The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain

NCT04084236 | Unknown FDA Device

• 1 other identifier: HDV-CDD-180139
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of TENS at the knee pain.

Conditions

Knee Pain

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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).

  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.

  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.

  2 hours

Secondary Outcomes (3)

• 2-step test

  2 hours

• stand-up test

  2 hours

• Knee extensor strength

  2 hours

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

Device: electrical stimulation

Sham TENS

SHAM COMPARATOR

Device: Sham

Interventions

electrical stimulation DEVICE

electrical stimulation

Active TENS

Sham DEVICE

no stimulation

Sham TENS

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Omron Healthcare Co., Ltd.: lead
• Western Michigan University: collaborator

Study Sites (1)

Omron healthcare Co.,Ltd.

Mukō, Japan

RECRUITING

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: July 15, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

JP (1)