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Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.
Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.
Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.
Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.
Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).
Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The patients included in the experimental group will receive a session of manual physiotherapy using joint gliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints. The intervention will be performed on both ankles. |
|
| Control group | Placebo Comparator | Patients included in the control group will receive a placebo manual physical therapy session, simulating joint sliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints, without any stimulus other than the pressure exerted by the physical therapist with his hands when mobilizing the foot. The placebo intervention will be performed on both ankles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual therapy | Other | Each session will last approximately 50-60 minutes. Each session is composed of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to the criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline sonographic changes after 4 hours | Ultrasound changes will be measured with the Haemophilia Early Arthropathy Detection with UltraSound score. This scale evaluates two parameters: i) inflammatory activity (scores synovial hypertrophy from 0 to 2 points depending on whether involvement is identified); and ii) involvement of articular surfaces (assesses articular cartilage and bone involvement). In the assessment of articular cartilage, a score from 0 to 4 is established (0: normal; 4: complete destruction of cartilage or cannot be visualized). Bone is scored from 0 to 2 points (0: normal; 2: involvement with osteophytes). | Screening visit and after four hours follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline joint pain after 4 hours | The intensity of ankle joint pain will be measured with the visual analog scale. This scale has shown moderate reliability (ICC: 0.60-0.77) in patients with chronic musculoskeletal pain. Its scores range from 0 to 10 points (from no pain to the maximum pain perceived by the patient). | Screening visit and after four hours follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubén Cuesta-Barriuso, PhD | Universidad de Oviedo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oviedo | Oviedo | Principality of Asturias | 33006 | Spain |
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| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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Randomization will be performed using a computerized randomization procedure by permuted blocks of 4 subjects in each recruitment center. The 6 possible sequence alternatives will be modified in each block. This task will be carried out by a person who is not involved in the study and who will not know the identity of the subjects.
|
| Placebo manual therapy | Other | Each session will last approximately 50-60 minutes. Each session consists of the placebo application of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. In the techniques there will be no joint sliding, manipulations or myofascial inductions, being the only stimulus the contact of the physiotherapist with his hands and the pressure exerted with these, on the ankle. |
|
| Change from baseline joint damage after 4 hours | Joint damage will be measured with the Hemophilia Joint Health Score (HJHS). This measurement instrument will be used to assess the joint status of both ankles. It includes 8 items (swelling and duration of swelling, pain, muscle atrophy and strength, crepitus, and loss of flexion and extension) with a range of 0 to 20 points per joint (the higher the score, the greater the joint impairment). | Screening visit and after four hours follow-up |
| Change from baseline degree of joint inflammation after 4 hours | With a doppler assessment, a qualitative assessment of the degree of joint inflammation (semi-quantitative visual scale from 1 to 4: none, mild, moderate, severe) and a quantitative assessment by quantifying the resistance index (RI) will be performed | Screening visit and after four hours follow-up |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |