NCT02390336

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

March 3, 2015

Last Update Submit

May 27, 2015

Conditions

Keywords

Osteoarthritis of the hipPainRange of MotionPhysical FunctionManual Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    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

    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

    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

    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

    participants will be assessed before and after intervention (interval: 15-20 minutes)

Study Arms (2)

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.

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.

Other: Sham mobilization-with-movement (MWM)

Interventions

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.

Also known as: Group Experimental: mobilization-with-movement (MWM)
Real 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.

Also known as: Group Sham: mobilization-with-movement (MWM)
Sham mobilization-with-movement (MWM)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 16959529BACKGROUND
  • 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.

    PMID: 15695307BACKGROUND
  • 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.

    PMID: 16740397BACKGROUND
  • 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.

    PMID: 23084955BACKGROUND
  • 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.

    PMID: 24179327BACKGROUND
  • 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.

MeSH Terms

Conditions

Osteoarthritis, HipJoint DiseasesMusculoskeletal DiseasesPathologic ProcessesPain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisRheumatic DiseasesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Natália Campelo, PhD

    Polytechnic Institute of Porto (Portugal)

    STUDY DIRECTOR
  • Francisco Neto, MSc

    Polytechnic Institute of Porto (Portugal)

    STUDY DIRECTOR
  • Carlos Beselga, MSc

    Polytechnic Institute of Porto (Portugal)

    PRINCIPAL INVESTIGATOR
  • Francisco A Sendín, PhD

    University of Salamanca (Spain)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05