OsteoarthritismanifahipNCT02305108
Fascial Manipulation in Patients With Hip Osteoarthritis
A study testing fascial manipulation and standard treatment in people with Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. The fascial manipulation provides a deep pressure of specific points of the muscle fascia. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- fascial manipulation and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients age 40-80, with primary coxarthrosis waiting for total hip arthroplasty that complain a pain measured by Numeric Rating Scale ≥ 5 and that live in Bologna
Who cannot join
- arthroplasty revision or substitution. Patient with cognitive deficiency and severe comorbidity (rheumatic, neurological or cardiovascular pathology)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Treatment of the Soft Tissues With Fascial Manipulation for Patients That Are Waiting for Total Hip Arthroplasty in Osteoarthritis
The study will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. The fascial manipulation provides a deep pressure of specific points of the muscle fascia. The aims of this treatment are the improve of pain before the surgery and the improve of functional performance after the surgery.
- Conditions
- Osteoarthritis
- Being tested
- fascial manipulation, standard treatment
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascial manipulationOther
Recruited patients in study's group will be treated with the standard treatment and fascial manipulation.
Specific points of fascial tissue will be treated with a deep friction to improve elasticity.
The number of point treated will be refered to a specific evaluation for each patient.
Fascial manipulation provide 3 session treatment (one treatment for week).
standard treatmentOther
Before surgery, standard physiotherapy treatment provides an education session about the rehabilitation program tha is going to be execute after surgery.
After surgery 2 daily physiotherapy treatment are implemented: bed exercise as active and passive flex-extension of lower limb, movements for postural change to reach sitting and standing position, walking training.
| Study group | Role | What they receive |
|---|---|---|
| fascial manipolation and standard | Experimental | Not described Receives: Other: fascial manipulation; Other: standard treatment |
| standard treatment | Active comparator | Not described Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain is measured by numeric rating scale
Measured: 3 weeks before surgery
Secondary outcomes (1)
performance measurement assessed with Oxford Hip Scale, 30 second chair stand test, 10 meters walking test, Iova level of assistance.
Measured: a month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJun 2014
- 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 OsteoarthritisStudies 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
- Andrea Cotti, PT, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305108
- Sponsor's protocol ID
- Prot. gen. 0018810
- Acronym
- manifahip
- Status last verified
- Aug 2015
- First submitted
- 30 Sep 2014
- 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
- Evaluation of the Efficacy of Treatment of the Soft Tissues With Fascial Manipulation for Patients That Are Waiting for Total Hip Arthroplasty in Osteoarthritis
- ClinicalTrials.gov ID
- NCT02305108
- Acronym / sponsor ID
- manifahip / Prot. gen. 0018810
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Dec 2014 (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 will test the efficacy of the treatment of soft tissues for osteoarthritis patients that are waiting for total hip arthroplasty. The fascial manipulation provides a deep pressure of specific points of the muscle fascia. The aims of this treatment are the improve of pain before the surgery and the improve of functional performance after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascial manipolation and standard | Experimental | Other: fascial manipulation, Other: standard treatment |
| standard treatment | Active comparator | Other: standard treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients age 40-80, with primary coxarthrosis waiting for total hip arthroplasty that complain a pain measured by Numeric Rating Scale ≥ 5 and that live in Bologna
Key exclusion criteria (1 listed)
- arthroplasty revision or substitution. Patient with cognitive deficiency and severe comorbidity (rheumatic, neurological or cardiovascular pathology)
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 manipulationRecruited patients in study's group will be treated with the standard treatment and fascial manipulation. Specific points of fascial tissue will be treated with a deep friction to improve elasticity. The number of point treated will be refered to a specific evaluation for each patient. Fascial manipulation provide 3 session treatment (one treatment for week). | Other | fascial manipolation and standard |
| standard treatmentBefore surgery, standard physiotherapy treatment provides an education session about the rehabilitation program tha is going to be execute after surgery. After surgery 2 daily physiotherapy treatment are implemented: bed exercise as active and passive flex-extension of lower limb, movements for postural change to reach sitting and standing position, walking training. | Other | fascial manipolation and standard, standard treatment |
Primary outcome
pain is measured by numeric rating scale
Time frame: 3 weeks before surgery
1 secondary outcome
performance measurement assessed with Oxford Hip Scale, 30 second chair stand test, 10 meters walking test, Iova level of assistance.
Time frame: a month after surgery
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.
Andrea Cotti, PT principal investigator
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 treatment in people with Osteoarthritis, 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 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 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?
pain is measured by numeric rating scale (time frame: 3 weeks before surgery). 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.