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Mobilization With Movement in Patients With Osteoarthritis of the Hip (MWM)

Primary Purpose

Osteoarthritis Hip, Joint Disease, Musculoskeletal Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Real mobilization-with-movement (MWM)
Sham mobilization-with-movement (MWM)
Sponsored by
Natália Maria Oliveira Campelo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Hip focused on measuring Osteoarthritis of the hip, Pain, Range of Motion, Physical Function, Manual Therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

clinical criteria for the diagnosis of osteoarthritis of the hip (sensitivity 86% and specificity 75%) are:

  • Medial hip rotation ≥15º, pain during medial rotation of the hip, morning fatigue in hip> 60 minutes and older than 50 years or
  • Medial hip rotation <15, hip flexion ≤ 115

Exclusion Criteria:

  • Previous surgery or hip replacement or knee joint
  • Another surgery in the lower extremities performed within 6 months, rheumatoid arthritis
  • Uncontrolled hypertension or risk (moderate - high) of cardiac complications during exercise
  • Disability unrelated to the hip or knee to prevent the safe participation during exercise, appliance of manual therapy or during march: vision problems affecting mobility, body weight equal to or greater than 155 kg, primary neurogenic disorder or significantly limitation of the lumbar level,advanced osteoporosis with manual therapy or other treatment technique that may interfere with the study
  • With inability to understand the instructions and complete the study assessments

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Real mobilization-with-movement (MWM)

    Sham mobilization-with-movement (MWM)

    Arm Description

    In each volunteer of this group, the blind assessor will perform the pre-intervention measurements of intensity of pain, range of motion and physical function tests. Next, the therapist will performed the real mobilization-with-movement. Then, all measurements, before described, will be repeated, by the assessor.

    In each volunteer of this group, the blind assessor will perform the pre-intervention measurements of intensity of pain, range of motion and physical function tests. Next, the therapist will performed the sham mobilization-with-movement. Then, all measurements, before described, will be repeated, by the assessor.

    Outcomes

    Primary Outcome Measures

    Changes in the intensity of hip pain before and after the treatment
    Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain).

    Secondary Outcome Measures

    Changes in the range of motion for the hip flexion before and after the treatment
    Assess ROM of the hip joint was used a universal goniometer BIOMET® (CAT.No.567330), it was considered a valid instrument to measure hip flexion.
    Changes in the range of motion for the medial hip rotation before and after the treatment
    Assess ROM of the hip joint was used a universal goniometer BIOMET® (CAT.No.567330), it was considered a valid instrument to measure medial hip rotation.
    Changes in the performing time of the physical function test timed up and go before and after the treatment
    The Timed "Up and Go" Test (TUG) is presented as a test that simulates some functional maneuvers of daily life, like, getting up, walking, running laps and siting down.
    Changes in the repetitions of the physical function test 30 seg sit to stand before and after the treatment
    The 30 sec Sit to Stand test or 30 sec Chair Stand Test (CST) is the functional evaluation of the strength of the lower limbs.Is to repeat the activity of sit and lift a maximum number of times during 30 seconds.
    Changes in the performing time of the physical function test 40 m. self placed walk before and after the treatment
    The test 40m Self Placed Walk (SPWT) consists is the functional assessment of physical ability of an individual coursing short distances (40 meters).

    Full Information

    First Posted
    March 3, 2015
    Last Updated
    May 27, 2015
    Sponsor
    Natália Maria Oliveira Campelo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02390336
    Brief Title
    Mobilization With Movement in Patients With Osteoarthritis of the Hip
    Acronym
    MWM
    Official Title
    The Immediate Effects of Mulligan Mobilization With Movement Technique in Pain, Range of Motion and Physical Function in Patients With Osteoarthritis of the Hip
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Natália Maria Oliveira Campelo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The concept of mobilization with movement, also referred to as a Mulligan mobilization, has not been studied in patients with hip osteoarthritis, subsisting questions about the possible effects in this population. The aim of this randomized controlled study is to compare the immediate effects of Mulligan mobilization with movement technique of pain, range of motion and physical function in patients with osteoarthritis of the hip.
    Detailed Description
    Mulligan original theory for the efficacy of a Mobilization With Movement (MWM) is based on the concept associated with a "positional joint failure," which occurs due to injury and may lead to a change in the joint alignment and hence its biomechanical resulting in symptoms such as pain, joint stiffness or weakness. To perform the MWM technique it is required to implement many criteria. During execution is applied an maintained accessory glide in order to correct the positional fault, while a physiological movement or action that usually caused the pain is performed actively or passively. A key component for the MWM is that pain should always be reduced and / or eliminated during application. All study participants will be submitted to an initial assessment protocol to determine the intensity of pain, the range of motion (ROM) in flexion and internal rotation of the hip and the collection of physical function parameters. After that, the intervention will be performed for each group, and then the re-evaluation will be carried out (final evaluation), pain intensity, ROM and physical function tests..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis Hip, Joint Disease, Musculoskeletal Diseases, Pathologic Processes
    Keywords
    Osteoarthritis of the hip, Pain, Range of Motion, Physical Function, Manual Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Real mobilization-with-movement (MWM)
    Arm Type
    Experimental
    Arm Description
    In each volunteer of this group, the blind assessor will perform the pre-intervention measurements of intensity of pain, range of motion and physical function tests. Next, the therapist will performed the real mobilization-with-movement. Then, all measurements, before described, will be repeated, by the assessor.
    Arm Title
    Sham mobilization-with-movement (MWM)
    Arm Type
    Sham Comparator
    Arm Description
    In each volunteer of this group, the blind assessor will perform the pre-intervention measurements of intensity of pain, range of motion and physical function tests. Next, the therapist will performed the sham mobilization-with-movement. Then, all measurements, before described, will be repeated, by the assessor.
    Intervention Type
    Other
    Intervention Name(s)
    Real mobilization-with-movement (MWM)
    Other Intervention Name(s)
    Group Experimental: mobilization-with-movement (MWM)
    Intervention Description
    For the MWM group, the investigator applied two techniques of mobilization with movement: one for flexion and one for medial rotation of the hip. With the hip in flexion, a stabilizing belt was placed on the medial side of the participant's thigh closest to the joint interline. The belt was placed around the pelvic region of the physical therapist, keeping a perpendicular direction to the participant's thigh. Maintaining a side slip, it was carried out a passive movement of 1) hip flexion (3x10) and 2) medial hip rotation (3x10) by the physiotherapist throughout painless amplitude.
    Intervention Type
    Other
    Intervention Name(s)
    Sham mobilization-with-movement (MWM)
    Other Intervention Name(s)
    Group Sham: mobilization-with-movement (MWM)
    Intervention Description
    In the sham group, the investigators conducted a technical simulation. The positioning of the patient and the physical therapist was the same, however, no accessory mobilization was performed with the help of the belt and did not performed repeated movements of passive flexion or medial rotation.
    Primary Outcome Measure Information:
    Title
    Changes in the intensity of hip pain before and after the treatment
    Description
    Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain).
    Time Frame
    participants will be assessed before and after intervention (interval: 15-20 minutes)
    Secondary Outcome Measure Information:
    Title
    Changes in the range of motion for the hip flexion before and after the treatment
    Description
    Assess ROM of the hip joint was used a universal goniometer BIOMET® (CAT.No.567330), it was considered a valid instrument to measure hip flexion.
    Time Frame
    participants will be assessed before and after intervention (interval: 15-20 minutes)
    Title
    Changes in the range of motion for the medial hip rotation before and after the treatment
    Description
    Assess ROM of the hip joint was used a universal goniometer BIOMET® (CAT.No.567330), it was considered a valid instrument to measure medial hip rotation.
    Time Frame
    participants will be assessed before and after intervention (interval: 15-20 minutes)
    Title
    Changes in the performing time of the physical function test timed up and go before and after the treatment
    Description
    The Timed "Up and Go" Test (TUG) is presented as a test that simulates some functional maneuvers of daily life, like, getting up, walking, running laps and siting down.
    Time Frame
    participants will be assessed before and after intervention (interval: 15-20 minutes)
    Title
    Changes in the repetitions of the physical function test 30 seg sit to stand before and after the treatment
    Description
    The 30 sec Sit to Stand test or 30 sec Chair Stand Test (CST) is the functional evaluation of the strength of the lower limbs.Is to repeat the activity of sit and lift a maximum number of times during 30 seconds.
    Time Frame
    participants will be assessed before and after intervention (interval: 15-20 minutes)
    Title
    Changes in the performing time of the physical function test 40 m. self placed walk before and after the treatment
    Description
    The test 40m Self Placed Walk (SPWT) consists is the functional assessment of physical ability of an individual coursing short distances (40 meters).
    Time Frame
    participants will be assessed before and after intervention (interval: 15-20 minutes)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical criteria for the diagnosis of osteoarthritis of the hip (sensitivity 86% and specificity 75%) are: Medial hip rotation ≥15º, pain during medial rotation of the hip, morning fatigue in hip> 60 minutes and older than 50 years or Medial hip rotation <15, hip flexion ≤ 115 Exclusion Criteria: Previous surgery or hip replacement or knee joint Another surgery in the lower extremities performed within 6 months, rheumatoid arthritis Uncontrolled hypertension or risk (moderate - high) of cardiac complications during exercise Disability unrelated to the hip or knee to prevent the safe participation during exercise, appliance of manual therapy or during march: vision problems affecting mobility, body weight equal to or greater than 155 kg, primary neurogenic disorder or significantly limitation of the lumbar level,advanced osteoporosis with manual therapy or other treatment technique that may interfere with the study With inability to understand the instructions and complete the study assessments
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Natália Campelo, PhD
    Organizational Affiliation
    Polytechnic Institute of Porto (Portugal)
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Francisco Neto, MSc
    Organizational Affiliation
    Polytechnic Institute of Porto (Portugal)
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Carlos Beselga, MSc
    Organizational Affiliation
    Polytechnic Institute of Porto (Portugal)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Francisco A Sendín, PhD
    Organizational Affiliation
    University of Salamanca (Spain)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16959529
    Citation
    Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. doi: 10.1016/j.math.2006.07.012. Epub 2006 Sep 7.
    Results Reference
    background
    PubMed Identifier
    15695307
    Citation
    Hoeksma HL, Dekker J, Ronday HK, Breedveld FC, Van den Ende CH. Manual therapy in osteoarthritis of the hip: outcome in subgroups of patients. Rheumatology (Oxford). 2005 Apr;44(4):461-4. doi: 10.1093/rheumatology/keh482. Epub 2005 Feb 3.
    Results Reference
    background
    PubMed Identifier
    16740397
    Citation
    Botha-Scheepers S, Riyazi N, Kroon HM, Scharloo M, Houwing-Duistermaat JJ, Slagboom E, Rosendaal FR, Breedveld FC, Kloppenburg M. Activity limitations in the lower extremities in patients with osteoarthritis: the modifying effects of illness perceptions and mental health. Osteoarthritis Cartilage. 2006 Nov;14(11):1104-10. doi: 10.1016/j.joca.2006.04.011. Epub 2006 Jun 5.
    Results Reference
    background
    PubMed Identifier
    23084955
    Citation
    French HP, Cusack T, Brennan A, Caffrey A, Conroy R, Cuddy V, FitzGerald OM, Fitzpatrick M, Gilsenan C, Kane D, O'Connell PG, White B, McCarthy GM. Exercise and manual physiotherapy arthritis research trial (EMPART) for osteoarthritis of the hip: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2013 Feb;94(2):302-14. doi: 10.1016/j.apmr.2012.09.030. Epub 2012 Oct 16. Erratum In: Arch Phys Med Rehabil. 2013 Mar;94(3):600. Fitzpatrick, Martina [added].
    Results Reference
    background
    PubMed Identifier
    24179327
    Citation
    Hando BR, Gill NW, Walker MJ, Garber M. Short- and long-term clinical outcomes following a standardized protocol of orthopedic manual physical therapy and exercise in individuals with osteoarthritis of the hip: a case series. J Man Manip Ther. 2012 Nov;20(4):192-200. doi: 10.1179/2042618612Y.0000000013.
    Results Reference
    background
    PubMed Identifier
    26559319
    Citation
    Beselga C, Neto F, Alburquerque-Sendin F, Hall T, Oliveira-Campelo N. Immediate effects of hip mobilization with movement in patients with hip osteoarthritis: A randomised controlled trial. Man Ther. 2016 Apr;22:80-5. doi: 10.1016/j.math.2015.10.007. Epub 2015 Oct 31.
    Results Reference
    derived

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    Mobilization With Movement in Patients With Osteoarthritis of the Hip

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