Knee OsteoarthritisNCT04628013
Influence of Noxious Electrical Stimulation on Chronic Pain From Knee Osteoarthritis
A study testing Noxious Electrical Stimulation (NxES) in people with Knee Osteoarthritis, run by University of New England at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Noxious Electrical Stimulation (NxES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 31 Dec 2022
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Noxious Electrical Stimulation on Chronic Pain
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.
Read more
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.
Read the detailed description
Up to forty-four participants (22 for Aim 1; 22 for Aim 2) with knee OA will be recruited using advertisements, the Legacy Scholars research registry maintained by UNE's Center of Excellence in Aging and Health, from participants with knee OA previously involved in the investigator's research who indicated their willingness to participate in other studies, and from a local orthopedic surgeon group practice. Potential participants will complete a per-participation survey online or by phone that will be used to determine eligibility based on inclusion/exclusion criteria.
For Aims 1 and 2, eligible individuals will be asked to defer any plan for knee joint injections until after the testing period. Participants will be asked to refrain from taking any pain medications for at least 4 hours prior to testing. After giving informed consent, individuals who have diabetes will undergo sensory testing to confirm that their sensory detection threshold is no lower than the mean (+ 2 standard deviations) of the detection threshold of healthy older adults which is 1.4 g of force applied by a size 4.17 monofilament. This threshold is based on data collected in our laboratory using the 4-2-1- method of steps. If the individual is unable to perceive 1.4 g stimulus s/he will not continue in the study.
Protocol for Aim 1- Data collected for Aim 1 will occur over 4 sessions. The purpose of this aim is to determine the magnitude and duration of the day-to-day effects on clinical pain relief and quantitative sensory tests related to pain after a single NxES treatment.
Session 1: In this session we will gain informed consent, then perform a sensory screen (if necessary), collect demographic data and baseline questionnaire data and familiarize participants with the quantitative sensory testing (QST) procedures and to briefly experience the NxES treatment.
Session 2: During this session, participants will experience a single treatment with NxES and we will assess changes in pain and function and QST measures before and after the treatment. For the NxES Intervention, a pair of 2x3 inch electrodes will be placed on the medial and lateral sides of the knee. Pulses of electrical current (400 µs biphasic square wave pulses delivered at 50-100 pulses/second; 10-seconds on: 10-seconds off) will be applied for 20 minutes. The amplitude of the current will be increased until the participant rates the pain 50/100 on numeric pain rating scale. Pain intensity and unpleasantness will be assessed every two-min. and amplitude will be increased to maintain the 5/10 pain intensity level during the treatment. QST will be performed immediately after the treatment and 1 hour later. One- to two-minute washout periods will be provided between QST test repetitions and a 20-minute washout period will be provided after the NxES treatment and the post-treatment test of conditioned pain modulation.
Sessions 3-4: These sessions will occur 24-hours and 72-hours after session 2 and pain and function along with QST will be performed.
Protocol for Aim 2- The purpose of this aim is to determine if there is a cumulative response to NxES treatment on clinical pain and quantitative sensory tests related to pain. Data collected for Aim 2 will begin at least 1-week after the testing for Aim 1 and take place over a 2-week treatment period. Follow-up testing will take place 72-hours and 4-weeks after the last NxES treatment session.
Session 1: This session will be used to re-collect baseline questionnaire data and re-familiarize participants with procedures if it has been greater than 2-weeks since participation in Aim 1 or if they declined participation in Aim 1.
Session 2: During this session, participants will receive the first NxES treatment and undergo assessment of QST, pain, and function.
Session 3-7: These sessions are NxES treatment sessions. Pain and QST assessment will be collected at the beginning of sessions 3,5 \& 7 only.
Session 8: No treatments will be performed; post-treatment assessments will occur at 72 hours after session 7.
Session 9: No treatments will be performed; post-treatment assessments will be completed 4 weeks after session 7.
Sessions 2-7 must be completed within 18 calendar days in order to preserve the fidelity of the intervention dosage.
- Conditions
- Knee Osteoarthritis
- Being tested
- Noxious Electrical Stimulation (NxES)
- Keywords
- electrical stimulation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Noxious Electrical Stimulation (NxES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
CPM is a test of central pain inhibition. CPM is the difference in PPT measured before and after a painful "conditioning stimulus" is applied. The conditioning stimulus will be immersion of the non-dominant hand in a cold water bath (6-8°C) for 2-minutes. The PPTs will be measured at the wrist of the dominant arm and at the knee at 30- and 90-seconds of immersion. The change in the values from baseline across time points will be analyzed.
Measured: 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)
HTS is a test of central pain facilitation. It will be completed using a computer-controlled thermode (TSA-II, Medoc, Israel). First, the thermode applies temperature that increases at a rate of 8°C/second until the participant rates thermal pain to be 20-30/100 on the VAS and that temperature (TVAS30) is recorded. Next, the thermode will deliver 10 heat pulses (at a magnitude that will elicit a VAS pain rating of 30/100) once every 2.5 seconds. Participant will provide a VAS after each pulse and difference between the highest and first VAS will be used in the analysis. The change in the values from baseline across time points will be analyzed.
Measured: 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)
PPT at the proximal dorsal wrist 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.
Measured: 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
With arms crossed over their chests, participants will rise from a chair and returned to the seated position as quickly as possible for five repetitions and time will be measured in seconds to complete the test. The change in the values from baseline across time points will be analyzed.
Measured: 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)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-reported measure that consists of 5 sub-scales (Pain, other Symptoms, Activities of Daily Living, Sports/Recreation, and knee-related Quality of Life). Each sub-scale score is reported on a 0-100 scale, where a 0 indicates extreme symptoms and 100 indicates no symptoms. The change in the values from baseline across time points will be analyzed.
Measured: Aim 1: Assessed at baseline only. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start2 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott K Stackhouse, PT, PhD, Principal investigator, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628013
- Sponsor's protocol ID
- 052820-16
- Status last verified
- Aug 2023
- First submitted
- 23 Oct 2020
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 26247163Eckenrode 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.
PubMed 26075151Eckenrode BJ, Kietrys DM, Stackhouse SK. PAIN SENSITIVITY IN CHRONIC ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Dec;14(6):945-956.
PubMed 31803527Defrin 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.
PubMed 15836978
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Noxious Electrical Stimulation on Chronic Pain
- ClinicalTrials.gov ID
- NCT04628013
- Acronym / sponsor ID
- 052820-16
- Conditions
- Knee Osteoarthritis
- Keywords
- electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of New EnglandUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Nov 2020 (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.
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.
Detailed description
Up to forty-four participants (22 for Aim 1; 22 for Aim 2) with knee OA will be recruited using advertisements, the Legacy Scholars research registry maintained by UNE's Center of Excellence in Aging and Health, from participants with knee OA previously involved in the investigator's research who indicated their willingness to participate in other studies, and from a local orthopedic surgeon group practice. Potential participants will complete a per-participation survey online or by phone that will be used to determine eligibility based on inclusion/exclusion criteria.
For Aims 1 and 2, eligible individuals will be asked to defer any plan for knee joint injections until after the testing period. Participants will be asked to refrain from taking any pain medications for at least 4 hours prior to testing. After giving informed consent, individuals who have diabetes will undergo sensory testing to confirm that their sensory detection threshold is no lower than the mean (+ 2 standard deviations) of the detection threshold of healthy older adults which is 1.4 g of force applied by a size 4.17 monofilament. This threshold is based on data collected in our laboratory using the 4-2-1- method of steps. If the individual is unable to perceive 1.4 g stimulus s/he will not continue in the study.
Protocol for Aim 1- Data collected for Aim 1 will occur over 4 sessions. The purpose of this aim is to determine the magnitude and duration of the day-to-day effects on clinical pain relief and quantitative sensory tests related to pain after a single NxES treatment.
Session 1: In this session we will gain informed consent, then perform a sensory screen (if necessary), collect demographic data and baseline questionnaire data and familiarize participants with the quantitative sensory testing (QST) procedures and to briefly experience the NxES treatment.
Session 2: During this session, participants will experience a single treatment with NxES and we will assess changes in pain and function and QST measures before and after the treatment. For the NxES Intervention, a pair of 2x3 inch electrodes will be placed on the medial and lateral sides of the knee. Pulses of electrical current (400 µs biphasic square wave pulses delivered at 50-100 pulses/second; 10-seconds on: 10-seconds off) will be applied for 20 minutes. The amplitude of the current will be increased until the participant rates the pain 50/100 on numeric pain rating scale. Pain intensity and unpleasantness will be assessed every two-min. and amplitude will be increased to maintain the 5/10 pain intensity level during the treatment. QST will be performed immediately after the treatment and 1 hour later. One- to two-minute washout periods will be provided between QST test repetitions and a 20-minute washout period will be provided after the NxES treatment and the post-treatment test of conditioned pain modulation.
Sessions 3-4: These sessions will occur 24-hours and 72-hours after session 2 and pain and function along with QST will be performed.
Protocol for Aim 2- The purpose of this aim is to determine if there is a cumulative response to NxES treatment on clinical pain and quantitative sensory tests related to pain. Data collected for Aim 2 will begin at least 1-week after the testing for Aim 1 and take place over a 2-week treatment period. Follow-up testing will take place 72-hours and 4-weeks after the last NxES treatment session.
Session 1: This session will be used to re-collect baseline questionnaire data and re-familiarize participants with procedures if it has been greater than 2-weeks since participation in Aim 1 or if they declined participation in Aim 1.
Session 2: During this session, participants will receive the first NxES treatment and undergo assessment of QST, pain, and function.
Session 3-7: These sessions are NxES treatment sessions. Pain and QST assessment will be collected at the beginning of sessions 3,5 \& 7 only.
Session 8: No treatments will be performed; post-treatment assessments will occur at 72 hours after session 7.
Session 9: No treatments will be performed; post-treatment assessments will be completed 4 weeks after session 7.
Sessions 2-7 must be completed within 18 calendar days in order to preserve the fidelity of the intervention dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Noxious Electrical Stimulation (NxES) | Experimental | Device: Noxious Electrical Stimulation (NxES)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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Noxious Electrical Stimulation (NxES)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. | Device | Noxious Electrical Stimulation (NxES) |
Primary outcome
Change in Pain Pressure Threshold (PPT medial tibial plateau)
Time frame: 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.
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.
Change in Brief Pain Inventory (BPI)
Time frame: 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.
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.
Change in Movement-Related Pain
Time frame: 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.
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.
Change in Intermittent and Constant Osteoarthritis Pain scale (ICOAP)
Time frame: Aim 1: Assessed at baseline only. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.
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.
5 secondary outcomes
Change in Conditioned Pain Modulation (CPM)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Aim 1: Assessed at baseline only. Aim 2: Assessed at baseline, at 72-hours after final intervention, and 4-weeks post-intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 26247163Stackhouse 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.
- Background: PubMed 26075151Eckenrode 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.
- Background: PubMed 31803527Eckenrode BJ, Kietrys DM, Stackhouse SK. PAIN SENSITIVITY IN CHRONIC ACHILLES TENDINOPATHY. Int J Sports Phys Ther. 2019 Dec;14(6):945-956.
- Background: PubMed 15836978Defrin 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.
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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.
Scott K Stackhouse, PT, PhD principal investigator
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noxious Electrical Stimulation (NxES) in people with Knee Osteoarthritis, run by University of New England at 1 site in United States.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 21 Aug 2023. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Pressure Threshold (PPT medial tibial plateau) (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628013, which also lists 4 linked publications.
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 21 Aug 2023.