Influence of Noxious Electrical Stimulation on Chronic Pain From Knee Osteoarthritis

NCT04628013 | Completed FDA Device

• 1 other identifier: 052820-16
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (OA) is the most common lower extremity joint pain condition, and it is estimated that 15 million people in the US are living with symptomatic knee OA and that more than half (8 million) are under 65 years of age. To that end, the Centers for Disease Control and Prevention strongly recommends non-pharmacological treatments for chronic pain including physical therapy and weight loss; however, these interventions have significant barriers that can prevent their success. An intervention that targets pain specifically is transcutaneous electrical nerve stimulation (TENS), which is a low-cost intervention with evidence to support pain reduction. As used in the majority of research to date, the intervention called "TENS" refers to the application of electricity across the skin that produces a tingling sensation that is strong but comfortable. However, electricity is applied at a noxious level is thought to result in strong activation of the endogenous pain modulation system, thus producing longer-lasting pain inhibition. However, noxious electrical stimulation (NxES) has rarely been investigated as a treatment intervention. Recent studies, including our own, demonstrate that NxES produces immediate and potentially greater pain relief. Despite some promising research, the clinical use of NxES is sparse and more research is necessary to demonstrate its effects on resting pain, movement-related pain, physical function, and quality of life. The investigators hypothesize that the application of NxES will activate pain modulation mechanisms and change the pain modulation profile toward an anti-nociceptive state in adults with chronic knee osteoarthritis (OA) pain, and thereby decrease pain (at rest and with movement), improve physical function, and improve quality of life. The investigators expect individual differences; therefore, participants will be classified at baseline and their response to the intervention tracked using psychophysical tests and clinical response. The hypothesis will be tested through 2 Specific Aims. Aim 1: The investigators will test the magnitude and duration of pain relief and functional improvement of a single treatment with NxES in adults with chronic knee OA pain. Aim 2: The investigators will determine if repeated NxES treatments show greater pain relief and/or functional improvements and if so, whether the gains plateau after a certain number of treatments. The knowledge gained by this study will be important to physical therapists and other health care practitioners who treat people with chronic knee osteoarthritic pain. If noxious electrical stimulation is found to be an effective strategy to decrease pain at rest and with movement, it may lead to improved patient care, improved function, and decreased chronic pain in people with knee osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

electrical stimulation

Outcome Measures

Primary Outcomes (4)

• Change in Pain Pressure Threshold (PPT medial tibial plateau)

  PPT will be measured using a pressure algometer (Wagner Instruments, USA; 1cm-squared rubber tip). Pressure will be applied and participants will indicate when the pressure turns to pain. Two trials from each test site with be averaged and used in the analysis. The change in the values from baseline across time points will be analyzed.

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Brief Pain Inventory (BPI)

  The Brief Pain Inventory (BPI) is a 15-question pain questionnaire that examines pain intensity and interference of pain on general activity, mood, walking, work, relationships, sleep and enjoyment of life. The pain intensity sub-scale is score from 0 to 40 points with higher values indicating greater pain intensity. The pain interference sub-scale is scored from 0 to 70 points with higher values indicating greater pain interference. The change in the values from baseline across time points will be analyzed.

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Movement-Related Pain

  Movement-Related Pain will be assessed with a scale on which participants mark their pain intensity on a 100-mm line with 0= "no knee pain" and 100="worst knee pain imaginable". The pain rating will be used to assess pain during functional testing with the 5-times Sit-to-Stand (5xSTS) and the time taken to complete the test will also be recorded and analyzed. The change in the values from baseline across time points will be analyzed.

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Intermittent and Constant Osteoarthritis Pain scale (ICOAP)

  The Intermittent and Constant Osteoarthritis Pain scale (ICOAP) scale is an 11-item questionnaire; participants rate their constant and intermittent pain on a 5-point scale based on their pain over the past week. The lowest possible score is 0 and the highest score is 100; greater values indicate increasing amounts of pain. The change in the values from baseline across time points will be analyzed.

  Aim 1: Assessed at baseline only. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

Secondary Outcomes (5)

• Change in Conditioned Pain Modulation (CPM)

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Heat Temporal Summation (HTS)

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Pressure Pain Threshold (PPT wrist)

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Five-Times Sit-to-Stand (5xSTS) Test

  Aim 1: Assessed at baseline, immediately post-treatment, 24- and 72-hours post-treatment. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

• Change in Knee injury and Osteoarthritis Outcome score (KOOS)

  Aim 1: Assessed at baseline only. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.

Other Outcomes (4)

• Pain Catastrophizing Scale (PCS)

  Aim 1: Baseline only Aim 2: Baseline only

• Pain Sensitivity Questionnaire (PSQ)

  Aim 1: Baseline only Aim 2: Baseline only

• Brief Resiliency Scale (BRS)

  Aim 1: Baseline only Aim 2: Baseline only

Study Arms (1)

Noxious Electrical Stimulation (NxES)

EXPERIMENTAL

The NxES intervention will be applied for a single treatment in Aim 1 and after a washout period, will be applied 3x/week for 2-weeks (6 sessions) for Aim 2.

Device: Noxious Electrical Stimulation (NxES)

Interventions

Noxious Electrical Stimulation (NxES) DEVICE

The NxES intervention will be applied with a pair of 2x3 inch electrodes placed orthogonally to the knee joint line with one electrode on the medial and lateral sides of the knee. The device is a commercially available unit(Chattanooga Continuum, DJO Global, Vista CA) and the parameters of the NxES include: 400 μs biphasic square wave pulses delivered at 50-100 pulses/second, using a cycle time of 10-seconds on, with a 2-second ramp-up in intensity, followed by a 10-second off period. The current intensity will be dosed over the first 2-minutes of stimulation to find the sensory perception threshold and the threshold for the first perception of a sharp, prickly buzzing sensation that they would identify as painful. Next, the current intensity will gradually be increased until the participant reports a sharp or prickly buzzing sensation that achieves a pain rating of not more than a 5/10 using a numeric pain rating scale.

Noxious Electrical Stimulation (NxES)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• follow instructions given in English
• have chronic knee joint-related pain of at least 6-months duration with a pain rating of at least 30/100 mm (0 = no knee pain, 100 = worst imaginable knee pain) over the last 24-hrs.
• report knee pain of at least 30/100 mm with walking, during sit-to-stand transfers, or during stair use

You may not qualify if:

• prior experience with NxES
• knee joint injections in the last 3-months or during the time of study participation
• history of total knee arthroplasty in the involved knee
• history of other surgery during the previous 6-months
• history of fibromyalgia or other chronic pain condition
• history of rheumatoid arthritis or related condition
• history of neurologic disorders
• history of cardiovascular or pulmonary disorders that would prevent the completion of the sit-to-stand test
• physician-diagnosed Raynaud's Syndrome
• history of diabetes with diminished sensation
• history of dementia/cognitive impairment

Sponsors & Collaborators

• University of New England: lead

Study Sites (1)

University of New England

Portland, Maine, 04103, United States

Location

Related Publications (4)

• Stackhouse SK, Taylor CM, Eckenrode BJ, Stuck E, Davey H. Effects of Noxious Electrical Stimulation and Eccentric Exercise on Pain Sensitivity in Asymptomatic Individuals. PM R. 2016 May;8(5):415-24. doi: 10.1016/j.pmrj.2015.07.009. Epub 2015 Aug 3.

  PMID: 26247163 BACKGROUND

• Eckenrode BJ, Stackhouse SK. IMPROVED PRESSURE PAIN THRESHOLDS AND FUNCTION FOLLOWING NOXIOUS ELECTRICAL STIMULATION ON A RUNNER WITH CHRONIC ACHILLES TENDINOPATHY: A CASE REPORT. Int J Sports Phys Ther. 2015 Jun;10(3):354-62.

  PMID: 26075151 BACKGROUND

• Eckenrode BJ, Kietrys DM, Stackhouse SK. PAIN SENSITIVITY IN CHRONIC ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Dec;14(6):945-956.

  PMID: 31803527 BACKGROUND

• Defrin R, Ariel E, Peretz C. Segmental noxious versus innocuous electrical stimulation for chronic pain relief and the effect of fading sensation during treatment. Pain. 2005 May;115(1-2):152-60. doi: 10.1016/j.pain.2005.02.018.

  PMID: 15836978 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Scott K Stackhouse, PT, PhD

  University of New England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators propose a single arm/pre-post trial to examine the effects of NxES on resting pain (BPI, ICOAP), pain sensitivity (PPT, HTS, CPM), movement-related pain (5xSTS), and physical function (5xSTS, KOOS) for people with knee OA. The investigators plan to examine the potential time-course effects after a single intervention (immediate, 1-hr, 24-, and 72-hours) and due to repeated treatment (3x/week for 2-weeks) at the end of treatment (post 72-hours and 4-weeks).

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 13, 2020
• Study Start: August 2, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)