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Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

Primary Purpose

Hemophilia

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy
Sponsored by
Investigación en Hemofilia y Fisioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemophilia

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients diagnosed with hemophilia A and B
  • With severe (<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia
  • Over 18 years
  • With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score
  • In prophylactic treatment with FVIII / FIX concentrates for coagulation

Exclusion Criteria:

  • Patients with inhibitors (antibodies against FVIII or FIX)
  • Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests
  • Failure to sign the informed consent document

Sites / Locations

  • University of Oviedo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemophilia group

Arm Description

Intervention protocol: Preparatory work: active mobilizations with the patient supine. Global passive mobilization of the forefoot and midfoot. Calcaneocuboid mobilization, functional and structural work of said joint. Astragaloscaphoid mobilization, functional and structural work of said joint. Talar manipulation dorsally. Manipulation-tibial displacement: Tibiotarsal decompression: 2 very gentle high-speed and short-course tibial-tarsal manipulations. Plantar fascia induction for foot captors of the plantar fascia. Tibiotarsal sustained traction technique (unwinding) Sural triceps induction technique:

Outcomes

Primary Outcome Measures

Change from baseline frequency of ankle hemarthrosis after treatment and at 2 months
Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.

Secondary Outcome Measures

Change from baseline ankle 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 ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
Change from baseline pressure pain threshold of ankle 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.
Change from baseline pressure pain threshold of ankle after treatment and at 2 months
Hemophilia Joint Health Score (HJHS). This measuring instrument will be used to evaluate the joint condition of ankles. 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).
Change from baseline ankle range of motion after treatment and at 2 months
Leg motion device. The test will be conducted in accordance with the procedures for conducting the weight-bearing lunge test. The subjects will stand to assess, in the Leg Motion system, with the big toe on the starting line and the knee touching a metal stick. While patients hold the position, they will be instructed on how to perform a lunge in which the knee will be flexed with the aim of touching a metal rod with its anterior part. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Maximum dorsiflexion ROM will be defined as the maximum distance from the toe to the metal rod while maintaining contact with the knee for three seconds, without lifting the heel. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot, first with one leg and then with the contralateral leg.

Full Information

First Posted
September 19, 2022
Last Updated
January 3, 2023
Sponsor
Investigación en Hemofilia y Fisioterapia
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1. Study Identification

Unique Protocol Identification Number
NCT05549843
Brief Title
Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
Official Title
Safety and Efficacy of Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
February 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Investigación en Hemofilia y Fisioterapia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception), intra-articular alterations and chronic pain. Manual therapy techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. Design. Case-control, pilot, and randomized clinical trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy. Patients: 100 patients with ankle arthropathy will be recruited for inclusion in the study. Patients will be recruited in seven centers, from different regions of Spain. Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the intervention, and after a follow-up period of 6 weeks. The treatment program includes 10 exercises that must be administered bilaterally. Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint pain); digital goniometer (ankle range of motion); Haemophilia Joint Health Score (joint health); dynamometer assess (muscle strength); 2 Minute Walk Test (functionality); and biomechanical gait evaluation. At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment. Expected results: To demonstrate the safety of this Physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health, strength, functionality and gait analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemophilia group
Arm Type
Experimental
Arm Description
Intervention protocol: Preparatory work: active mobilizations with the patient supine. Global passive mobilization of the forefoot and midfoot. Calcaneocuboid mobilization, functional and structural work of said joint. Astragaloscaphoid mobilization, functional and structural work of said joint. Talar manipulation dorsally. Manipulation-tibial displacement: Tibiotarsal decompression: 2 very gentle high-speed and short-course tibial-tarsal manipulations. Plantar fascia induction for foot captors of the plantar fascia. Tibiotarsal sustained traction technique (unwinding) Sural triceps induction technique:
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week over a period of 3 weeks. Each session is made up of 10 steps, of which 9 correspond to manual interventions commonly used in the field of manual therapy.
Primary Outcome Measure Information:
Title
Change from baseline frequency of ankle hemarthrosis after treatment and at 2 months
Description
Weekly follow-up by telephone calls in the experimental phase. The evaluator will conduct a survey with closed questions and answers on the clinical manifestations of hemarthrosis to rule out joint or muscle bleeding. The frequency of hemarthrosis will be measured with the total number of bleedings in the study period in each evaluation.
Time Frame
Screening visit, within the first seven days after treatment and after two months follow-up
Secondary Outcome Measure Information:
Title
Change from baseline ankle joint pain after treatment and at 2 months
Description
Visual analogic scale (VAS). This scale will be used to evaluate the perception of joint pain, where ankle joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).
Time Frame
Screening visit, within the first seven days after treatment and after two months follow-up
Title
Change from baseline pressure pain threshold of ankle after treatment and at 2 months
Description
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.
Time Frame
Screening visit, within the first seven days after treatment and after two months follow-up
Title
Change from baseline pressure pain threshold of ankle after treatment and at 2 months
Description
Hemophilia Joint Health Score (HJHS). This measuring instrument will be used to evaluate the joint condition of ankles. 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).
Time Frame
Screening visit, within the first seven days after treatment and after two months follow-up
Title
Change from baseline ankle range of motion after treatment and at 2 months
Description
Leg motion device. The test will be conducted in accordance with the procedures for conducting the weight-bearing lunge test. The subjects will stand to assess, in the Leg Motion system, with the big toe on the starting line and the knee touching a metal stick. While patients hold the position, they will be instructed on how to perform a lunge in which the knee will be flexed with the aim of touching a metal rod with its anterior part. The metal rod will move away from the foot up to the maximum ankle dorsiflexion allowed, without taking the heel off the ground and with knee contact on the rod. Maximum dorsiflexion ROM will be defined as the maximum distance from the toe to the metal rod while maintaining contact with the knee for three seconds, without lifting the heel. Three measurements will be made for each ankle and the mean value will be used for data analysis. All measurements will be made with the patient barefoot, first with one leg and then with the contralateral leg.
Time Frame
Screening visit, within the first seven days after treatment and after two months follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with hemophilia A and B With severe (<1% FVIII/FIX) or moderate (1-5% FVIII/FIX) phenotype of hemophilia Over 18 years With medical diagnosis of ankle arthropathy and with clinical evaluation by Hemophilia Joint Health Score In prophylactic treatment with FVIII / FIX concentrates for coagulation Exclusion Criteria: Patients with inhibitors (antibodies against FVIII or FIX) Patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests Failure to sign the informed consent document
Facility Information:
Facility Name
University of Oviedo
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

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