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Completed

NCT Number: 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elena Estebanez de Miguel

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grade I-II SZ mobilization

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

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

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.

Primary outcomes

  1. Pain on the VAS scale

    Time frame: pre-intervention and post-intervention (baseline and 5 days)

  2. Pressure Pain Threshold (PPT)

    Time frame: pre-intervention and post-intervention (baseline and 5 days)

  3. 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 outcomes

  1. Physical Function on Timed Up & Go test (TUG)

    Time frame: pre-intervention and post-intervention (baseline and 5 days)

  2. Physical Function on the 20-Meter Walking Test

    Time frame: pre-intervention and post-intervention (baseline and 5 days)

  3. 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)

  4. 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

  5. Rectus femoris flexibility assessment: Ely´s test

    Time frame: pre-intervention and post-intervention (baseline and 5 days)

  6. Hamstring flexibility assessment: Active Knee test

    Time frame: pre-intervention and post-intervention after each session (baseline and 5 days)

  7. Iliotibial band tightness assessment: modified Ober´s test

    Time frame: pre-intervention and post-intervention (baseline and 5 days)

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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