Shoulder DislocationNCT02527603
Spaso Versus Self-assisted Maneuver for Anterior Shoulder Dislocation
A study testing Boss-Holzach-Matter method, Spaso method and Anti-Inflammatory Agents, Non-Steroidal in people with Shoulder Dislocation, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Boss-Holzach-Matter method, Spaso method and Anti-Inflammatory Agents, Non-Steroidal
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2015to Mar 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.
Who cannot join
- Fracture luxation of the same shoulder.
- Inability to cooperate due to mental or physical condition.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Corporación sanitaria Parc Taulí de Sabadell
Sabadell, Barcelona, 08208
About this study
Official title: Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations
To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.
Read the detailed description
Introduction: There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.
Hypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.
Objective: To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.
Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.
- Conditions
- Shoulder Dislocation
- Being tested
- Boss-Holzach-Matter method, Spaso method, Anti-Inflammatory Agents, Non-Steroidal
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boss-Holzach-Matter methodProcedure or surgery
Also called Self-assited Method
The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced
Spaso methodProcedure or surgery
The physician holds the dislocated arm of the patient in a supine position and proceeds with gentle, soft movements of adduction, flexion and external rotation of the limb in this order until reduction is accomplished.
Anti-Inflammatory Agents, Non-SteroidalDrug
Also called Pain Killer, "Enantyum®"
All patients will be administered a dose of NSAI intra-muscular or orally ("Dexketoprofen", "Enantyum®") it is part of the normal treatment of these patients to cope with pain.
| Study group | Role | What they receive |
|---|---|---|
| Spaso Method | Experimental | Randomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral Receives: Procedure: Spaso method; Drug: Anti-Inflammatory Agents, Non-Steroidal |
| Boss-Holzach-Matter Method | Experimental | Randomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral Receives: Procedure: Boss-Holzach-Matter method; Drug: Anti-Inflammatory Agents, Non-Steroidal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain that the patient experiences during the reduction procedure
Pain the patient feels during the reduction maneuver. The patient will be asked after reduction to fill out a form with a analog visual scale with scores ranging from 0 [no pain] to 10 [worst possible pain].
Measured: Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies 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
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesc A. Marcano-Fernández, Corporacion Parc Tauli
- Investigators
- David Marti, PhD, Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527603
- Sponsor's protocol ID
- CSPTCOT201501
- Status last verified
- Mar 2017
- First submitted
- 15 Aug 2015
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Sharing for other RCT, reviews, Meta analysis. Available from August 2017 Contact: famarcano@tauli.cat
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing the Spaso Maneuver Versus the Self-assisted Boss-Holzach-Matter for Anterior Shoulder Dislocations
- ClinicalTrials.gov ID
- NCT02527603
- Acronym / sponsor ID
- CSPTCOT201501
- Conditions
- Shoulder Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Aug 2015 (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.
To compare the results and efficacy of the self-assisted Boss-Holzach-Matter maneuver for anterior shoulder dislocation and the Spaso method performed by a physician.
Detailed description
Introduction: There are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. Most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. The Boss-Holzach-Matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method.
Hypothesis: The Boss-Holzach-Matter method is a less painful maneuver compared to the Spaso method assuming an equal success rate.
Objective: To determine whether the Boss-Holzach-Matter method is a less painful method for anterior shoulder dislocations compares to the Spaso method assuming equal success rate.
Methodology: Fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either Spaso reduction method performed by a physician or the self-assisted Boss-Holzach-Matter method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spaso Method | Experimental | Procedure: Spaso method, Drug: Anti-Inflammatory Agents, Non-SteroidalRandomized for Sp method + 1 initial dose of 50mg dexketoprofen IM or 25mg Oral |
| Boss-Holzach-Matter Method | Experimental | Procedure: Boss-Holzach-Matter method, Drug: Anti-Inflammatory Agents, Non-SteroidalRandomized for BHM method +1 initial dose of 50mg dexketoprofen IM or 25mg Oral |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area.
Key exclusion criteria (2 listed)
- Fracture luxation of the same shoulder.
- Inability to cooperate due to mental or physical condition.
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 |
|---|---|---|
| Boss-Holzach-Matter methodAlso: Self-assited MethodThe patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced | Procedure or surgery | Boss-Holzach-Matter Method |
| Spaso methodThe physician holds the dislocated arm of the patient in a supine position and proceeds with gentle, soft movements of adduction, flexion and external rotation of the limb in this order until reduction is accomplished. | Procedure or surgery | Spaso Method |
| Anti-Inflammatory Agents, Non-SteroidalAlso: Pain Killer, "Enantyum®"All patients will be administered a dose of NSAI intra-muscular or orally ("Dexketoprofen", "Enantyum®") it is part of the normal treatment of these patients to cope with pain. | Drug | Boss-Holzach-Matter Method, Spaso Method |
Primary outcome
Change From Baseline in Pain that the patient experiences during the reduction procedure
Time frame: Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.
Pain the patient feels during the reduction maneuver. The patient will be asked after reduction to fill out a form with a analog visual scale with scores ranging from 0 [no pain] to 10 [worst possible pain].
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 21 Mar 2017.
- Individual participant dataSharing planned: Undecided. Sharing for other RCT, reviews, Meta analysis. Available from August 2017 Contact: famarcano@tauli.cat
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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.
David Marti, PhD study director
Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boss-Holzach-Matter method, Spaso method and Anti-Inflammatory Agents, Non-Steroidal in people with Shoulder Dislocation, run by Corporacion Parc Tauli at 1 site in Spain.
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 2 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 21 Mar 2017. 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 Spain. 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 From Baseline in Pain that the patient experiences during the reduction procedure (time frame: Patients will be assessed throughout their visit to the Trauma Unit. No further following should be necessary.There will be no change in pain measurement, only the amount of pain felt during the manoeuvre.). 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 21 Mar 2017.