The Effects of Manual Therapy in Hemophilic Patients

The Effectiveness of Manual Theraphy on Lower Extremity Joint Arthropathy in Patients With Hemophilia

Uncertainty about how to treat existing hemophilic arthropathy (HA) is the most important issue that will increase functionality and joint health. Recent studies have shown that MT can be used safely for improving joint health, pain and ROM with no bleedings in PwH with elbow and ankle HA. Unlike MT studies in hemophilia, we investigated the effects of MT on important parameters such as muscle strength (MS), functional level, joint health, functional independence score in hemophilia (FISH) and kinesiophobia. These parameters are closely related to functional level and quality of life of PwH. Therefore, evaluation of these parameters and determining the effects of the MT on these parameters are very important for both PwH and also clinicians.

Study Overview

• Status: Completed
• Conditions: Hemophilia; Arthropathy Hemophilic
• Intervention / Treatment: Other: Manual therapy

Detailed Description

The aim of this study was to investigate the effects of manual therapy in addition to home exercise program on hemophilia functional independence level, joint health, kinesiophobia, functional level, range of motion, muscle strength and pain level in hemophilic individuals with lower extremity joint arthropathy. Hemophilic arthropathy was developed in at least one of the lower extremity joints and aged between 18-30 years 17 severe type hemophilic men were participated in the study. The participants were divided into two groups as Home Exercise Group (HEG) and Manual Therapy Group (MTG) by randomization method. While the HEG was performed the exercise program at home, in addition to the same HEG manual therapy were applied to the MTG by the same physiotherapist 3 days a week for 1 hour. Both groups were followed for a total of 5 weeks and pre-treatment evaluations were repeated post-treatment. The joint health of the hemophilics in both groups were evaluated with Hemophilia Joint Health Score (HJHS), their kinesiophobia level were evaluated with Tampa Kinesophobia Scale, their functionality with the Functional Independence Score in Hemophilia (FISH). In addition, Functional Reach, Timed Up and Go and 5 Times Sit-to- Stand tests were used for functional level. The range of motion was evaluated with a goniometer, muscle strength was measured with a digital dynamometer and pain level was assessed with a Visual Analogue Scale (VAS). Number of hemarthrosis decreased in both groups.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sarıcam
    • Adana, Sarıcam, Turkey, 01330
      • Cukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients with hemophilia who have arthropathy developed in any of the lower extremity joints due to severe hemophilia and to be receiving regular prophylaxis (3*1500 IU/ per week), but not having regular physical activity and sports.

Exclusion Criteria:

• Patients with hemophilia who had any disease related to connective tissue, any surgery that affects lower limb function (joint debridement, fracture, prosthesis), any neurological disease or cognitive impairment that may affect functional level, any sensorial loss of peripheral nerve injury and did not attend their sessions and evaluations regularly.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manual Therapy; The experienced physiotherapist has applied manual therapy (MT) to the arthropathic joints. MT was started with myofascial release techniques (MRT), then continued with mobilization techniques using Kalternborn. Superficial MRT consisted of 3 strokes, via manual movement on the tissue, encourage release of the superficial fascia. In the Kalternborn mobilization technique, Grade I-II mobilization was applied with traction without using a strap. The same exercises given to the home exercise group were given to the patients in this group as well.	Other: Manual therapy; Both groups received for 3 sessions per week, a total of 5 weeks. Home exercises were performed by the patient for 30 minutes at home.In home exercises active ROM for warm-up (5 min), passive stretchening (5 min), strengthening exercises (10 min), proprioceptive and balance exercises (10 min). In manual therapy group, myofascial release techniques (MRT) and Kalternborn mobilization techniques lasted about one hour. In MRT, each manuever was applied for 2 mins and 3 times. The superficial strokes were performed, assisted by slight movements of joints. MRT to posterior capsule of the knee, ligaments, iliotibial tractus, plantar fascia, metatarsal, tarsals, and toes. Kalterborb mobilization tecnqiues; posterior gliding for restricted knee flexion, anterior gliding for restricted knee extension,talocrural posteior gliding for dorsal flexion, talocrural anterior gliding for plantar flexion.3 * 10 repetitions, 20 sec of per reps and 10 sec of interval.; Other Names: Home exercise
ACTIVE_COMPARATOR: Home Exercise; The home exercises (HE) consisted of active ROM exercises, passive stretching exercises, progressive resistive exercises, weigh-bearing and stance exercises were performed by the patient for 30 minutes at home.	Other: Manual therapy; Both groups received for 3 sessions per week, a total of 5 weeks. Home exercises were performed by the patient for 30 minutes at home.In home exercises active ROM for warm-up (5 min), passive stretchening (5 min), strengthening exercises (10 min), proprioceptive and balance exercises (10 min). In manual therapy group, myofascial release techniques (MRT) and Kalternborn mobilization techniques lasted about one hour. In MRT, each manuever was applied for 2 mins and 3 times. The superficial strokes were performed, assisted by slight movements of joints. MRT to posterior capsule of the knee, ligaments, iliotibial tractus, plantar fascia, metatarsal, tarsals, and toes. Kalterborb mobilization tecnqiues; posterior gliding for restricted knee flexion, anterior gliding for restricted knee extension,talocrural posteior gliding for dorsal flexion, talocrural anterior gliding for plantar flexion.3 * 10 repetitions, 20 sec of per reps and 10 sec of interval.; Other Names: Home exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemophilia Joint Health Score	We used the index point of joints. Score ranged from 0 to 20. Low score indicates the good joint health	5 week
Functional Independence Score in Hemophilia	We used the functional independence of patients. Score ranged from 0 to 32. High score indicates the functional independence.	5 week
Tampa Kinesiophobia Scale	Score higher than 37 were associated with a high degree of kinesiophobia.	5 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Joint range was measured with a universal goniometer.	5 week
Muscle Strength	It was measured with hand-held dynamometer.	5 week
Numerical Pain Scale	It was used for assessment of activity and resting pain.	5 week
Frequency bleeding	It was evaluated from the diaries kept by the patients	5 week
Functional Reach	It was used to assess dynamic balance.	5 week
Timed Up and Go	It was used to evaluate functional mobility, dynamic balance, fall risk and postural stability.	5 week
5 Times Sit to Stand	It was evaluated the functional strength of lower extremity, transitive movements, balance and fall risk.	5 week

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Study Chair: Filiz CAN, Professor, Hacettepe University, Faculty of Physiotherapy and Rehabilitation; Study Director: Ilgen SASMAZ, Professor, Cukurova University; Study Director: Ali Bulent ANTMEN, Professor, Acıbadem Adana Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 12, 2018
• Primary Completion (ACTUAL): April 15, 2019
• Study Completion (ACTUAL): October 7, 2019

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (ACTUAL): March 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Physiotherapy; Arthropathy; Manual therapy; Hemophilia; Joint health
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Blood Coagulation Disorders; Hemophilia A; Joint Diseases
• Other Study ID Numbers: Necmettin Erb. Physiotherapy-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No