Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

NCT ID: NCT02498314

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Grade I-II SZ mobilization

Grade I-IISZ hip traction in resting position

Group Type EXPERIMENTAL

Grade I-II SZ mobilization

Intervention Type OTHER

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.

Grade II TZ mobilization

Grade IITZ hip traction in resting position

Group Type EXPERIMENTAL

Grade II TZ mobilization

Intervention Type OTHER

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.

Grade III mobilization

Grade III hip traction in resting position

Group Type EXPERIMENTAL

Grade III mobilization

Intervention Type OTHER

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.

Interventions

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Grade I-II SZ mobilization

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

Grade II TZ mobilization

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

Grade III mobilization

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Elena Estebanez de Miguel

Unidad de investigación en Fisioterapia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elena Estebanez, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Investigación en Fisioterapia. Zaragoza, Zaragoza, Spain

Locations

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Elena Estebanez de Miguel

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 29864710 (View on PubMed)

Other Identifiers

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PUZ/1

Identifier Type: OTHER

Identifier Source: secondary_id

PI11/00061

Identifier Type: -

Identifier Source: org_study_id

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