;57(23):1484-1489. doi: 10.1136/bjsports-2022-106596. Epub 2023 Jun 12.
- Derived from this study: PubMed 25515666Jaggi A, Alexander S, Herbert R, Funk L, Ginn KA. Does surgery followed by physiotherapy improve short and long term outcome for patients with atraumatic shoulder instability compared with physiotherapy alone? - protocol for a randomized controlled clinical trial. BMC Musculoskelet Disord. 2014 Dec 17;15:439. doi: 10.1186/1471-2474-15-439.
- Royal National Orthopaedics Hospital (RNOH) main websiteLink provided by the sponsor.
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.
Anju Jaggi, BSc principal investigator
Royal National Orthopaedic Hospital NHS Trust
Susan Alexander, MD principal investigator
Royal National Orthopaedic Hospital NHS Trust & UCL
Karen Ginn, BSc, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy and shoulder stabilisation surgery in people with Atraumatic Shoulder Instability, run by Royal National Orthopaedic Hospital NHS 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 3 inclusion and 6 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 25 Apr 2023. 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?
Change in pain and functional impairment, measured using the Western Ontario Shoulder Instability Index. (time frame: over 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751490, which also lists 2 linked publications.
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 25 Apr 2023.