HemophiliaHeL-FascialNCT03009591
Fascial Therapy in Elbow Hemophilic Arthropathy
A study testing Experimental group in people with Hemophilia, run by Real Fundación Victoria Eugenia at 1 site in Spain.
Trial summary
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2018to 15 Feb 2019
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with hemophilia A and B
- Patients adults (over 18 years)
- Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
- Patients pn prophylactic treatment with FVIII / FIX concentrates.
Who cannot join
- Patients without ambulation ability
- Patients with inhibitors
- Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
- Patients who have not signed the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.
Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.
Read more
Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.
Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.
- Conditions
- Hemophilia
- Being tested
- Experimental group
- Keywords
- Hemophilia, Elbow, Arthropathy, Joint pain, Range of motion, Myofascial techniques, Safety patients, Quality of life, Functionality
- Medical subject headings
- Hemophilia A, Joint Diseases, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Also called Fascial therapy group
Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.
- Transverse sliding of the flexor muscles of the wrist and fingers.
- Transverse sliding for the biceps brachii muscle.
- Longitudinal surface sliding over the superficial fascia in the posterior arm region.
- Transverse sliding over the brachial triceps tendon.
- Transverse sliding for the pectoralis major muscle.
- Transverse sliding for the posterior axillary region pectoralis major muscle.
- Induction of the posterior axillary fold.
- Induction (crossed hands over the brachial region and forearm).
- Maneuver of transverse planes for the cervicothoracic region.
- Upper limb telescopic maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Expermiental group | Experimental | All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally: Receives: Other: Experimental group |
| Control group | No intervention | Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline elbow joint bleeding frequency after treatment and at 3 months
After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Secondary outcomes (5)
Change from baseline range of motion of elbow after treatment and at 3 months
Change from range of movement of elbow during treatment and follow-up period at 3 months. The range of motion of the elbow joint will be measured using a universal goniometer, using the protocol for measuring joint motion described by Felipe Querol.
Measurement instrument: universal goniometer with the protocol to measurement for patients with hemophilia
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline elbow joint status after treatment and at 3 months
Change from elbow joint status during treatment and follow-up period at 3 months. Measurement instrument: Haemophilia Joint Health Score (scale 0-20).
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline joint pain of elbow after treatment and at 3 months
Change from joint pain of ankle during treatment and follow-up period at 3 months.The perception of ankle pain will be measured using visual analog scale (scale 0-10).
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline upper limb functionality after treatment and at 3 months
Change from upper limb functionality during treatment and follow-up period at 3 months. The perception of ankle pain will be measured using DASH Questionnaire. The Spanish version of this scale used internationally will evaluate upper limb functionality.
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline quality of life after treatment and at 3 months
Change from quality of life during treatment and follow-up period at 3 months. The quality of life perception will be measured using SF-36 Questionnaire. This scale will assess the perception of quality of life of patients included in the study.
Measured: Screening visit, within the first seven days after treatment and after three months follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start12 Feb 2018
- Primary completion1 Dec 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Fundación Victoria Eugenia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubén Cuesta-Barriuso, PhD, Real Fundación Victoria Eugenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009591
- Sponsor's protocol ID
- HeL-Fascial
- Acronym
- HeL-Fascial
- Status last verified
- Feb 2019
- First submitted
- 30 Dec 2016
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cuesta-Barriuso R, Merono-Gallut J, Donoso-Ubeda E, Lopez-Pina JA, Perez-Llanes R. Effect of a Fascial Therapy Treatment on Quality of Life in Patients With Hemophilic Elbow Arthropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 May;103(5):867-874. doi: 10.1016/j.apmr.2021.12.023. Epub 2022 Jan 23.
PubMed 35081366Cuesta-Barriuso R, Perez-Llanes R, Lopez-Pina JA, Donoso-Ubeda E, Merono-Gallut J. Manual therapy reduces the frequency of clinical hemarthrosis and improves range of motion and perceived disability in patients with hemophilic elbow arthropathy. A randomized, single-blind, clinical trial. Disabil Rehabil. 2022 Jul;44(15):3938-3945. doi: 10.1080/09638288.2021.1894607. Epub 2021 Mar 8.
PubMed 33684015
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03009591
- Acronym / sponsor ID
- HeL-Fascial / HeL-Fascial
- Conditions
- Hemophilia
- Keywords
- Hemophilia, Elbow, Arthropathy, Joint pain, Range of motion, Myofascial techniques, Safety patients, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Real Fundación Victoria EugeniaUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 4 Jan 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.
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.
Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.
Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.
Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expermiental group | Experimental | Other: Experimental groupAll patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally: |
| Control group | No intervention | –Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with hemophilia A and B
- Patients adults (over 18 years)
- Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
- Patients pn prophylactic treatment with FVIII / FIX concentrates.
Key exclusion criteria (4 listed)
- Patients without ambulation ability
- Patients with inhibitors
- Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
- Patients who have not signed the informed consent document.
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 |
|---|---|---|
| Experimental groupAlso: Fascial therapy groupLongitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes. * Transverse sliding of the flexor muscles of the wrist and fingers. * Transverse sliding for the biceps brachii muscle. * Longitudinal surface sliding over the superficial fascia in the posterior arm region. * Transverse sliding over the brachial triceps tendon. * Transverse sliding for the pectoralis major muscle. * Transverse sliding for the posterior axillary region pectoralis major muscle. * Induction of the posterior axillary fold. * Induction (crossed hands over the brachial region and forearm). * Maneuver of transverse planes for the cervicothoracic region. * Upper limb telescopic maneuver. | Other | Expermiental group |
Primary outcome
Change from baseline elbow joint bleeding frequency after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.
5 secondary outcomes
Change from baseline range of motion of elbow after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline elbow joint status after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline joint pain of elbow after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline upper limb functionality after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
Change from baseline quality of life after treatment and at 3 months
Time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit
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 26 Feb 2019.
- Derived from this study: PubMed 35081366Cuesta-Barriuso R, Merono-Gallut J, Donoso-Ubeda E, Lopez-Pina JA, Perez-Llanes R. Effect of a Fascial Therapy Treatment on Quality of Life in Patients With Hemophilic Elbow Arthropathy: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 May;103(5):867-874. doi: 10.1016/j.apmr.2021.12.023. Epub 2022 Jan 23.
- Derived from this study: PubMed 33684015Cuesta-Barriuso R, Perez-Llanes R, Lopez-Pina JA, Donoso-Ubeda E, Merono-Gallut J. Manual therapy reduces the frequency of clinical hemarthrosis and improves range of motion and perceived disability in patients with hemophilic elbow arthropathy. A randomized, single-blind, clinical trial. Disabil Rehabil. 2022 Jul;44(15):3938-3945. doi: 10.1080/09638288.2021.1894607. Epub 2021 Mar 8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Hemophilia, run by Real Fundación Victoria Eugenia 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 4 inclusion and 4 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 26 Feb 2019. 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 elbow joint bleeding frequency after treatment and at 3 months (time frame: Screening visit, within the first seven days after treatment and after three months follow-up visit). 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 NCT03009591, which also lists 2 linked publications.
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 26 Feb 2019.