Patients With HemophiliaELBOWNCT02198040

Physiotherapy in the Haemophilic Arthropathy of the Elbow.

A study testing Manual Therapy and Educational group in people with Patients With Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to assess the effectiveness of two treatments of Physiotherapy: one with joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation (PNF), and the other with education sessions and home exercises, for the improvement of the ROM, biceps strength, perimeter of arm… Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Patients With Hemophilia
What is being tested?: Manual Therapy and Educational group
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteSpain
Study dates: Jan 2012to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients over 18 years
Patients diagnosed with hemophilia A or B
Patients with hemophilic arthropathy in one or both elbows

Who cannot join

Patients with another medical diagnosis (eg, Von Willebrand's disease)
Patients with presence of antibodies to FVIII or FIX (inhibitors)
Patients who had a haemarthrosis of elbow during the study

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad de Murcia
Murcia, 30100

Other trials in Spain

About this study

Official title: Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy

Read the detailed description

The intervention was carried out during twelve weeks, performing evaluations before and after treatment, and six months of finalizing this. The treatment of MT group consisted of two sessions per week, one hour each, and the treatment of group E consisted in a session for 90 minutes every two weeks, with daily home exercises. The control group (group C) did not receive any intervention.

Conditions: Patients With Hemophilia
Being tested: Manual Therapy, Educational group
Keywords: Elbow, Joint disease, Hemophilia, Physiotherapy modalities
Medical subject headings: Joint Diseases, Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual TherapyOther
- 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
- 15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
- 15 minutes. Passive muscle stretching (within the limits of mobility).
- 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder.
- 10 minutes. Local cryotherapy with ice bag and protection between it and the skin
Educational groupOther
- Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.

Study groups in NCT02198040
Study group	Role	What they receive
Manual Therapy group	Experimental	The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation Receives: Other: Manual Therapy
Educational group	Experimental	The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow. Receives: Other: Educational group
Control group	No intervention	The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Range of Motion of Elbow
Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in the Circumference of Arm
Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in Biceps Strength
Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Changes in the Pain Perception of Elbow
Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).
Measured: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Assessment of Radiological Joint Deterioration
Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)
Measured: Screening visit (pretreatment assessment)

Secondary outcomes (2)

Characteristics of the Patients
Age of patients included in teh study (years)
Measured: Screening visit (pretreatment assessment)
Frequency of Elbow Hemarthrosis
Number of elbow hemarthrosis in the month prior to study
Measured: Screening visit (pretreatment assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jun 2014

First posted23 Jul 2014 (estimated)
Study startJan 2012
Primary completionOct 2012
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patients With HemophiliaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02198040
Sponsor's protocol ID: ELBOW
Other IDs: ELBOW
Acronym: ELBOW
Status last verified: Dec 2016
First submitted: 21 Jul 2014
Last updated: 1 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cuesta-Barriuso R, Gomez-Conesa A, Lopez-Pina JA. Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study. Orphanet J Rare Dis. 2018 Sep 3;13(1):151. doi: 10.1186/s13023-018-0884-5.
PubMed 30176883

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Patients With Hemophilia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiotherapy in the Treatment of Elbow Hemophilic Arthropathy: Manual Therapy vs Educational Physiotherapy. A Pilot Sudy
ClinicalTrials.gov ID: NCT02198040
Acronym / sponsor ID: ELBOW / ELBOW
Conditions: Patients With Hemophilia
Keywords: Elbow, Joint disease, Hemophilia, Physiotherapy modalities
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Universidad Católica San Antonio de MurciaUniversity, hospital or other
Study start: Jan 2012
Primary completion: Oct 2012 (actual)
Study completion: Jun 2014 (actual)
First posted: 23 Jul 2014 (estimated)
Results: Posted 23 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Manual Therapy group	Experimental	Other: Manual TherapyThe treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation
Educational group	Experimental	Other: Educational groupThe treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.
Control group	No intervention	–The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients over 18 years
Patients diagnosed with hemophilia A or B
Patients with hemophilic arthropathy in one or both elbows

Key exclusion criteria (3 listed)

Patients with another medical diagnosis (eg, Von Willebrand's disease)
Patients with presence of antibodies to FVIII or FIX (inhibitors)
Patients who had a haemarthrosis of elbow during the study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Manual Therapy* 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w. * 15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow. * 15 minutes. Passive muscle stretching (within the limits of mobility). * 15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder. * 10 minutes. Local cryotherapy with ice bag and protection between it and the skin	Other	Manual Therapy group
Educational group* Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits. * Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique.	Other	Educational group

Primary outcome

Changes in Range of Motion of Elbow
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.
Changes in the Circumference of Arm
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.
Changes in Biceps Strength
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).
Changes in the Pain Perception of Elbow
Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)
Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).
Assessment of Radiological Joint Deterioration
Time frame: Screening visit (pretreatment assessment)
Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)

2 secondary outcomes

Characteristics of the Patients
Time frame: Screening visit (pretreatment assessment)
Frequency of Elbow Hemarthrosis
Time frame: Screening visit (pretreatment assessment)

Results and safety

Results posted to the registry on 23 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Manual Therapy Group	9	9
Educational Gruop	9	8
Control Group	9	8

Primary outcome: Changes in Range of Motion of Elbow

Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment). Mean (Standard Deviation). Unit: degrees

Measure	Educational Gruop n = 9	Manual Therapy Group n = 9	Control Group n = 9
Pretreatment assessment	138.31 (16.103)	136.13 (14.818)	138.00 (19.958)
Postreatment assessment	135.56 (16.66)	140.31 (11.24)	138.43 (18.47)
Follow up assessment	139.19 (16.64)	140.31 (14.44)	138.07 (17.39)

Population analysed: It has made an analysis by intention to treat with the 27 patients included in the study.

Primary outcome: Changes in the Circumference of Arm

Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment). Mean (Standard Deviation). Unit: cm

Measure	Educational Gruop n = 9	Manual Therapy Group n = 9	Control Group n = 9
Pretreatment assessment	31.125 (3.144)	31.331 (3.474)	32.007 (3.837)
Postreatment assessment	31.23 (3.22)	31.72 (3.20)	31.85 (3.56)
Follow up assessment	31.02 (3.13)	30.96 (2.70)	31.68 (4.11)

Population analysed: It has made an analysis by intention to treat with the 27 patients included in the study

Primary outcome: Changes in Biceps Strength

Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment). Mean (Standard Deviation). Unit: points

Measure	Educational Gruop n = 9	Manual Therapy Group n = 9	Control Group n = 9
Pretreatment assessment	0.000 (0.000)	0.094 (0.272)	0.143 (0.363)
Postreatment assessment	0.03 (0.12)	0.00 (0.00)	0.07 (0.18)
Follow up assessment	0.06 (0.17)	0.00 (0.00)	0.07 (0.18)

Population analysed: It has made an analysis by intention to treat with the 27 patients included in the study

Primary outcome: Changes in the Pain Perception of Elbow

Time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment). Mean (Standard Deviation). Unit: points

Measure	Educational Gruop n = 8	Manual Therapy Group n = 8	Control Group n = 7
Pretreatment assessment	0.156 (0.301)	0.719 (0.752)	0.143 (0.305)
Postreatment assessment	0.09 (0.20)	0.34 (0.43)	0.07 (0.67)
Follow up assessment	0.18 (0.35)	0.12 (0.28)	0.10 (0.28)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Educational Gruop	0 of 9 (0%)	0 of 9 (0%)	Not reported
Manual Therapy Group	0 of 9 (0%)	0 of 9 (0%)	Not reported
Control Group	0 of 9 (0%)	0 of 9 (0%)	Not reported

Limitations and caveats (from the sponsor): A limitation of our study is the low sample size (n = 27), although 96% of paients who met the inclusion criteria participated Due to the randomization of subjects there was no division proportionate according to the severity of haemophilia

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30176883Cuesta-Barriuso R, Gomez-Conesa A, Lopez-Pina JA. Manual and educational therapy in the treatment of hemophilic arthropathy of the elbow: a randomized pilot study. Orphanet J Rare Dis. 2018 Sep 3;13(1):151. doi: 10.1186/s13023-018-0884-5.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

RUBEN CUESTA-BARRIUSO, PhD principal investigator

Universidad Católica San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Manual Therapy and Educational group in people with Patients With Hemophilia, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Range of Motion of Elbow (time frame: Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02198040, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.