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Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

Primary Purpose

Hip Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Grade I-II SZ mobilization
Grade II TZ mobilization
Grade III mobilization
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Manual therapy, Hip osteoarthritis, Mobilization

Eligibility Criteria

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

Inclusion Criteria:

  • unilateral primary hip OA according to the clinical criteria of the American College of Reumathology,
  • a grade III Kellgren & Lawrence (K-L) classification in their most recent hip X-rays,
  • mild to moderate pain from hip OA categorized using the WOMAC pain subscale (2 to 8 as mild pain; greater than 8 to 12 as moderate pain),
  • the ability to walk at least 20 meters, with or without an aid.

Exclusion Criteria:

  • neurological, vascular or other lower extremity musculoskeletal conditions that affected sensation, gait or functional performance,
  • contraindications for manual therapy
  • insufficient understanding of the Spanish language

Sites / Locations

  • Elena Estebanez de Miguel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Grade I-II SZ mobilization

Grade II TZ mobilization

Grade III mobilization

Arm Description

Grade I-IISZ hip traction in resting position

Grade IITZ hip traction in resting position

Grade III hip traction in resting position

Outcomes

Primary Outcome Measures

Pain on the VAS scale
Pressure Pain Threshold (PPT)
Pain on the pain subscale of WOMAC index (WOMAC-P)

Secondary Outcome Measures

Physical Function on Timed Up & Go test (TUG)
Physical Function on the 20-Meter Walking Test
Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)
Hip range of motion with digital inclinometer
Passive hip range of motion in the three planes is measured before and after each treatment sessions with a digital inclinometer
Rectus femoris flexibility assessment: Ely´s test
Hamstring flexibility assessment: Active Knee test
Iliotibial band tightness assessment: modified Ober´s test

Full Information

First Posted
July 8, 2015
Last Updated
June 29, 2017
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT02498314
Brief Title
Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients
Official Title
Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

5. Study Description

Brief Summary
In orthopaedic manual therapy translatoric grades of movement are used to determine the intensity of force applied during the mobilization. Different clinical effects are described for each translatoric grade of movement but there are not published studies evaluating these clinical effects. The objective of this trial is to determine if force magnitude during hip traction in resting position affects immediate and short-term outcomes (pain, physical function, hip muscle length and hip range of motion) in patients with hip osteoarthritis. For this purpose, investigators conduct a randomized clinical trial, double-blind (patient and physical therapist examiner). Participants entering the study were randomized into 1 of 3 treatment groups: grade I- grade IISZ mobilization, grade IITZ mobilization or grade III mobilization. Participants attend three sessions on alternate days (monday, wednesday, friday) and at the same hour. Measurements are taken prior to treatment, immediately after each session treatment. The participants are recruited from physiotherapy groups or referred by general practitioners and orthopedic surgeons. Participants were assigned to 1 of the 3 study groups through concealed allocation (sealed envelopes) and independent blocked randomization, using a random number generator. One physical therapist enroll patients in the study, while an independent research assistant performed the randomization and prepared the sealed envelopes, which are opened after baseline data collection by the physiotherapist performing the treatments. Participants are treated in a private treatment area and have no knowledge of treatments received by other participants. A second experienced orthopaedic manual therapist applies the standardized hip traction mobilization in resting position at either level of force, during 10 minutes. This amount of mobilization is consistent with clinical practice and previous studies in osteoarthritis patients. Two physiotherapists (third and fourth) with 5 years of experience, who were blinded to participant group, performed all measurements.The outcome measures are pain, physical function, hip muscle length and hip passive range of motion. Pain is registered with visual analogic scale (VAS), Pressure Pain Threshold ( PPT) and WOMAC pain subscale. Physical function is registered using Timed Up & Go test (TUG), the 20-Meter Walking Test (20MWT) and the physical function subscale of WOMAC index. The hip muscle length is measured using Ely´s test, Active Knee Extension test and modified Ober´s test. The passive hip range of motion is measured using inclinometer or goniometer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Manual therapy, Hip osteoarthritis, Mobilization

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Grade I-II SZ mobilization
Arm Type
Experimental
Arm Description
Grade I-IISZ hip traction in resting position
Arm Title
Grade II TZ mobilization
Arm Type
Experimental
Arm Description
Grade IITZ hip traction in resting position
Arm Title
Grade III mobilization
Arm Type
Experimental
Arm Description
Grade III hip traction in resting position
Intervention Type
Other
Intervention Name(s)
Grade I-II SZ mobilization
Intervention Description
Hip grade I-IISZ traction in a resting position is applied using gentle repetitive traction movements during 10 minutes. The mean peak force applied is 2,71N (S.D= 0,94), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
Intervention Type
Other
Intervention Name(s)
Grade II TZ mobilization
Intervention Description
Hip grade IITZ traction in a resting position is applied during 10 minutes. The traction force is applied during 45 seconds with 15 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 5.94 N (S.D= 1), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
Intervention Type
Other
Intervention Name(s)
Grade III mobilization
Intervention Description
Hip grade III traction in a resting position is applied during 10 minutes. The traction force is applied during 30 seconds with 30 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 7.04 N (S.D= 0.32), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
Primary Outcome Measure Information:
Title
Pain on the VAS scale
Time Frame
pre-intervention and post-intervention (baseline and 5 days)
Title
Pressure Pain Threshold (PPT)
Time Frame
pre-intervention and post-intervention (baseline and 5 days)
Title
Pain on the pain subscale of WOMAC index (WOMAC-P)
Time Frame
pre-intervention and the next day of the last treatment session (baseline and 6 days)
Secondary Outcome Measure Information:
Title
Physical Function on Timed Up & Go test (TUG)
Time Frame
pre-intervention and post-intervention (baseline and 5 days)
Title
Physical Function on the 20-Meter Walking Test
Time Frame
pre-intervention and post-intervention (baseline and 5 days)
Title
Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)
Time Frame
pre-intervention and the next day of the last treatment session (baseline and 6 days)
Title
Hip range of motion with digital inclinometer
Description
Passive hip range of motion in the three planes is measured before and after each treatment sessions with a digital inclinometer
Time Frame
pre-intervention and post-intervention (baseline and 5 days)
Title
Rectus femoris flexibility assessment: Ely´s test
Time Frame
pre-intervention and post-intervention (baseline and 5 days)
Title
Hamstring flexibility assessment: Active Knee test
Time Frame
pre-intervention and post-intervention after each session (baseline and 5 days)
Title
Iliotibial band tightness assessment: modified Ober´s test
Time Frame
pre-intervention and post-intervention (baseline and 5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral primary hip OA according to the clinical criteria of the American College of Reumathology, a grade III Kellgren & Lawrence (K-L) classification in their most recent hip X-rays, mild to moderate pain from hip OA categorized using the WOMAC pain subscale (2 to 8 as mild pain; greater than 8 to 12 as moderate pain), the ability to walk at least 20 meters, with or without an aid. Exclusion Criteria: neurological, vascular or other lower extremity musculoskeletal conditions that affected sensation, gait or functional performance, contraindications for manual therapy insufficient understanding of the Spanish language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Estebanez, PhD
Organizational Affiliation
Unidad de Investigación en Fisioterapia. Zaragoza, Zaragoza, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elena Estebanez de Miguel
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29864710
Citation
Estebanez-de-Miguel E, Fortun-Agud M, Jimenez-Del-Barrio S, Caudevilla-Polo S, Bueno-Gracia E, Tricas-Moreno JM. Comparison of high, medium and low mobilization forces for increasing range of motion in patients with hip osteoarthritis: A randomized controlled trial. Musculoskelet Sci Pract. 2018 Aug;36:81-86. doi: 10.1016/j.msksp.2018.05.004. Epub 2018 May 29.
Results Reference
derived

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Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

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