Self-myofascial Release With Foam Roller in Patients With Hemophilic Knee Arthropathy

NCT05108480 | Completed

• 1 other identifier: He-FoamKnee
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscular strength, mobility and proprioception) (intra-articular alterations) and chronic pain. Myofascial release techniques are used to treat soft tissue adhesions, relieve pain, and reduce tissue sensitivity. Design. A randomized clinical trial. Directed: To evaluate the safety and effectiveness of a myofascial self-release protocol with Foam Roller applied in patients with hemophilic knee arthropathy. Patients: 58 patients with knee arthropathy will be recruited for inclusion in the study. The patients will be recruited in 5 centers, from different regions of Spain. Intervention: Each session will last approximately 15 minutes, with five physical therapy sessions per week over a period of 8 weeks. Patients will be evaluated at the beginning of the study, after the intervention and after a follow-up period of 2 months. The treatment program includes 11 exercises to be administered bilaterally. A mobile application will be developed where each patient can observe the exercises to be performed. Measurement instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); Hemophilia Joint Health Score (Joint Condition); dynamometer evaluation (muscle strength); 6-minute walk test (lower extremity functionality); Mobile device (activity log); Finger floor test (muscle flexibility). At the same time, the study will make it possible to determine the joint bleeding caused by the applied physiotherapy treatment. Expected results: demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in ankle pain, function and joint movement is expected.

Conditions

Haemophilia

Outcome Measures

Primary Outcomes (1)

• Change from baseline knee 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 knee joint pain ranges from 0 to 10 points (no pain to maximum perceived pain).

  Screening visit, within the first seven days after treatment and after two months follow-up visit

Secondary Outcomes (6)

• Change from baseline knee pressure pain threshold after treatment and at 2 months

  Screening visit, within the first seven days after treatment and after two months follow-up visit

• Change from baseline knee joint status after treatment and at 2 months

  Screening visit, within the first seven days after treatment and after two months follow-up visit

• Change from baseline knee range of motion after treatment and at 2 months

  Screening visit, within the first seven days after treatment and after two months follow-up visit

• Change from baseline knee muscles strength after treatment and at 2 months

  Screening visit, within the first seven days after treatment and after two months follow-up visit

• Change from baseline muscle flexibility after treatment and at 2 months

  Screening visit, within the first seven days after treatment and after two months follow-up visit

Study Arms (2)

Self-myofascial release

EXPERIMENTAL

Each session will last approximately 15 minutes, with five physiotherapy sessions taking place over a period of 2 months. The Self-Myofascial release protocol for the lower limbs using a Foam Roller and and Solid Ball Massage, adapted to patients with hemophilic ankle arthropathy will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; Release of the myofascial components of the back of the leg using a Foam Roller; Release of the myofascial components of the anterior part of the leg using a Foam Roller; Release of myofascial components of the hamstring region using a Foam Roller; Release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; Release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; Release of the myofascial components of the pelvitrochanterian muscles using a Foam Roller in a sitting position.

Other: Experimental group

Control group

NO INTERVENTION

The subjects included in the control group will not receive Physiotherapy sessions and will continue with their usual routine of activity and physical exercise, and with the same drug treatment schedule with FVIII / FIX and analgesic drugs.

Interventions

Experimental group OTHER

This study followed the protocol designed for patients with hemophilic knee arthropathy. For its implementation, a 30-cm long15-cm diameter foam roller was used, and a ball 22 cm in length and 8 cm in diameter. The total duration of the intervention was 15 minutes, with 7 sessions per week over a period of 8 weeks. The physiotherapist who supervised the intervention followed up on all patients by telephone on a weekly basis to check for the absence of haemarthrosis during the intervention and to detect the possible need for protocol adaptations depending on the clinical situation of each patient. Each patient was individually provided with instructions as to how perform the exercises during the pretreatment evaluation, customizing the program if necessary. All patients had access to a mobile application, designed ad hoc for the research study (He-Foam®), where they could learn about the exercises through demonstration videos.

Self-myofascial release

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a medical diagnosis of hemophilia A or B.
• Patients with a severe phenotype of hemophilia (\<1% FVIII/FIX).
• Patients with a medical diagnosis of hemophilic knee arthropathy and more than 3 points on the Hemophilia Joint Health Score.
• Being over 18 years old.
• No scheduled orthopedic surgeries during the study phase

You may not qualify if:

• Patients with hemarthrosis in the month before the beginning of the study.
• Patients unable to walk.
• Severe functional alterations of the upper limb that prevented the exercises.
• Failure to sign the informed consent document

Sponsors & Collaborators

• Investigación en Hemofilia y Fisioterapia: lead

Study Sites (1)

University of Murcia

Murcia, 30006, Spain

Location

MeSH Terms

Conditions

Hemophilia A

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

Study Officials

• Rubén Cuesta-Barriuso, PhD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: October 26, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)