Patients With HaemophiliaARTHROPANCT02198014
Manual Therapy in Haemophilic Arthropathy of the Knee
A study testing Manual Therapy and Educational Physiotherapy in people with Patients With Haemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Patients With Haemophilia
- What is being tested?
- Manual Therapy and Educational Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Jun 2014
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be over the age of 18 years
- Diagnosis of haemophilia A or B
- Patients with haemophilic arthropathy in one or both knees
Who cannot join
- Patients who had a haemarthrosis of knee during intervention
- Patients with different medical diagnosis (eg, Von Willebrand's disease)
- Patients with antibodies to FVIII or FIX (inhibitors).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study
This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia and arthropathy of the knee.
Read the detailed description
Randomized trial with two treatment groups: one using joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises (group MT); and another with educational sessions and home exercises (group E); and a control group (group C).
The intervention was carried out during twelve weeks, performing evaluation before and after treatment, and six months of finalizing this. The treatment in MT group consisted of two sessions per week for one hour each, and the treatment in group E consisted of a session of 90 minute every two weeks, with exercises daily home. The control group (group C) did not receive any treatment. After the allocation to the groups, the composition was follows: MT group = 7; E group = 7; and control group = 7.
- Conditions
- Patients With Haemophilia
- Being tested
- Manual Therapy, Educational Physiotherapy
- Keywords
- Knee, Joint disease, Haemophilia, Physiotherapy modalities
- Medical subject headings
- Joint Diseases, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.
10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.
10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.
10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.
10 minutes. Local cryotherapy with ice pack.
Educational PhysiotherapyOther
- Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy group | Experimental | We employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each. Receives: Other: Manual Therapy |
| Educational gruop | Experimental | This group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception.
Each educational session of 90 minute every two weeks, with exercises daily home Receives: Other: Educational Physiotherapy |
| Control group | No intervention | The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the range of movement (ROM)
Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in quadriceps muscle circumference
Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in muscle strength of quadriceps
Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in the perception of pain
Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in the assessment of radiological joint deterioration
We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Secondary outcomes (2)
Subjects' physical characteristics
Age of patient (years), Weight of patient (kg), Number of ankle haemarthrosis in previous year, Type of haemophilia (A or B), Severity of haemophilia (severe or moderate), Treatment (prophylaxis or on demand).
Measured: Screening visit (pretreatment assessment)
Changes in the frequency of knee hemarthrosis
Evaluation of knee bleeding before, during and after physiotherapy treatment. Hemarthrosis must be diagnosed clinically.
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionJun 2014
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 Patients With 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUBÉN CUESTA-BARRIUSO, Universidad Católica San Antonio de Murcia
- Investigators
- RUBEN CUESTA-BARRIUSO, PhD, Principal investigator, Universidad Católica San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198014
- Sponsor's protocol ID
- ARTHROPATHY
- Other IDs
- ARTHROPAT
- Acronym
- ARTHROPA
- Status last verified
- Jun 2014
- First submitted
- 21 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cuesta-Barriuso R, Torres-Ortuno A, Nieto-Munuera J, Lopez-Pina JA. Effectiveness of an Educational Physiotherapy and Therapeutic Exercise Program in Adult Patients With Hemophilia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):841-848. doi: 10.1016/j.apmr.2016.10.014. Epub 2016 Nov 16.
PubMed 27865846
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Manual Therapy and Educational Physiotherapy in the Treatment of Hemophilic Arthropathy of the Knee. A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02198014
- Acronym / sponsor ID
- ARTHROPA / ARTHROPATHY
- Conditions
- Patients With Haemophilia
- Keywords
- Knee, Joint disease, Haemophilia, Physiotherapy modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Jul 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.
This study aims to assess the effectiveness of two Physiotherapy treatments: one with manual therapy using joint traction, passive muscle stretching, and isometric exercise, active resisted and proprioception exercises; and other treatment with educational sessions and home exercises to improve the ROM, muscle strength and proprioception in patients with haemophilia and arthropathy of the knee.
Detailed description
Randomized trial with two treatment groups: one using joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises (group MT); and another with educational sessions and home exercises (group E); and a control group (group C).
The intervention was carried out during twelve weeks, performing evaluation before and after treatment, and six months of finalizing this. The treatment in MT group consisted of two sessions per week for one hour each, and the treatment in group E consisted of a session of 90 minute every two weeks, with exercises daily home. The control group (group C) did not receive any treatment. After the allocation to the groups, the composition was follows: MT group = 7; E group = 7; and control group = 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy group | Experimental | Other: Manual TherapyWe employed joint traction, passive muscle stretching and isometric exercises, active resisted and proprioception exercises. The treatment in this group consisted of two sessions per week for one hour each. |
| Educational gruop | Experimental | Other: Educational PhysiotherapyThis group received educational sessions and home exercises. The exercises are aimed at improving quadriceps strength, flexibility, range of motion and knee proprioception. Each educational session of 90 minute every two weeks, with exercises daily home |
| Control group | No intervention | –The control group (group C) did not receive any treatment. The patients of this group were assessed by the same reviewers and under the same conditions as the subjects of the two intervention groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must be over the age of 18 years
- Diagnosis of haemophilia A or B
- Patients with haemophilic arthropathy in one or both knees
Key exclusion criteria (3 listed)
- Patients who had a haemarthrosis of knee during intervention
- Patients with different medical diagnosis (eg, Von Willebrand's disease)
- Patients with antibodies to FVIII or FIX (inhibitors).
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 |
|---|---|---|
| Manual Therapy5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension. 10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle. 10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension. 10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization. 10 minutes. Local cryotherapy with ice pack. | Other | Manual Therapy group |
| Educational Physiotherapy* Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits. * Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique. | Other | Educational gruop |
Primary outcome
Changes in the range of movement (ROM)
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement of knee flexion and extension using a universal goniometer. Were taken as anatomical references, are indicated by Querol et al, using the reference method 0 to the mobile arm of the goniometer, as noted Norkin et al.
Changes in quadriceps muscle circumference
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement in the thigh, in two thirds of the flow distance between the anterior superior iliac spine and the joint line of the knee, using a tape measure
Changes in muscle strength of quadriceps
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measured by the rupture test for hemophilia patients (with a gradation of 0 to 5 points, with 0 indicating normal strength and 5 is the absence of muscle contraction).
Changes in the perception of pain
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Using the visual analog scale, VAS, consisting of a gradation of 0 to 10 points (from no pain to worst pain imaginable).
Changes in the assessment of radiological joint deterioration
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
We use the Petterson scale which consists of 13 items (0 indicates a normal joint and joint deterioration 13 maximum).
2 secondary outcomes
Subjects' physical characteristics
Time frame: Screening visit (pretreatment assessment)
Changes in the frequency of knee hemarthrosis
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
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 23 Jul 2014.
- Derived from this study: PubMed 27865846Cuesta-Barriuso R, Torres-Ortuno A, Nieto-Munuera J, Lopez-Pina JA. Effectiveness of an Educational Physiotherapy and Therapeutic Exercise Program in Adult Patients With Hemophilia: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 May;98(5):841-848. doi: 10.1016/j.apmr.2016.10.014. Epub 2016 Nov 16.
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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.
RUBEN CUESTA-BARRIUSO, PhD principal investigator
Universidad Católica San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Educational Physiotherapy in people with Patients With Haemophilia, run by Universidad Católica San Antonio de Murcia 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 3 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 23 Jul 2014. 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?
Changes in the range of movement (ROM) (time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)). The study lists 5 primary outcomes in all. 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 NCT02198014, 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 23 Jul 2014.