Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

Hip Osteoarthritis Clinical Trial

Official title:

Clinical Effects of Translatoric Grades of Movement in Hip Osteoarthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498314
• Other study ID #: PI11/00061
• Secondary ID: PUZ/1
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: June 29, 2017
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2017
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Elena Estebanez de Miguel	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on the VAS scale		pre-intervention and post-intervention (baseline and 5 days)
Primary	Pressure Pain Threshold (PPT)		pre-intervention and post-intervention (baseline and 5 days)
Primary	Pain on the pain subscale of WOMAC index (WOMAC-P)		pre-intervention and the next day of the last treatment session (baseline and 6 days)
Secondary	Physical Function on Timed Up & Go test (TUG)		pre-intervention and post-intervention (baseline and 5 days)
Secondary	Physical Function on the 20-Meter Walking Test		pre-intervention and post-intervention (baseline and 5 days)
Secondary	Physical Function on The physical function subscale of WOMAC index (WOMAC-PF)		pre-intervention and the next day of the last treatment session (baseline and 6 days)
Secondary	Hip range of motion with digital inclinometer	Passive hip range of motion in the three planes is measured before and after each treatment sessions with a digital inclinometer	pre-intervention and post-intervention (baseline and 5 days)
Secondary	Rectus femoris flexibility assessment: Ely´s test		pre-intervention and post-intervention (baseline and 5 days)
Secondary	Hamstring flexibility assessment: Active Knee test		pre-intervention and post-intervention after each session (baseline and 5 days)
Secondary	Iliotibial band tightness assessment: modified Ober´s test		pre-intervention and post-intervention (baseline and 5 days)