- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498314
Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zaragoza, Spain, 50009
- Elena Estebanez de Miguel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Grade I-II SZ mobilization
Grade I-IISZ hip traction in resting position
|
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.
|
Experimental: Grade II TZ mobilization
Grade IITZ hip traction in resting position
|
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.
|
Experimental: Grade III mobilization
Grade III hip traction in resting position
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain on the VAS scale
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
pre-intervention and post-intervention (baseline and 5 days)
|
Pressure Pain Threshold (PPT)
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
pre-intervention and post-intervention (baseline and 5 days)
|
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)
|
pre-intervention and the next day of the last treatment session (baseline and 6 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function on Timed Up & Go test (TUG)
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
pre-intervention and post-intervention (baseline and 5 days)
|
|
Physical Function on the 20-Meter Walking Test
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
pre-intervention and post-intervention (baseline and 5 days)
|
|
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)
|
pre-intervention and the next day of the last treatment session (baseline and 6 days)
|
|
Hip range of motion with digital inclinometer
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
Passive hip range of motion in the three planes is measured before and after each treatment sessions with a digital inclinometer
|
pre-intervention and post-intervention (baseline and 5 days)
|
Rectus femoris flexibility assessment: Ely´s test
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
pre-intervention and post-intervention (baseline and 5 days)
|
|
Hamstring flexibility assessment: Active Knee test
Time Frame: pre-intervention and post-intervention after each session (baseline and 5 days)
|
pre-intervention and post-intervention after each session (baseline and 5 days)
|
|
Iliotibial band tightness assessment: modified Ober´s test
Time Frame: pre-intervention and post-intervention (baseline and 5 days)
|
pre-intervention and post-intervention (baseline and 5 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elena Estebanez, PhD, Unidad de Investigación en Fisioterapia. Zaragoza, Zaragoza, Spain
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI11/00061
- PUZ/1 (Other Identifier: Universidad de Zaragoza)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Osteoarthritis
-
Istituto Ortopedico RizzoliRecruiting
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
CHU de ReimsCompleted
-
Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
-
Daiichi Sankyo, Inc.TerminatedSymptomatic Hip OsteoarthritisFrance
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
-
Lawson Health Research InstituteCompletedHip Osteoarthritis | Hip ArthroplastyCanada
Clinical Trials on Grade I-II SZ mobilization
-
Messiah CollegeUnknownAnterior Knee Pain Syndrome
-
University of Lausanne HospitalsCompletedOsteoarthritis, KneeSwitzerland
-
Creighton UniversityNebraska Foundation for Physical TherapyCompletedAnkle SprainUnited States
-
Creighton UniversityCompletedShoulder Range of Motion in Healthy IndividualsUnited States
-
Luis Jara-Palomares, MDMerck Sharp & Dohme LLC; Sociedad Española de Neumología y Cirugía TorácicaCompletedPulmonary Embolism | Dyspnea | Symptoms and Signs | CTEPHSpain
-
Jordi Gol i Gurina FoundationUnknown
-
Creighton UniversityCompletedChondromalacia Patellae | Patellofemoral Pain Syndrome | Anterior Knee Pain SyndromeUnited States
-
SVS Institute of Dental SciencesCompleted
-
Ibrahim Talal ElshamyRecruitingChronic Rhinosinusitis With Nasal Polyps | Endoscopic Frontal Sinus Surgery | Draf III | Draf I or IIaEgypt
-
University of California, DavisMars, Inc.Completed