Back to resultsThe Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
Primary Purpose
Knee Pain
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
electrical stimulation
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain
Eligibility Criteria
Inclusion Criteria:
- Male or Female between the ages of 45 years or older
- Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
- Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each visit
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the beginning of the study.
Exclusion Criteria:
- Pregnancy
- Diabetes Mellitus
- Neuropathy
- Smoker
- Uncontrolled HTN
- Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
- Arthritis (RA) in the area to be treated by TENS
- Allergic to tape/electrodes
- Dementia
- History of knee joint replacement or tibial osteotomy
- Undergoing physical therapy
- Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
- Contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees)
- Severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumber disc, herniation, and rheumatoid arthritis)
- The subject does not utilize stairs in daily living
- The subject is unable to walk without ambulatory assistive devices.
Sites / Locations
- Omron healthcare Co.,Ltd.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active TENS
Sham TENS
Arm Description
Outcomes
Primary Outcome Measures
stair climb test
An 11-step stairway with a step height of 17 cm will be used. Participants will begin with both feet on the bottom landing, then ascend and descend the stairway as fast as possible, and finally stop with both feet back on the bottom landing while using a handrail support, if required. Time recording will be started when the participant is signalled to start and ended when the participant returns with both feet on the ground.
timed Up and Go test (TUG)
The participant will sit down at first and then stand up when given the signal to start. As fast as possible, the participant will walk 3 meters toward a cone on the floor, circle it, walk back 3 more meters toward a chair, and finally sat down. Timing begins on the signal to start and ends when the participant completely sits down with their back resting on the backrest of the chair.
6-minute walk test (6MWT)
In the 6MWT, the participants will walk as far as they could within 6 minutes. They will not be allowed to carry a watch or provided feedback during the trial. Although rest periods are allowed, time recording will continue. The participants will be provided encouragement at 1-minute intervals.
VAS(Visual Analog Scale score) for knee pain
The mean knee pain during the stair climb test, TUG test, and 6MWT will be measured using the VAS. Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively.
The Knee injury and Osteoarthritis Outcome Score (KOOS)
The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Perceived Competence Scale (PCS) questionnaire
The Perceived Competence Scale (PCS) concerns feelings about behaving in healthy ways. This is a short 4-item questionnaire that assesses the degree to which participants feel confident about being able to make (or maintain) a change toward a healthy behavior, participate in a health-care program, or carry out a treatment regimen/physical tests.
The Hospital Anxiety and Depression Scale (HADS)
HADS was found to perform well in assessing the symptom severity of anxiety disorders and depression in in the general population. The sensitivity and specificity for both HADS-A and HADS-D of approximately 0.80. The questionnaire comprises seven questions for anxiety and seven questions for depression.
Secondary Outcome Measures
2-step test
Gait stride length is measured to assess walking ability, including muscle strength, balance, and flexibility of the lower limbs. The starting line is determined, and participants stand with the toes of both feet behind this line. They take 2 long steps (as long as possible) and then align both their feet. Subsequently, the length of the 2 steps from the starting line to the toes is measured.
stand-up test
The participant will stand up on 1 or both legs from a seat at a specified height. For this test, 4 seats are set up at different heights (40, 30, 20, and 10 cm). First, the participants will sit on the 40-cm high seat with arms folded. If they can stand up on both legs, they then attempt to stand on 1 leg. If they can stand up on both their right and left legs, they pass the height level. The participants then repeat the trial at the next seat height, and the trials will be performed in the order of descending height.
Knee extensor strength
The maximum isometric knee extensor strengths will be measured using a handheld dynamometer (HHD), which is the validated method in a previous research on elderly individuals who are prone to falls.17 The maximum force will be recorded in Newtons (N), and testing will be repeated for 2 measurements.
Full Information
NCT ID
NCT04084236
First Posted
September 6, 2019
Last Updated
March 12, 2020
Sponsor
Omron Healthcare Co., Ltd.
Collaborators
Western Michigan University
1. Study Identification
Unique Protocol Identification Number
NCT04084236
Brief Title
The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
Official Title
The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
May 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Omron Healthcare Co., Ltd.
Collaborators
Western Michigan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of TENS at the knee pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active TENS
Arm Type
Active Comparator
Arm Title
Sham TENS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
electrical stimulation
Intervention Description
electrical stimulation
Intervention Type
Device
Intervention Name(s)
Sham
Intervention Description
no stimulation
Primary Outcome Measure Information:
Title
stair climb test
Description
An 11-step stairway with a step height of 17 cm will be used. Participants will begin with both feet on the bottom landing, then ascend and descend the stairway as fast as possible, and finally stop with both feet back on the bottom landing while using a handrail support, if required. Time recording will be started when the participant is signalled to start and ended when the participant returns with both feet on the ground.
Time Frame
2 hours
Title
timed Up and Go test (TUG)
Description
The participant will sit down at first and then stand up when given the signal to start. As fast as possible, the participant will walk 3 meters toward a cone on the floor, circle it, walk back 3 more meters toward a chair, and finally sat down. Timing begins on the signal to start and ends when the participant completely sits down with their back resting on the backrest of the chair.
Time Frame
2 hours
Title
6-minute walk test (6MWT)
Description
In the 6MWT, the participants will walk as far as they could within 6 minutes. They will not be allowed to carry a watch or provided feedback during the trial. Although rest periods are allowed, time recording will continue. The participants will be provided encouragement at 1-minute intervals.
Time Frame
2 hours
Title
VAS(Visual Analog Scale score) for knee pain
Description
The mean knee pain during the stair climb test, TUG test, and 6MWT will be measured using the VAS. Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively.
Time Frame
2 hours
Title
The Knee injury and Osteoarthritis Outcome Score (KOOS)
Description
The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).
Time Frame
2 hours
Title
Perceived Competence Scale (PCS) questionnaire
Description
The Perceived Competence Scale (PCS) concerns feelings about behaving in healthy ways. This is a short 4-item questionnaire that assesses the degree to which participants feel confident about being able to make (or maintain) a change toward a healthy behavior, participate in a health-care program, or carry out a treatment regimen/physical tests.
Time Frame
2 hours
Title
The Hospital Anxiety and Depression Scale (HADS)
Description
HADS was found to perform well in assessing the symptom severity of anxiety disorders and depression in in the general population. The sensitivity and specificity for both HADS-A and HADS-D of approximately 0.80. The questionnaire comprises seven questions for anxiety and seven questions for depression.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
2-step test
Description
Gait stride length is measured to assess walking ability, including muscle strength, balance, and flexibility of the lower limbs. The starting line is determined, and participants stand with the toes of both feet behind this line. They take 2 long steps (as long as possible) and then align both their feet. Subsequently, the length of the 2 steps from the starting line to the toes is measured.
Time Frame
2 hours
Title
stand-up test
Description
The participant will stand up on 1 or both legs from a seat at a specified height. For this test, 4 seats are set up at different heights (40, 30, 20, and 10 cm). First, the participants will sit on the 40-cm high seat with arms folded. If they can stand up on both legs, they then attempt to stand on 1 leg. If they can stand up on both their right and left legs, they pass the height level. The participants then repeat the trial at the next seat height, and the trials will be performed in the order of descending height.
Time Frame
2 hours
Title
Knee extensor strength
Description
The maximum isometric knee extensor strengths will be measured using a handheld dynamometer (HHD), which is the validated method in a previous research on elderly individuals who are prone to falls.17 The maximum force will be recorded in Newtons (N), and testing will be repeated for 2 measurements.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or Female between the ages of 45 years or older
Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each visit
No phobia of electrical stimulation
No pain or anti-inflammatory medication will be taken during study
OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the beginning of the study.
Exclusion Criteria:
Pregnancy
Diabetes Mellitus
Neuropathy
Smoker
Uncontrolled HTN
Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
Arthritis (RA) in the area to be treated by TENS
Allergic to tape/electrodes
Dementia
History of knee joint replacement or tibial osteotomy
Undergoing physical therapy
Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
Contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees)
Severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumber disc, herniation, and rheumatoid arthritis)
The subject does not utilize stairs in daily living
The subject is unable to walk without ambulatory assistive devices.
Facility Information:
Facility Name
Omron healthcare Co.,Ltd.
City
Muko
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shozo Takamatsu
Phone
+81-75-925-2043
Email
shozo.takamatsu@omron.com
First Name & Middle Initial & Last Name & Degree
Keisuke Yamada
Phone
+81-75-925-2043
Email
K.Yamada@omron.com
12. IPD Sharing Statement
Learn more about this trial
The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
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