HaemophiliaNCT05108480
Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy
A study testing Experimental group in people with Haemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Haemophilia
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2021to 17 Feb 2022
- 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 with a medical diagnosis of hemophilia A or B.
- Patients with a severe phenotype of hemophilia (<1% FVIII/FIX).
- Patients with a medical diagnosis of hemophilic knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
- Being over 18 years old.
- No scheduled orthopedic surgeries during the study phase
Who cannot join
- Patients with hemarthrosis in the month before the beginning of the study.
- Patients unable to walk.
- Severe functional alterations of the upper limb that prevented the exercises.
- Failure to sign 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 Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy: A Randomized Clinical Trial
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity.
Design. A randomized clinical trial. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy.
Read more
Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain.
Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed.
Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment.
Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.
- Conditions
- Haemophilia
- Being tested
- Experimental group
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
This study followed the protocol designed for patients with hemophilic knee arthropathy. For its implementation, a 30-cm long15-cm diameter foam roller was used, and a ball 22 cm in length and 8 cm in diameter. The total duration of the intervention was 15 minutes, with 7 sessions per week over a period of 8 weeks. The physiotherapist who supervised the intervention followed up on all patients by telephone on a weekly basis to check for the absence of haemarthrosis during the intervention and to detect the possible need for protocol adaptations depending on the clinical situation of each patient. Each patient was individually provided with instructions as to how perform the exercises during the pretreatment evaluation, customizing the program if necessary. All patients had access to a mobile application, designed ad hoc for the research study (He-Foam®), where they could learn about the exercises through demonstration videos.
| Study group | Role | What they receive |
|---|---|---|
| Self-myofascial release | Experimental | Each session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 2 months. The Self-Myofascial release protocol for the lower limbs using a Foam Roller and and Solid Ball Massage, adapted to patients with hemophilic ankle arthropathy will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; Release of the myofascial components of the back of the leg using a Foam Roller; Release of the myofascial components of the anterior part of the leg using a Foam Roller; Release of myofascial components of the hamstring region using a Foam Roller; Release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; Release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; Release of the myofascial components of the pelvitrochanterian muscles using a Foam Roller in a sitting position. Receives: Other: Experimental group |
| Control group | No intervention | The subjects included in the control group will not receive Physiotherapy sessions and will continue with their usual routine of activity and physical exercise, and with the same drug treatment schedule with FVIII / FIX and analgesic drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline knee joint pain after treatment and at 2 months
Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where knee joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Secondary outcomes (6)
Change from baseline knee pressure pain threshold after treatment and at 2 months
Pressure algometer. Measuring instrument used to evaluate pressure joint pain. The instrument shall consist of a measuring device attached to a hard rubber tip 1.1 cm in diameter. Its sphere shall be calibrated in kg/cm2 with divisions of 0.1 kg/cm2. The pressure algometry methodology applied was based mainly on the study by Hogeweg. Before taking the measurements, patients will be instructed to say "yes" as soon as pressure exerted by the algometer becomes slightly unpleasant. The pressure algometer shall be kept perpendicular to the surface of the skin with the right hand, stabilizing the axis of the instrument using the thumb and index finger of the left hand. The pressure shall be increased at a uniform rate of approximately 1 kg/cm2 per second. As soon as the subject, according to the instructions, says "yes", the pressure will be stopped and the score will be noted.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline knee joint status after treatment and at 2 months
Hemophilia Joint Health Score (HJHS). This measuring instrument will be used to evaluate the joint condition of knees. It includes 8 items (inflammation and its duration, pain, atrophy and muscle strength, crepitus, and reduced flexion and extension) ranging from 0 to 20 points per joint (the higher the score, the greater the joint deterioration).
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline knee range of motion after treatment and at 2 months
Goniometry. Knee range of motion shall be measured using a goniometer. The assessment can be made with the patient standing. This measuring instrument allows more accurate measurements than those obtained with a universal goniometer
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline knee muscles strength after treatment and at 2 months
Dynamometry. The maximum isometric strength of the flexor and extensor muscles of the knee joint will be evaluated on both limbs with a manual dynamometer using a mark test. For this test, the rater needs to keep the dynamometer stationary while the patient exerts maximum force against it.
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline muscle flexibility after treatment and at 2 months
Fingertip-to-Floor Test. This test is used to assess the degree of flexibility of the posterior muscles of the lower limbs. This value is calculated as the distance between the fingertip and the floor when maximum hip flexion with knee extension is performed
Measured: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline of muscle activation of the quadriceps after treatment and at 2 months
Muscle activation of the quadriceps was evaluated with surface electromyography (surface electromyography model; Shimmer Sensing, Dublin, Ireland). Electrodes were placed accord-ing to the European recommendations for the use of surface electromyography. Bipo-lar rectangular silver/silver chloride (Ag/AgCl) electrodes were used, measuring 28 x 44 mm (Ambu® WhiteSensor 4200 model) with a 46 mm2 measurement area, 2 cm apart. For the patients to reach their maximum muscle strength, the rater provided the same verbal stimulus to motivate all the patients with each contraction.
Measured: Screening visit, within the first seven days after treatment and after two 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 posted5 Nov 2021
- Study start26 Oct 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies 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
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108480
- Sponsor's protocol ID
- He-FoamKnee
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2021
- Last updated
- 3 Mar 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 3 Mar 2022. 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 Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05108480
- Acronym / sponsor ID
- He-FoamKnee
- Conditions
- Haemophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- 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: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity.
Design. A randomized clinical trial. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy.
Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain.
Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed.
Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment.
Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-myofascial release | Experimental | Other: Experimental groupEach session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 2 months. The Self-Myofascial release protocol for the lower limbs using a Foam Roller and and Solid Ball Massage, adapted to patients with hemophilic ankle arthropathy will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; Release of the myofascial components of the back of the leg using a Foam Roller; Release of the myofascial components of the anterior part of the leg using a Foam Roller; Release of myofascial components of the hamstring region using a Foam Roller; Release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; Release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; Release of the myofascial components of the pelvitrochanterian muscles using a Foam Roller in a sitting position. |
| Control group | No intervention | –The subjects included in the control group will not receive Physiotherapy sessions and will continue with their usual routine of activity and physical exercise, and with the same drug treatment schedule with FVIII / FIX and analgesic drugs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a medical diagnosis of hemophilia A or B.
- Patients with a severe phenotype of hemophilia (<1% FVIII/FIX).
- Patients with a medical diagnosis of hemophilic knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
- Being over 18 years old.
- No scheduled orthopedic surgeries during the study phase
Key exclusion criteria (4 listed)
- Patients with hemarthrosis in the month before the beginning of the study.
- Patients unable to walk.
- Severe functional alterations of the upper limb that prevented the exercises.
- Failure to sign 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 groupThis study followed the protocol designed for patients with hemophilic knee arthropathy. For its implementation, a 30-cm long15-cm diameter foam roller was used, and a ball 22 cm in length and 8 cm in diameter. The total duration of the intervention was 15 minutes, with 7 sessions per week over a period of 8 weeks. The physiotherapist who supervised the intervention followed up on all patients by telephone on a weekly basis to check for the absence of haemarthrosis during the intervention and to detect the possible need for protocol adaptations depending on the clinical situation of each patient. Each patient was individually provided with instructions as to how perform the exercises during the pretreatment evaluation, customizing the program if necessary. All patients had access to a mobile application, designed ad hoc for the research study (He-Foam®), where they could learn about the exercises through demonstration videos. | Other | Self-myofascial release |
Primary outcome
Change from baseline knee joint pain after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where knee joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
6 secondary outcomes
Change from baseline knee pressure pain threshold after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline knee joint status after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline knee range of motion after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline knee muscles strength after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline muscle flexibility after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit
Change from baseline of muscle activation of the quadriceps after treatment and at 2 months
Time frame: Screening visit, within the first seven days after treatment and after two 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 3 Mar 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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad de Murcia
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 Haemophilia, run by Investigación en Hemofilia y Fisioterapia 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 5 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 3 Mar 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 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 knee joint pain after treatment and at 2 months (time frame: Screening visit, within the first seven days after treatment and after two months follow-up visit). 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 3 Mar 2022.