Clinical trial NCT02798900: The Effect of Functional Task Training Combined With Therapeutic Ultrasound on Adults With Hip Osteoarthritis
Official title: The Effect of a Functional Task-training Program Combined With Therapeutic Ultrasound on Pain, Strength, Gait Biomechanics and Functionality in Adults With Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Task-specific exercise
Ultrasonic Waves
Biomechanics
Gait
Rehabilitation
Exercise therapy
Lead sponsor: Universidad del Rosario
Sponsor class: OTHER
Collaborators: name: CORPORACION HOSPITALARIA JUAN CIUDAD, MEDERI
First posted: 2016-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis.

Detailed description: Design

The investigators propose a randomized double blind controlled clinical trial. It would include two comparison groups each with 25 participants with medical diagnosis of hip osteoarthritis classified severity II and III and inclusion criteria of the American College of Rheumatology for the classification and reporting of osteoarthritis of the hip.

All qualified participants will attend a pre-training (baseline) data collection session. During the data collection session, each participant will complete the Western Ontario and MacMaster Osteoarthritis Index (WOMAC). All participants will perform visual analog scale and six minutes walk test for assessing pain and functionality, respectively. They will be assessed their hip muscle strength using manual muscle dynamometer. Their biomechanics gait will be assessed through using an infrared motion capture system, force platforms and motion analysis software (120 Hz, BTS Smart DX100, Italy). All participants in both groups will be asked not to alter their regular physical activity or pain medications during the 15-sessions training program.

Each participant will be assessed pain, strength, gait biomechanics and functionality before and after 16 sessions of intervention. Pain and functionality will be further evaluated in sessions 5th and 10th. The first group will receive 16 sessions of a functional task training program and therapeutic ultrasound versus the second group who will only receive 16 sessions of the same functional task-training program.

Functional task-training program includes warm up, followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching. Therapeutic ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes. Temporal average intensity area corresponds to 0.44 W/cm2, the treatment area will be equal to 2 times the effective radiating area on the anterior, medial and lateral hip area.

The hypothesis of this study is the functional-task training program combined with therapeutic ultrasound will decrease the pain, improve the muscle hip strength the gait biomechanics and the functionality of the people with hip osteoarthritis.

In the statistical analysis of the results, the differences will be assessed in the three pain and functionality assessments with a repeated measures using ANOVA; the differences between initial and final measurement of strength, biomechanical gait variables and functionality will be evaluated with a paired Student t-test and Wilcoxon. The differences between groups will be assessed with a t-test for independent samples. Significant differences in the outcomes will be adjusted for covariates with binomial regressions, considering a significance level of p \<0.05.

For patient registries:

The Mederi Hospital has an integrated system for collecting, storing, monitoring, reviewing, and reporting on registry data of the participants of the study. It also has a Manual documentation of procedures for each registry, includes protocols and data collection instrument. The manual explains how the investigators should create or assign the patient identification numbers and how duplicate records should be prevented and how to report adverse events.

The hospital takes plans for monitoring or auditing the screening practices trough the auditing department and training to educate data collectors.

Additionally, the investigators will make a Pilot Testing to assess understanding, acceptance and feasibility the patient registry processes.

In the other hand, all staffs involved in data collection will be identified, and their roles and job will be described in data collection and processing.

All data collection will be registered in the integrated system of the Mederi Hospital. The gait biomechanics data will be recorded first in the database of the Smart DX100 system of the Laboratory of Biomechanics if the University of Rosario. The investigators will have an external research (Fulbright Scholar) that will audit the register of the biomechanics data. Then, every participant of the study will have an electronic medical record (EMR) of health-related information.

The Mederi Hospital has a system security plan that includes the policies, standard operating procedures, administrative procedures, electronic signatures and it also has a technical security support.

The plan for missing data where variables are reported as missing,unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results the investigators will quantify the extent of missingness, identifying which individuals have missing data and at which assessment then, the investigators will treat the missing data across a statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hip osteoarthritis

Exclusion Criteria:

* Musculoskeletal disability in other lower extremity joints or trunk
* Acute injuries of lower extremity and trunk in past three months
* Arthroscopic surgery
* An intra-articular injection in past three months
* Candidate for surgery
* Patients with fibromyalgia
* Patients with neurologic disease
* Participation in a structured physical activity program in past three months

Primary outcomes:
measure: Visual Analog Scale for pain
timeFrame: within the first 2 weeks before the intervention
measure: Change from Baseline Visual Analog Scale for pain at 16th session of intervention
timeFrame: within the first 2 weeks after the intervention
measure: Muscle strength
timeFrame: within the first 2 weeks before the intervention
measure: Change from Baseline Muscle strength at 16th session of intervention
timeFrame: within the first 2 weeks after the intervention
measure: Gait biomechanics
timeFrame: within the first 2 weeks before the intervention
measure: Change from Baseline Gait biomechanics at 16th session of intervention
timeFrame: within the first 2 weeks after the intervention
measure: Six minute walk test (To measure the physical function in terms of the basic mobility)
timeFrame: within the first 2 weeks before the intervention
measure: Change from Baseline Six minute walk test at 16th session of intervention
timeFrame: within the first 2 weeks after the intervention
Secondary outcomes:
measure: Change from Baseline Visual Analog Scale for pain at 5th session of intervention
timeFrame: After finishing the 5th session of intervention
measure: Change from Baseline Visual Analog Scale for pain at 10th session of intervention
timeFrame: After finishing the 10th session of intervention
measure: Change from Baseline Six minute walk test at 5th session of intervention
timeFrame: After finishing the 5th session of intervention
measure: Change from Baseline Six minute walk test at 10th session of intervention
timeFrame: After finishing the 10th session of intervention
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad del Rosario
Study officials:
affiliation: Director, Biomechanics/Sports Medicine Lab, Department of Kinesiology, Recreation, & Sport Studies College of Education, Health and Human Sciences. The University of Tennessee
name: Songning Zhang, PhD
role: STUDY_DIRECTOR
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