Clinical trial NCT02498314: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Manual therapy
Hip osteoarthritis
Mobilization
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain on the VAS scale
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
measure: Pressure Pain Threshold (PPT)
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
measure: Pain on the pain subscale of WOMAC index (WOMAC-P)
timeFrame: pre-intervention and the next day of the last treatment session (baseline and 6 days)
Secondary outcomes:
measure: Physical Function on Timed Up & Go test (TUG)
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
measure: Physical Function on the 20-Meter Walking Test
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
measure: Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)
timeFrame: pre-intervention and the next day of the last treatment session (baseline and 6 days)
measure: Hip range of motion with digital inclinometer
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
measure: Rectus femoris flexibility assessment: Ely´s test
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
measure: Hamstring flexibility assessment: Active Knee test
timeFrame: pre-intervention and post-intervention after each session (baseline and 5 days)
measure: Iliotibial band tightness assessment: modified Ober´s test
timeFrame: pre-intervention and post-intervention (baseline and 5 days)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Elena Estebanez de Miguel
Study officials:
affiliation: Unidad de Investigación en Fisioterapia. Zaragoza, Zaragoza, Spain
name: Elena Estebanez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.