NCT02469025

Brief Summary

Lower limb osteoarthritis is a major health problem in the westernized countries. The current gold standard treatment is joint replacement. However clinical guidelines recommend physical therapy as first option for these patients. Manual therapy has reported good reports in function, range of motion and pain in patients with hip osteoarthritis. The main aim of this study is to test the effects of a manual therapy protocol based on manual traction mobilization of the hip joint in an end range position and compare them with the effects achieve with the same protocol based on manual traction mobilization of the hip joint in a resting position. The investigators will use the caudal traction mobilization described by Kaltenborn. The study will test the effects of both treatments in passive range of motion, function and pain after three weeks of treatment, three weeks after finalizing the treatment and six weeks after.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 2, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

May 26, 2015

Last Update Submit

May 1, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Passive Hip Range of Motion after intervention, at 3 weeks post-intervention and at 6 weeks post intervention

    3 weeks, 6 weeks, 9 weeks

Secondary Outcomes (3)

  • Changes from Baseline in Functional Tests (TUG, fast-paced walk test, stair climb test, 30sec. chair stand test), after intervention, at 3 weeks post-intervention and at 6 weeks post intervention

    3 weeks, 6 weeks, 9 weeks

  • Change from Baseline in Pain on the Visual Analog Scale after intervention, at 3 weeks post-intervention and at 6 weeks post intervention

    3 weeks, 6 weeks, 9 weeks

  • Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale after intervention and at 6 weeks post intervention

    3 weeks, 9 weeks

Study Arms (2)

Resting position mobilization group

EXPERIMENTAL

This group receive six manual therapy interventions based on manual traction mobilization in a resting position of the hip joint. In addition the physical therapist teach the patients six exercises to do at home between manual mobilization sessions.

Other: Manual caudal traction mobilization in resting positionOther: Selftreatment

End range position mobilization group

EXPERIMENTAL

This group receive six manual therapy interventions based on manual traction mobilization in an end range position of the hip joint. In addition the physical therapist teach the patients six exercises to do at home between manual mobilization sessions.

Other: Manual caudal traction mobilization in end range positionOther: Selftreatment

Interventions

Resting position mobilization group
End range position mobilization group

Each subject is advice to do some exercises at home

End range position mobilization groupResting position mobilization group

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hip osteoarthritis diagnosis
  • Diminished range of motion
  • Sign the informed consent

You may not qualify if:

  • Contraindications to Manual Therapy.
  • Sensitivity impairments in low back, pelvis, knee or foot regions.
  • Being involved in other physical therapy treatments
  • To change medication use during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Unidad de Investigación en Fisioterapia

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 11, 2015

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

April 1, 2017

Last Updated

May 2, 2017

Record last verified: 2017-05

Locations