Clinical Trial: Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

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 experien

Detailed Summary:
Sponsor: Universidad de Zaragoza

Current Primary Outcome:

  • Pain on the VAS scale [ Time Frame: pre-intervention and post-intervention (baseline and 5 days) ]
  • Pressure Pain Threshold (PPT) [ Time Frame: 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) ]


Original Primary Outcome:

  • Pain on the VAS scale [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
  • Pressure Pain Threshold (PPT) [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
  • Pain on the pain subscale of WOMAC index (WOMAC-P) [ Time Frame: pre-intervention of each session and the next day of the treatment session (up to 6 days) ]


Current Secondary Outcome:

  • Physical Function on Timed Up & Go test (TUG) [ Time Frame: 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) ]
  • 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) ]
  • 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
  • Rectus femoris flexibility assessment: Ely´s test [ Time Frame: 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) ]
  • Iliotibial band tightness assessment: modified Ober´s test [ Time Frame: pre-intervention and post-intervention (baseline and 5 days) ]


Original Secondary Outcome:

  • Physical Function on Timed Up & Go test (TUG) [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
  • Physical Function on the 20-Meter Walking Test [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
  • Physical Function on The physical function subscale of WOMAC index (WOMAC-PF) [ Time Frame: pre-intervention of each session and the next day of the treatment session (up to 6 days) ]
  • Hip range of motion with digital inclinometer [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
    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 [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
  • Hamstring flexibility assessment: Active Knee test [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]
  • Iliotibial band tightness assessment: modified Ober´s test [ Time Frame: pre-intervention and post-intervention after each session (up to 5 days) ]


Information By: Universidad de Zaragoza

Dates:
Date Received: July 8, 2015
Date Started: April 2015
Date Completion: October 2015
Last Updated: July 20, 2015
Last Verified: July 2015