## Protocol Section
### Identification Module
**NCT ID:** NCT00976079

**Brief Title:** The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait

**Official Title:** The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait

#### Organization Study ID Info
**ID:** 13360
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
### Status Module
#### Completion Date
**Date:** 2009-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2009-09-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-09-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-05

**Type:** ACTUAL

#### Start Date
**Date:** 2007-11

**Status Verified Date:** 2009-09

#### Study First Post Date
**Date:** 2009-09-14
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-11
**Study First Submit QC Date:** 2009-09-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Virginia

#### Responsible Party

**Old Name Title:** Christopher D. Ingersoll, PhD

**Old Organization:** University of Virginia

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and a control group. Assignment of conditions will be concealed. All participants in each of the three groups will receive physical therapy for all 4 weeks of the intervention. Main outcome measures will include quadriceps central activation ratio, quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as knee joint kinetics and kinematics during gait. The purpose of this study is to to determine if the continuous use of TENS therapy for activities of daily living and rehabilitation will positively impact all outcome measures.

### Conditions Module

**Conditions:**

- Tibial Femoral Knee Osteoarthritis

- Osteoarthritis

**Keywords:**

- Tibial femoral knee osteoarthritis

- Osteoarthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 49

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Active TENS therapy for 4 weeks plus standard physical therapy for same time period.

**Intervention Names:**

- Device: Transcutaneous electrical nerve stimulation (TENS)

**Label:** Active TENS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Placebo TENS for 4 weeks plus standard physical therapy for same time period.

**Intervention Names:**

- Device: Placebo TENS

**Label:** Placebo TENS

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** No TENS, standard physical therapy for 4 weeks.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active TENS

**Description:** Continuous TENS use

**Name:** Transcutaneous electrical nerve stimulation (TENS)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Placebo TENS

**Description:** Placebo TENS use

**Name:** Placebo TENS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Quadriceps central activation ratio

**Time Frame:** 2 and 4 weeks

**Measure:** Quadriceps torque production

**Time Frame:** 2 and 4 weeks

#### Secondary Outcomes

**Measure:** WOMAC score

**Time Frame:** 2 and 4 weeks

**Measure:** Visual analog pain score

**Time Frame:** 2 and 4 weeks

**Measure:** Knee joint kinetics and kinematics

**Time Frame:** 2 and 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients who have been diagnosed with a Kellgren and Lawrence grade of 1- 4 for Tibial Femoral Knee OA in at least one leg or have been diagnosed with OA by a physician using evidence confirmed from imaging studies, arthroscopy, or visualization during an past surgical procedures, or have medical reports confirming OA using imaging studies, arthroscopy, or visualization during an past surgical procedures.
* Patients between the ages of 18 and 80 years of age.
* Patients will have a CAR less than 90%.

Exclusion Criteria:

* Patients who are pregnant.
* Patients who have sought medical attention for a trauma to the knee injury within the past 6 months.
* Patients who have had any orthopaedic lower extremity surgery in the past 6 months, or any surgery that would inhibition proper functioning of the study methodology.
* Patients with a diagnosis of Rheumatoid Arthritis.
* Patients with a known hypersensitivity to electrical stimulation.
* Patients with any types of neuropathy.
* Patients with known muscular abnormalities.
* Patients with a history of a heart condition that precludes them from exercise.
* The technique can not be performed on the leg that has had a total knee replacement, but if the other leg meets the inclusion criteria the subject can perform the study on the non- reconstructed leg.
* Patients diagnosed with malignancy over the stimulating electrode site (thigh and knee).
* Patients with serious infection near the stimulating electrode sites (thigh and knee)
* Patients have not had a knee injection in the past 2 weeks.
* Patients who are unable to walk a series of 30 meters without a walking assistance device.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia

**State:** Virginia

**Zip:** 22908

#### Overall Officials

**Official 1:**

**Affiliation:** University of Virginia

**Name:** Christopher Ingersoll, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Misc Info Module

- Version Holder: 2024-05-24
