Back to resultsNeuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound therapy
neuromuscular electrical stimulation application
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee osteoarthritis, neuromuscular electrical stimulation, ultrasound therapy
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of knee osteoarthritis
- Exclusion Criteria:
Cardiovascular diseases
Inflammatory diseases
Infectious diseases
Lower extremity weakness
Tumoral diseases
Knee surgery in the past six months
Intra-articular injection in the past six months
Sites / Locations
- Gul Devrimsel
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 patients
Group 2 patients
Arm Description
Patients have grade 2 or 3 knee osteoarthritis ultrasound therapy
Patients have grade 2 or 3 knee osteoarthritis neuromuscular electrical stimulation application
Outcomes
Primary Outcome Measures
Visual analog scale
Pain was assessed using a 0 to 10 visual analogue pain scale, with 0 meaning 'no pain' and 10 meaning 'excruciating pain'.
Western Ontario and McMaster Universities Arthritis Index
The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters.To assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis, Minimum total score: 0, maximum total score: 96.Disability scores increase as Womac osteoarthritis index scores increase.
15 meter walking test
The patients were asked to walk as fast as possible along a level, unobstructed corridor on the command "go." The patients stood before the starting line. A hand-held stopwatch was started as the subjects passed a predetermined start mark and stopped as they passed a second mark 15meter from the start mark.Walking duration was determined as second before and after treatment
Muscle measurements were made before and after treatment.
Ultrasonography was used to measure muscle thickness, pennation angle and fascicle length. Muscle thickness was measured as the mean distance between the superficial and deep aponeurosis at both image muscles. The distance between the intersection composed of the superficial aponeurosis and muscle fascicle, and the intersection composed of the deep aponeurosis and muscle fascicle was defined as muscle fascicle length. The results was measured as millimeter.The angle between the muscle fascicle and deep aponeurosis was defined as Pennation angle.
Secondary Outcome Measures
Full Information
NCT ID
NCT03727256
First Posted
October 22, 2018
Last Updated
October 30, 2018
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03727256
Brief Title
Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis
Official Title
Recep Tayyip Erdogan University Medical School
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
October 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To determine the effects of ultrasound therapy and neuromuscular electrical stimulation on the muscle architecture and functional capacity of patients with knee osteoarthritis.
Detailed Description
All participants who were satisfied with the inclusion criteria were randomly assigned to one of two study groups: Group 1- ultrasound therapy group; Group 2 - the neuromuscular electrical stimulation group. Group allocation was randomized in two blocks of 30 sealed envelopes without external marks, which were mixed and numbered from 1 to 30, containing a piece of paper with the group allocation. The researchers responsible for outcome measures and ultrasonograhic measurements were blinded to the patients' diagnosis or intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee osteoarthritis, neuromuscular electrical stimulation, ultrasound therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 patients
Arm Type
Active Comparator
Arm Description
Patients have grade 2 or 3 knee osteoarthritis ultrasound therapy
Arm Title
Group 2 patients
Arm Type
Active Comparator
Arm Description
Patients have grade 2 or 3 knee osteoarthritis neuromuscular electrical stimulation application
Intervention Type
Other
Intervention Name(s)
ultrasound therapy
Intervention Description
Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes
Intervention Type
Other
Intervention Name(s)
neuromuscular electrical stimulation application
Intervention Description
Group 2, neuromuscular electrical stimulation application;20 mins/session
Primary Outcome Measure Information:
Title
Visual analog scale
Description
Pain was assessed using a 0 to 10 visual analogue pain scale, with 0 meaning 'no pain' and 10 meaning 'excruciating pain'.
Time Frame
3 weeks
Title
Western Ontario and McMaster Universities Arthritis Index
Description
The WOMAC (Westren Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee using 24 parameters.To assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis, Minimum total score: 0, maximum total score: 96.Disability scores increase as Womac osteoarthritis index scores increase.
Time Frame
3 weeks
Title
15 meter walking test
Description
The patients were asked to walk as fast as possible along a level, unobstructed corridor on the command "go." The patients stood before the starting line. A hand-held stopwatch was started as the subjects passed a predetermined start mark and stopped as they passed a second mark 15meter from the start mark.Walking duration was determined as second before and after treatment
Time Frame
3 weeks
Title
Muscle measurements were made before and after treatment.
Description
Ultrasonography was used to measure muscle thickness, pennation angle and fascicle length. Muscle thickness was measured as the mean distance between the superficial and deep aponeurosis at both image muscles. The distance between the intersection composed of the superficial aponeurosis and muscle fascicle, and the intersection composed of the deep aponeurosis and muscle fascicle was defined as muscle fascicle length. The results was measured as millimeter.The angle between the muscle fascicle and deep aponeurosis was defined as Pennation angle.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of knee osteoarthritis
Exclusion Criteria:
Cardiovascular diseases
Inflammatory diseases
Infectious diseases
Lower extremity weakness
Tumoral diseases
Knee surgery in the past six months
Intra-articular injection in the past six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUL DEVRIMSEL
Organizational Affiliation
Dr.
Official's Role
Study Director
Facility Information:
Facility Name
Gul Devrimsel
City
Rize
ZIP/Postal Code
53100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis
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