Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle

NCT ID: NCT05549843

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2023-02-26

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. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol by manual therapy techniques in patients with hemophilic ankle arthropathy.

Patients: 24 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 3 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); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health). 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 and pressure pain threshold.

Conditions

Hemophilia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Hemophilia group

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:

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: OTHER

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.

Interventions

Manual therapy

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oviedo

Oviedo, Principality of Asturias, Spain

Countries

Spain

References

Truque-Diaz C, Merono-Gallut J, Cuesta-Barriuso R, Perez-Llanes R. Joint and Myofascial Manual Therapy Techniques in Haemophilic Ankle Arthropathy: A Randomized Pilot Study. Haemophilia. 2025 Mar;31(2):295-303. doi: 10.1111/hae.70002. Epub 2025 Feb 7.

Reference Type: DERIVED

PMID: 39917949 (View on PubMed)

Other Identifiers

He-AnklePilot

Identifier Type: -

Identifier Source: org_study_id