Shoulder PainNCT03041727
Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercises
A study testing Fascial Manipulation and Standard exercises protocol in people with Shoulder Pain and Manual Therapy, run by Azienda Ospedaliera Bolognini di Seriate Bergamo at 1 site in Italy.
Trial summary
The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Manual Therapy
- What is being tested?
- Fascial Manipulation and Standard exercises protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 1 Aug 2021
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- shoulder pain and acute and relapse in six months
- positive results in two orthopedic testes
Who cannot join
- Degenerative diseases and neurological diseases
- Rheumatological Diseases and cancer
- fracture of the humerus, scapula and collarbone
- documented injury of rotator cuff.
- cortisones therapy in action
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercise
The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol.
Read the detailed description
The shoulder degenerative diseases are recurring in hospital employees. The early approach, as we see in literature, has high probability to reduce the pain and the disfunction in the long term.
In particular stretching and strengthening exercises are the standard protocol applied.
The Fascial Manipulation is a manual therapy that works on the connective tissue, by increasing mobility and reducing pain.
We have added the Fascial Manipulation to prove if it make a faster recovery and a pain reduction in the short and the middle term.
- Conditions
- Shoulder Pain, Manual Therapy
- Being tested
- Fascial Manipulation, Standard exercises protocol
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial ManipulationOther
Fascial Manipulation is a manual therapy that focused on deep muscular fascial.
Standard exercises protocolOther
Stretching and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | Active comparator | The subjects will be treated with a standard protocol of stretching and strengthening exercises , we require them to do the exercises by themselves during five weeks, one a day.
To make sure that they will do the protocol, we'll give them a diary to sign the daily section. Receives: Other: Standard exercises protocol |
| Intervention group | Experimental | The subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach. Receives: Other: Fascial Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
VNS scale in the Apley 'Scratch Test
Measured: Before and after the first treatment. A week after the enrollment.
Secondary outcomes (9)
shoulder' function
Constant Morley Scale
Measured: Before and after the first treatment. A week after the enrollment.
shoulder' function
Constant Morley Scale
Measured: Before and after the fifth treatment, after five weeks. This will be the last treatment
shoulder' function
Constant Morley Scale
Measured: A month later the last treatment, as follow up
Range of Movement of the shoulder
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Measured: Before and after the first treatment. A week after the enrollment.
Range of Movement of the shoulder
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Measured: Before and after the fifth treatment, after five weeks.This will be the last treatment
Range of Movement of the shoulder
Bubble Inclinometer used in the flexion, abduction and external rotation movement
Measured: A month later the last treatment, as follow up
The shoulder's muscular strength
dynamometer survey in flexion and abduction movement
Measured: Before and after the first treatment. A week after the enrollment.
The shoulder's muscular strength
dynamometer survey in flexion and abduction movement
Measured: Before and after the fifth treatment, after five weeks. This will be the last treatment
The shoulder's muscular strength
dynamometer survey in flexion and abduction movement
Measured: A month later the last treatment, as follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Participants are assigned to one of two or more groups in parallel for the duration of the study are evaluated in parallel against a control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, silvia Bellotti, Azienda Ospedaliera Bolognini di Seriate Bergamo
- Investigators
- Massimo Busato, first level, Study director, Azienda Ospedaliera Bolognini di Seriate Bergamo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041727
- Sponsor's protocol ID
- AOBolognini 1
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2017
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapist Approach to Shoulder's Diseases, Differences Between Fascial Manipulation and Standard Exercise
- ClinicalTrials.gov ID
- NCT03041727
- Acronym / sponsor ID
- AOBolognini 1
- Conditions
- Shoulder Pain, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate BergamoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 3 Feb 2017 (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.
The study purpose is to compare the effects of Fascial Manipulation added to standard exercises protocol versus the simple exercises protocol.
Detailed description
The shoulder degenerative diseases are recurring in hospital employees. The early approach, as we see in literature, has high probability to reduce the pain and the disfunction in the long term.
In particular stretching and strengthening exercises are the standard protocol applied.
The Fascial Manipulation is a manual therapy that works on the connective tissue, by increasing mobility and reducing pain.
We have added the Fascial Manipulation to prove if it make a faster recovery and a pain reduction in the short and the middle term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study are evaluated in parallel against a control group.
| Arm | Type | Receives |
|---|---|---|
| Standard Group | Active comparator | Other: Standard exercises protocolThe subjects will be treated with a standard protocol of stretching and strengthening exercises , we require them to do the exercises by themselves during five weeks, one a day. To make sure that they will do the protocol, we'll give them a diary to sign the daily section. |
| Intervention group | Experimental | Other: Fascial ManipulationThe subjects will be treated with the same protocol of the Standard Group, but in two section, they will receive a Fascial Manipulation approach. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- shoulder pain and acute and relapse in six months
- positive results in two orthopedic testes
Key exclusion criteria (5 listed)
- Degenerative diseases and neurological diseases
- Rheumatological Diseases and cancer
- fracture of the humerus, scapula and collarbone
- documented injury of rotator cuff.
- cortisones therapy in action
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 |
|---|---|---|
| Fascial ManipulationFascial Manipulation is a manual therapy that focused on deep muscular fascial. | Other | Intervention group |
| Standard exercises protocolStretching and strengthening exercises | Other | Standard Group |
Primary outcome
Shoulder Pain
Time frame: Before and after the first treatment. A week after the enrollment.
VNS scale in the Apley 'Scratch Test
9 secondary outcomes
shoulder' function
Time frame: Before and after the first treatment. A week after the enrollment.
shoulder' function
Time frame: Before and after the fifth treatment, after five weeks. This will be the last treatment
shoulder' function
Time frame: A month later the last treatment, as follow up
Range of Movement of the shoulder
Time frame: Before and after the first treatment. A week after the enrollment.
Range of Movement of the shoulder
Time frame: Before and after the fifth treatment, after five weeks.This will be the last treatment
Range of Movement of the shoulder
Time frame: A month later the last treatment, as follow up
The shoulder's muscular strength
Time frame: Before and after the first treatment. A week after the enrollment.
The shoulder's muscular strength
Time frame: Before and after the fifth treatment, after five weeks. This will be the last treatment
The shoulder's muscular strength
Time frame: A month later the last treatment, as follow up
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 15 Feb 2022.
- 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.
Massimo Busato, first level study director
Azienda Ospedaliera Bolognini di Seriate Bergamo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Manipulation and Standard exercises protocol in people with Shoulder Pain and Manual Therapy, run by Azienda Ospedaliera Bolognini di Seriate Bergamo at 1 site in Italy.
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 2 inclusion and 5 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 15 Feb 2022. 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 Italy. 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?
Shoulder Pain (time frame: Before and after the first treatment. A week after the enrollment.). 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 15 Feb 2022.