Elena Estebanez de Miguel
Zaragoza, 50009, Spain
NCT Number: NCT02498314
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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Notify Me50 year and older
All sexes
Interventional
Not applicable
Zaragoza, 50009, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Time frame: pre-intervention and the next day of the last treatment session (baseline and 6 days)
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Time frame: pre-intervention and the next day of the last treatment session (baseline and 6 days)
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
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Time frame: pre-intervention and post-intervention after each session (baseline and 5 days)
Time frame: pre-intervention and post-intervention (baseline and 5 days)
Universidad de Zaragoza
Other
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