Cuff Rotator SyndromeNCT01888016
Effectiveness of Fascial Manipulation in Rotator's Cuff Surgery Patients
A study testing fascial manipulation and standard physiotherapies treatment in people with Cuff Rotator Syndrome, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to reduce pain and improve physical functionality after rotator's cuff surgery. The technique involves deep friction manipulation of fascia's specific spots. Distant from surgical site. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cuff Rotator Syndrome
- What is being tested?
- fascial manipulation and standard physiotherapies treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2013to Jun 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rotator's cuff surgery patients that have been operated within the past 4/5 weeks
- Age between 18 to 65 years old
Who cannot join
- Patients with traumatic shoulder's injury that involved bone's fractures.
- Severe underlying pathologies like rheumatic, neurological and cardio pathologies that affect the correct shoulder treatment
- Patients on anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Fascial Manipulation in Early Rehabilitation Treatment of Rotator's Cuff Surgery Patients. A Randomized Trial.
The purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to reduce pain and improve physical functionality after rotator's cuff surgery. The technique involves deep friction manipulation of fascia's specific spots. Distant from surgical site.
Read the detailed description
To evaluate the effectiveness of fascial manipulation treatment associated with standard physiotherapies treatment in rotator's cuff surgery patients, we'll randomize about 60 patients for arm's of study. Both arm's will receive 10 standard physiotherapies treatments in 2 weeks while the experimental arm will receive 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.
To evaluate the effectiveness of fascial manipulation treatment we'll use 2 type of outcome measure and we will compare the result of both arms of study.
- Conditions
- Cuff Rotator Syndrome
- Being tested
- fascial manipulation, standard physiotherapies treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascial manipulationOther
- 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.
standard physiotherapies treatmentOther
10 standard treatments in 2 weeks
- Deltoid and infraspinatus muscles electrotherapy
- Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day
- Scar massage
- Upper limb, cervical spine and scapula massages
- Passive and assisted/active shoulder mobilization exercises
- Scapula micro-mobilizations
- Gleno-humeral decoaptation
- Elbow, wrist and hand active mobilization
- Proprioceptive exercise with and without the aid of the mirror
| Study group | Role | What they receive |
|---|---|---|
| fascial manipulation | Experimental | Not described Receives: Other: fascial manipulation; Other: standard physiotherapies treatment |
| standard treatment | Active comparator | Not described Receives: Other: standard physiotherapies treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)mean
we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with follow up (30 days from surgery)
Measured: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
Secondary outcomes (1)
Constant Murley score
Constant Murley score for range of motion and shoulder function assessment.
Measured: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cuff Rotator SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Grazia Benedetti, MD, Study chair, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888016
- Sponsor's protocol ID
- Manifa
- Status last verified
- Aug 2015
- First submitted
- 25 Jun 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Fascial Manipulation in Early Rehabilitation Treatment of Rotator's Cuff Surgery Patients. A Randomized Trial.
- ClinicalTrials.gov ID
- NCT01888016
- Acronym / sponsor ID
- Manifa
- Conditions
- Cuff Rotator Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jun 2013 (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 purpose is to evaluate the effectiveness of fascial manipulation treatment in terms to reduce pain and improve physical functionality after rotator's cuff surgery. The technique involves deep friction manipulation of fascia's specific spots. Distant from surgical site.
Detailed description
To evaluate the effectiveness of fascial manipulation treatment associated with standard physiotherapies treatment in rotator's cuff surgery patients, we'll randomize about 60 patients for arm's of study. Both arm's will receive 10 standard physiotherapies treatments in 2 weeks while the experimental arm will receive 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.
To evaluate the effectiveness of fascial manipulation treatment we'll use 2 type of outcome measure and we will compare the result of both arms of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascial manipulation | Experimental | Other: fascial manipulation, Other: standard physiotherapies treatment |
| standard treatment | Active comparator | Other: standard physiotherapies treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Rotator's cuff surgery patients that have been operated within the past 4/5 weeks
- Age between 18 to 65 years old
Key exclusion criteria (3 listed)
- Patients with traumatic shoulder's injury that involved bone's fractures.
- Severe underlying pathologies like rheumatic, neurological and cardio pathologies that affect the correct shoulder treatment
- Patients on anticoagulant treatment
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 manipulation• 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration. | Other | fascial manipulation |
| standard physiotherapies treatment10 standard treatments in 2 weeks * Deltoid and infraspinatus muscles electrotherapy * Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day * Scar massage * Upper limb, cervical spine and scapula massages * Passive and assisted/active shoulder mobilization exercises * Scapula micro-mobilizations * Gleno-humeral decoaptation * Elbow, wrist and hand active mobilization * Proprioceptive exercise with and without the aid of the mirror | Other | fascial manipulation, standard treatment |
Primary outcome
visual analogue scale (VAS)mean
Time frame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)
we'll compare the baseline data (the first evaluation), with data at the end of the treatment, and with follow up (30 days from surgery)
1 secondary outcome
Constant Murley score
Time frame: Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)
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 20 Nov 2015.
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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.
Maria Grazia Benedetti, MD study chair
Istituto Ortopedico Rizzoli
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 physiotherapies treatment in people with Cuff Rotator Syndrome, run by Istituto Ortopedico Rizzoli 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 3 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 20 Nov 2015. 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?
visual analogue scale (VAS)mean (time frame: Change from baseline in pain at the end of the rehabilitation cycle (two weeks)). 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 20 Nov 2015.