Knee PainNCT04084236
The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
A study testing electrical stimulation in people with Knee Pain, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effect of TENS at the knee pain. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Pain
- What is being tested?
- electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 15 Jul 2019to 30 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Omron healthcare Co.,Ltd.
Mukō
Shozo Takamatsu, +81-75-925-2043, shozo.takamatsu@omron.com
Keisuke Yamada, +81-75-925-2043, K.Yamada@omron.com
About this study
The purpose of this study is to evaluate the effect of TENS at the knee pain.
- Conditions
- Knee Pain
- Being tested
- electrical stimulation, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationDevice
electrical stimulation
ShamDevice
no stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | Not described Receives: Device: electrical stimulation |
| Sham TENS | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
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).
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
Secondary outcomes (3)
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start15 Jul 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omron Healthcare Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Western Michigan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084236
- Sponsor's protocol ID
- HDV-CDD-180139
- Status last verified
- Mar 2020
- First submitted
- 6 Sep 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
- ClinicalTrials.gov ID
- NCT04084236
- Acronym / sponsor ID
- HDV-CDD-180139
- Conditions
- Knee Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Omron Healthcare Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Western Michigan University
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 May 2020 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of TENS at the knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: electrical stimulation |
| Sham TENS | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Pregnancy
- Diabetes Mellitus
- Neuropathy
- Smoker
- Uncontrolled HTN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimulationelectrical stimulation | Device | Active TENS |
| Shamno stimulation | Device | Sham TENS |
Primary outcome
stair climb test
Time frame: 2 hours
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)
Time frame: 2 hours
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)
Time frame: 2 hours
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
Time frame: 2 hours
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)
Time frame: 2 hours
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
Time frame: 2 hours
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)
Time frame: 2 hours
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.
3 secondary outcomes
2-step test
Time frame: 2 hours
stand-up test
Time frame: 2 hours
Knee extensor strength
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation in people with Knee Pain, run by Omron Healthcare Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stair climb test (time frame: 2 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.