Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis

Chronic Pain Clinical Trial

Official title:

Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis (Self tDCS and Knee Pain)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425019
• Other study ID #: HSC-SN-17-1072
• Status: Completed
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: October 5, 2018

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• have self-reported unilateral or bilateral knee OA pain, according to American College of Rheumatology criteria

• have had knee OA pain in the past 3 months with an average of at least 3 on a 10 cm Visual Analog Scale (VAS) for pain

• can speak and read English

• have a device with internet access that can be used for secure video conferencing for real-time remote supervision

• have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit

• have no plan to change medication regimens for pain throughout the trial

• are able to travel to the coordinating center

• are willing and able to provide written informed consent prior to enrollment.

Exclusion Criteria:

• previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee

• history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation

• systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia

• uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure = 150/95 mm Hg)

• heart failure

• history of acute myocardial infarction

• peripheral neuropathy

• alcohol/substance abuse

• cognitive impairment (i.e., Mini-Mental Status Exam score = 23)

• pregnancy or lactation

• hospitalization within the preceding year for psychiatric illness

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Soterix 1x1 tDCS mini-CT Stimulator device
Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ahn H, Sorkpor S, Miao H, Zhong C, Jorge R, Park L, Abdi S, Cho RY. Home-based self-administered transcranial direct current stimulation in older adults with knee osteoarthritis pain: An open-label study. J Clin Neurosci. 2019 Aug;66:61-65. doi: 10.1016/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)	Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).	baseline
Primary	Clinical Pain Intensity as Assessed by a Visual Analogue Scale (VAS)	Scores on the visual analogue scale (VAS) range from 0 (no pain) to 100 (worst pain imaginable).	2 weeks
Secondary	Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale	The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.	baseline
Secondary	Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Pain Subscale	The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.	2 weeks
Secondary	Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale	The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.	baseline
Secondary	Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Stiffness Subscale	The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.	2 weeks
Secondary	Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale	The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.	baseline
Secondary	Clinical Pain Intensity as Assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Functional Impairment Subscale	The WOMAC is a self-administered questionnaire consisting of 3 subscales related to pain (pain subscale total score range, 0-20), stiffness (stiffness subscale total score range, 0-8), and impairments of physical function (functional impairment subscale range, 0-68), with higher scores indicating worse pain, stiffness, and impairments of physical function, respectively.	2 weeks
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Summary Scale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.	baseline
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Continuous Pain Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The continuous pain subscale assesses throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender, and total score on the continuous pain subscale ranges from 0-60, with a higher score indicating worse pain.	2 weeks
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.	baseline
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Intermittent Pain Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The intermittent pain subscale assesses shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing, and total score on the intermittent pain subscale ranges from 0-60, with a higher score indicating worse pain.	2 weeks
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.	baseline
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Neuropathic Pain Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The neuropathic pain subscale assesses hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or 'pins and needles', and numbness, and total score on the neuropathic pain subscale ranges from 0-60, with a higher score indicating worse pain.	2 weeks
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.	baseline
Secondary	Clinical Pain Intensity as Assessed by Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) - Affective Description Subscale	The SF-MPQ-2 measures the quality as well as the intensity of pain. Participants complete the SF-MPQ-2 by rating the extent to which they experienced each of 22 pain descriptors in the past week using an 11-point numeric rating scale (0 = "none" to 10 = "worst possible"). The affective description subscale assesses tiring-exhausting, sickening, fearful, and punishing-cruel, and total score on the affective description subscale ranges from 0-40, with a higher score indicating worse pain.	2 weeks
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful" is reported.	baseline
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Threshold (HPTH)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess HPTH, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when the sensation ''first becomes painful" to assess the heat pain threshold (HPTH). The temperature at which participants pressed the button to indicate the sensation ''first becomes painful" is reported.	2 weeks
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain." The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain" is reported.	baseline
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Heat Pain Tolerance (HPTO)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess HPTO, heat stimuli were delivered to the participant's arm or knee using a computer-controlled TSAII NeuroSensory Analyzer. From a baseline of 32 degrees Celsius, the temperature increased by 0.5 degrees Celsius per second until the participants responded by pressing a button to stop heat stimuli. Participants were instructed to press the button when they ''no longer feel able to tolerate the pain." The temperature at which participants pressed the button to indicate they could ''no longer feel able to tolerate the pain" is reported.	2 weeks
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.	baseline
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Pressure Pain Threshold (PPT)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's medial knee, lateral knee, or trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.	2 weeks
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).	baseline
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Punctate Mechanical Pain (PMP)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; To assess PMP, punctate mechanical pain is delivered to the patella or hand by a calibrated nylon monofilament for 10 contacts of the monofilament at one contact per second. Participants rate the pain intensity on a scale from 0 (no pain) to 100 (maximum imaginable pain).	2 weeks
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.	baseline
Secondary	Experimental Pain Sensitivity as Assessed by a Multimodal Quantitative Sensory Testing (QST) Battery - Conditioned Pain Modulation (CPM)	In order to measure experimental pain sensitivity, a multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain threshold (HPTH); heat pain tolerance (HPTO), pressure pain threshold (PPT), punctate mechanical pain (PMP), and Conditioned Pain Modulation (CPM).; CPM is reported as the change in PPT before and immediately following immersion of the contralateral hand up to the wrist in a cold water bath (12 degrees Celsius) for up to one minute. To assess PPT, a handheld digital pressure algometer (Wagner, Greenwich, CT) was applied at a constant rate of 0.3 kilograms force per centimeter squared (kgf/cm^2) per second to the participant's trapezius. Participants were asked to notify the experimenter when the pressure sensation ''first becomes painful." The pressure at which participants pressed the button to indicate that the pressure sensation ''first becomes painful" is reported.	2 weeks
Secondary	Number of Participants Who Were Assessed by Functional Near-infrared Spectroscopy (fNIRS)	Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.	2 weeks
Secondary	Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Using Device	Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q1) "Overall the device was easy to use"	2 weeks
Secondary	Feasibility as Assessed by a Survey of Participants' tDCS Experience - Ease of Preparation of Device	Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q2) "It was easy to prepare the device and accessories"	2 weeks
Secondary	Feasibility as Assessed by a Survey of Participants' tDCS Experience - Effectiveness of Treatment Over Time	Data will be collected on participants' tDCS experience at the conclusion of tDCS treatment on a scale of 0 (strongly disagree) to 10 (strongly agree): Q3) "The effectiveness of the treatment increased over the course of treatment."	2 weeks
Secondary	Tolerability as Assessed by Number of Participants With Side Effects	The participants will be asked in an open-ended manner whether they have experienced any side effects, and they will then be asked specifically about tingling, itching sensation, burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty concentrating, mood change, and changes in vision or visual perception.	2 weeks
Secondary	Anxiety as Assessed by the PROMIS Anxiety-short Form	The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.	baseline
Secondary	Anxiety as Assessed by the PROMIS Anxiety-short Form	The 7-item PROMIS anxiety-short form assesses the pure domain of anxiety in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.	2 weeks
Secondary	Depression as Assessed by the PROMIS Depression-short Form	The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.	baseline
Secondary	Depression as Assessed by the PROMIS Depression-short Form	The 8-item PROMIS depression-short form assesses the pure domain of depression in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.	2 weeks
Secondary	Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form	The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	baseline
Secondary	Sleep Disturbance as Assessed by the PROMIS Sleep Disturbance-short Form	The 8-item PROMIS sleep disturbance-short form assesses the pure domain of sleep disturbance in individuals age 18 and older, and each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	2 weeks