Manual Therapy in Hemophilic Arthropathy of the Ankle

NCT06816056 | Recruiting

• 1 other identifier: HE-ANKLEran
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Haemophilic ankle arthropathy manifests as functional (deficit in muscle strength, mobility and proprioception), intra-articular degenerative alterations and chronic pain. Manual therapy techniques are characterised by treating the soft tissues with the aim of modifying their density, relieving pain, reducing tissue sensitivity and improving the ranges of mobility. The objective is to evaluate the safety and effectiveness of a manual therapy protocol in patients with haemophilic ankle arthropathy. Methods: Randomised crossover clinical trial. 13 patients with haemophilic ankle arthropathy from different regions of Spain will be recruited and randomised into two study groups (experimental and control). Each session of the experimental group will last 50 minutes, with 1 physiotherapy session per week for a period of 3 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 4 weeks. The treatment programme includes 10 techniques that must be administered bilaterally. The study variables are the frequency of ankle haemarthrosis, range of movement, pressure pain threshold, pain intensity, joint status, biomechanical analysis of gait and balance, functionality and kinesiophobia. Expected results: To evaluate the safety of manual therapy in patients with haemophilia. To observe changes in pain, mobility, joint condition, stability and functionality of the ankle, and kinesiophobia.

Conditions

Hemophilia A

Keywords

Hemophilic arthropathy; Ankle; Manual therapy; Joint pain

Outcome Measures

Primary Outcomes (1)

• Change from baseline hemarthrosis after treatment and at four weeks

  A self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

Secondary Outcomes (6)

• Change from baseline pressure pain threshold after treatment and at four weeks

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

• Change from baseline joint status after treatment and at four weeks

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

• Change from baseline range of motion after treatment and at four weeks

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

• Change from baseline joint pain after treatment and at four weeks

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

• Change from baseline functional capacity after treatment and at four weeks

  Screening visit, within the first seven days after treatment and after four weeks follow-up visit

Study Arms (2)

Experimental group

EXPERIMENTAL

The intervention will last 3 weeks, with a periodicity of 1 weekly sessions. In total there will be 3 sessions lasting 50 minutes. The techniques will be: global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding traction technique and triceps surae induction technique

Other: Manual Therapy

Control group

PLACEBO COMPARATOR

The patients included in the control group will receive the same physiotherapy intervention in the form of a placebo. The physiotherapist in charge of this intervention will perform the same number of techniques but without applying sliding stimuli, myofascial induction or manipulation. The hands will be positioned in the same way and the times per technique will be the same as in the techniques of the experimental group.

Other: Placebo

Interventions

Manual Therapy OTHER

The patients included in the experimental group will receive a 50-minute physiotherapy intervention involving global passive mobilisation, calcaneocuboid mobilisation, talus-navicular mobilisation, talar manipulation, tibial displacement manipulation, tibiotarsal decompression, plantar fascia induction, tibiotarsal unwinding and triceps surae induction techniques

Experimental group

Placebo OTHER

The patients included in the control group will receive a 50-minute physiotherapy intervention in which the physiotherapist's hands and the times per technique will be the same as in the experimental group, but without applying any sliding, mobilisation or manipulation

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with haemophilia A and B
• With severe haemophilia phenotype (\<1% FVIII/FIX)
• Over 18 years of age
• With a medical diagnosis of ankle arthropathy and with clinical assessment using the Hemophilia Joint Health Score
• On prophylactic or on-demand treatment with coagulation factor VIII/FIX concentrates

You may not qualify if:

• Patients with neurological or cognitive disorders that prevent them from understanding the questionnaires and physical tests
• Failure to sign the informed consent document

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

Universidad Católica San Antonio

Murcia, Spain

RECRUITING

MeSH Terms

Conditions

Hemophilia A; Arthralgia

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Oviedo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

607547274; cuestaruben@uniovi.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 10, 2025
• Study Start: February 5, 2025
• Primary Completion: July 21, 2025
• Study Completion: July 25, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)