ArthritisNCT02576028
Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty
A study testing Fascial Manipulation® (FM) and standard active exercises in people with Arthritis, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
Trial summary
Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- Fascial Manipulation® (FM) and standard active exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jul 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- first THA surgery,
- posterior-lateral access,
- onset of pain of maximum 2 years
Who cannot join
- patients with previous hip or knee prosthesis,
- congenital hip dysplasia,
- revision THA,
- elective THA secondary to trauma,
- real leg-length discrepancy (≥1.5cm),
- cognitive impairment,
Show all 9Show fewer
- concomitant rheumatic pathology in acute phase,
- serious comorbidities including cardiac,
- respiratory and/or neuromuscular pathologies.
About this study
Official title: Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty: a Randomized Controlled Trial.
Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.
Read the detailed description
Background. Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.
Methods. Fifty-one subjects operated with THA were randomized into two groups, both followed a standard protocol of care where two sessions were replaced with Fascial Manipulation in the study group. Functional outcomes measures collected before and after treatment and at the end of the rehabilitation program included Harris Hip Score, Time Up and Go test, articular range of motion and verbal numerical scale.
- Conditions
- Arthritis
- Being tested
- Fascial Manipulation® (FM), standard active exercises
- Keywords
- Total Hip Replacement, Manipulation Therapy
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial Manipulation® (FM)Other
Fascial Manipulation® (FM) is a manual therapy that focus on the deep muscular fascia. This technique considers the fascia as a three-dimensional continuum. The mainstay of this manual technique lies in the identification of specific localised areas of the fascia, defined Center of Coordination (CC), where the gliding of the subcutis should be preserved to avoid biomechanical in-coordination of the surrounding muscles. The method is performed by applying a deep friction over the CCs that result more altered at the clinical palpation
standard active exercisesOther
two sessions of 45 minutes of active exercises
| Study group | Role | What they receive |
|---|---|---|
| standard treathment | Other | two sessions of 45 minutes of active exercises for 10 days Receives: Other: standard active exercises |
| FM associated to standard treathment | Experimental | the same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment. Receives: Other: Fascial Manipulation® (FM); Other: standard active exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain during movement
value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale
Measured: change from before and after the 2nd day treatment, change from before and after the 7nd day treatment, change from 2nd and 10th day (end of study)
Secondary outcomes (3)
Range of motion (ROM)
hip ROM amplitude, measured with bobble inclinometer
Measured: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Harris Hip Score
Functional outcome
Measured: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Timed up and Go test (TuG)
functional test for stand up and walk speed
Measured: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies 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
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate Bergamo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576028
- Sponsor's protocol ID
- U1111-1173-0402
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Busato M, Quagliati C, Magri L, Filippi A, Sanna A, Branchini M, Marchand AM, Stecco A. Fascial Manipulation Associated With Standard Care Compared to Only Standard Postsurgical Care for Total Hip Arthroplasty: A Randomized Controlled Trial. PM R. 2016 Dec;8(12):1142-1150. doi: 10.1016/j.pmrj.2016.04.007. Epub 2016 May 19.
PubMed 27210234
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascial Manipulation® Associated With Standard Care Versus Standard Post-surgical Care for Total Hip Arthroplasty: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02576028
- Acronym / sponsor ID
- U1111-1173-0402
- Conditions
- Arthritis
- Keywords
- Total Hip Replacement, Manipulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Bolognini di Seriate BergamoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Oct 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.
Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.
Detailed description
Background. Post-surgical physiotherapy programs following to total hip arthroplasty (THA) show important differences between types and numbers of treatment sessions. Objectives are to investigate effectiveness of Fascial Manipulation when associated to a standard protocol of care.
Methods. Fifty-one subjects operated with THA were randomized into two groups, both followed a standard protocol of care where two sessions were replaced with Fascial Manipulation in the study group. Functional outcomes measures collected before and after treatment and at the end of the rehabilitation program included Harris Hip Score, Time Up and Go test, articular range of motion and verbal numerical scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treathment | Other | Other: standard active exercisestwo sessions of 45 minutes of active exercises for 10 days |
| FM associated to standard treathment | Experimental | Other: Fascial Manipulation® (FM), Other: standard active exercisesthe same intervention of CG except on days 2 and 7 where one session treatment was replaced with a FM treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- first THA surgery,
- posterior-lateral access,
- onset of pain of maximum 2 years
Key exclusion criteria (9 listed)
- patients with previous hip or knee prosthesis,
- congenital hip dysplasia,
- revision THA,
- elective THA secondary to trauma,
- real leg-length discrepancy (≥1.5cm),
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® (FM)Fascial Manipulation® (FM) is a manual therapy that focus on the deep muscular fascia. This technique considers the fascia as a three-dimensional continuum. The mainstay of this manual technique lies in the identification of specific localised areas of the fascia, defined Center of Coordination (CC), where the gliding of the subcutis should be preserved to avoid biomechanical in-coordination of the surrounding muscles. The method is performed by applying a deep friction over the CCs that result more altered at the clinical palpation | Other | FM associated to standard treathment |
| standard active exercisestwo sessions of 45 minutes of active exercises | Other | FM associated to standard treathment, standard treathment |
Primary outcome
change of pain during movement
Time frame: change from before and after the 2nd day treatment, change from before and after the 7nd day treatment, change from 2nd and 10th day (end of study)
value of pain during a specific movement , measured with Visual Numeric Scale (VNS) scale
3 secondary outcomes
Range of motion (ROM)
Time frame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Harris Hip Score
Time frame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
Timed up and Go test (TuG)
Time frame: before and after the 2nd day treatment, before and after the 7nd day treatment, 10th day (end of study)
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 22 Oct 2015.
- Derived from this study: PubMed 27210234Busato M, Quagliati C, Magri L, Filippi A, Sanna A, Branchini M, Marchand AM, Stecco A. Fascial Manipulation Associated With Standard Care Compared to Only Standard Postsurgical Care for Total Hip Arthroplasty: A Randomized Controlled Trial. PM R. 2016 Dec;8(12):1142-1150. doi: 10.1016/j.pmrj.2016.04.007. Epub 2016 May 19.
Related trials for Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fascial Manipulation® (FM) and standard active exercises in people with Arthritis, run by Azienda Ospedaliera Bolognini di Seriate Bergamo.
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 9 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 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 of pain during movement (time frame: change from before and after the 2nd day treatment, change from before and after the 7nd day treatment, change from 2nd and 10th day (end of study)). 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 NCT02576028, which also lists 1 linked publication.
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 22 Oct 2015.