Osteoarthritis HipMWMNCT02390336
Mobilization With Movement in Patients With Osteoarthritis of the Hip
A study testing Real mobilization-with-movement (MWM) in people with Osteoarthritis Hip and Joint Disease, run by Natália Maria Oliveira Campelo.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis Hip, Joint Disease, Musculoskeletal Diseases
- What is being tested?
- Real mobilization-with-movement (MWM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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..
- Being tested
- Real mobilization-with-movement (MWM), Sham mobilization-with-movement (MWM)
- Keywords
- Osteoarthritis of the hip, Pain, Range of Motion, Physical Function, Manual Therapy
- Medical subject headings
- Osteoarthritis, Hip, Joint Diseases, Musculoskeletal Diseases, Pathologic Processes, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real mobilization-with-movement (MWM)Other
Also called Group Experimental: mobilization-with-movement (MWM)
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.
Sham mobilization-with-movement (MWM)Other
Also called Group Sham: mobilization-with-movement (MWM)
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.
| Study group | Role | What they receive |
|---|---|---|
| Real mobilization-with-movement (MWM) | Experimental | 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. Receives: Other: Real mobilization-with-movement (MWM) |
| Sham mobilization-with-movement (MWM) | Sham comparator | 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. Receives: Other: Sham mobilization-with-movement (MWM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: participants will be assessed before and after intervention (interval: 15-20 minutes)
Secondary outcomes (5)
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.
Measured: participants will be assessed before and after intervention (interval: 15-20 minutes)
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.
Measured: participants will be assessed before and after intervention (interval: 15-20 minutes)
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.
Measured: participants will be assessed before and after intervention (interval: 15-20 minutes)
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.
Measured: participants will be assessed before and after intervention (interval: 15-20 minutes)
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).
Measured: participants will be assessed before and after intervention (interval: 15-20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis HipStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natália Maria Oliveira Campelo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália Campelo, PhD, Study director, Polytechnic Institute of Porto (Portugal)Francisco Neto, MSc, Study director, Polytechnic Institute of Porto (Portugal)Carlos Beselga, MSc, Principal investigator, Polytechnic Institute of Porto (Portugal)Francisco A Sendín, PhD, Study director, University of Salamanca (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390336
- Sponsor's protocol ID
- NC-002
- Acronym
- MWM
- Status last verified
- May 2015
- First submitted
- 3 Mar 2015
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16959529Hoeksma 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.
PubMed 15695307Botha-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.
PubMed 16740397French 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.
PubMed 23084955Hando 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.
PubMed 24179327Beselga 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.
PubMed 26559319
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02390336
- Acronym / sponsor ID
- MWM / NC-002
- Keywords
- Osteoarthritis of the hip, Pain, Range of Motion, Physical Function, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Natália Maria Oliveira CampeloUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real mobilization-with-movement (MWM) | Experimental | Other: Real mobilization-with-movement (MWM)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. |
| Sham mobilization-with-movement (MWM) | Sham comparator | Other: Sham mobilization-with-movement (MWM)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Real mobilization-with-movement (MWM)Also: Group Experimental: mobilization-with-movement (MWM)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. | Other | Real mobilization-with-movement (MWM) |
| Sham mobilization-with-movement (MWM)Also: Group Sham: mobilization-with-movement (MWM)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. | Other | Sham mobilization-with-movement (MWM) |
Primary outcome
Changes in the intensity of hip pain before and after the treatment
Time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)
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).
5 secondary outcomes
Changes in the range of motion for the hip flexion before and after the treatment
Time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)
Changes in the range of motion for the medial hip rotation before and after the treatment
Time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)
Changes in the performing time of the physical function test timed up and go before and after the treatment
Time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)
Changes in the repetitions of the physical function test 30 seg sit to stand before and after the treatment
Time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)
Changes in the performing time of the physical function test 40 m. self placed walk before and after the treatment
Time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 16959529Vicenzino 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.
- Background: PubMed 15695307Hoeksma 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.
- Background: PubMed 16740397Botha-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.
- Background: PubMed 23084955French 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.
- Background: PubMed 24179327Hando 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.
- Derived from this study: PubMed 26559319Beselga 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.
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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.
Natália Campelo, PhD study director
Polytechnic Institute of Porto (Portugal)
Francisco Neto, MSc study director
Polytechnic Institute of Porto (Portugal)
Carlos Beselga, MSc principal investigator
Polytechnic Institute of Porto (Portugal)
Questions about this trial
What is this clinical trial studying?
A study testing Real mobilization-with-movement (MWM) in people with Osteoarthritis Hip and Joint Disease, run by Natália Maria Oliveira Campelo.
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 5 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the intensity of hip pain before and after the treatment (time frame: participants will be assessed before and after intervention (interval: 15-20 minutes)). 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 NCT02390336, which also lists 6 linked publications.
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 28 May 2015.