Transcranial Direct Current Stimulation in Older Persons With Knee Pain (Knee Pain and tDCS): Randomized Pilot Study

Knee Osteoarthritis Clinical Trial

Official title:

Transcranial Direct Current Stimulation in Older Persons With Knee Pain: Randomized Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512393
• Other study ID #: IRB201500357-2
• Status: Completed
• Phase: N/A
• First received: July 29, 2015
• Last updated: September 2, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to study the effects of Transcranial Direct Current Stimulation (tDCS) on clinical pain, mobility disability, and pain sensitivity to gain a better understanding of the factors that cause pain and disability in people with knee osteoarthritis (OA). In particular, people from different ethnic and racial groups may experience OA pain differently which is why the focus will be on older Asian Americans and non-Hispanic whites. It is important to find a reason for such difference so that a better treatment can be found for all OA patients. In addition, the research study will examine if there is any ethnic differences in pain and mobility disability. The investigator hypothesize that Asian Americans will report greater pain and mobility disability than non-Hispanic whites, and that active tDCS will result in improvement in pain and disability compared to sham tDCS.

Description:

If you participate in the study, the following will happen:

Randomized into one of two groups. Which will either receive the full length session of brain stimulation or a much shorter session of brain stimulation. The shorter version of stimulation looks like and is performed in the same way as the longer electrical stimulation session, but stimulation is stopped before it can have much of an effect on the brain. You will not know which group you have been assigned to while participating in the research, but you may find out at the completion of the research study.

X-Rays will be done on both knees while standing up.

Questionnaires about arthritis pain you are having, your thoughts and feelings about it, and any stress that you may have experienced.

Walking Test will be performed on a flat surface for 6 minutes at a fast pace without help from an assistive device (cane or walker) or another person.

Assessment of Physical Performance requires walking at short distance (about 13 feet), stand up from a chair 5 times without using your arms, and stand in 3 different positions while keeping your balance.

Assessment of Sensitivity to Heat. Heat pain sensitivity will be tested using a commercially available thermal sensory testing machine (Medoc, Inc.) used widely in clinical settings. This machine has a small (about 1 inch by 1 inch) square piece that is used to apply heat to the skin. Heat will be applied to the knees and arms. The amount of heat is controlled by a computer. One or more of the following types of heat stimuli will be delivered: 1) a slowly increasing heat that can be stopped by pressing a button when it becomes warm, painful, or intolerable; 2) a series of 5-10 heat pulses that are brief (less than 2 seconds in duration), and rate how painful each heat pulse feels; and 3) a few longer heat pulses (15-30 seconds) at different temperatures to rate how painful each heat pulse feels. The procedures can be stop at any time.

Assessment of Sensitivity to Pressure will be done using a handheld device with a small rubber tip to apply pressure to the knee, thigh, and shoulder.

Assessment of Sensitivity to Mechanical Stimulation will be done using a handheld probe that has a small nylon tip to tap both the knee and hand.

Blood Draw: Blood will be taken at the baseline visit and at the last visit.

Brain Stimulation: The stimulation technique called transcranial direct current stimulation (tDCS) and it involves placing two sponge-like electrodes on your head and delivering a very weak electrical current to your scalp, which is generated by a 9 volt battery.

In addition, weekly phone calls will be done for the next 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

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

• they can understand, speak and read English

• they are able to walk for 6-minutes

• they are willing to be randomized to either the intervention or control group

• they are available for five consecutive daily sessions and for a follow-up phone interview each week for three weeks post-stimulation sessions

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

• they are willing and able to provide written informed consent

Exclusion Criteria:

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

• serious medical illness, such as uncontrolled hypertension (i.e., Systolic Blood Pressure/Diastolic Blood Pressure of = 150/95), congestive heart failure, pacemaker, or history of acute myocardial infarction

• peripheral neuropathy

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

• alcohol/substance abuse

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

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

• pregnancy or lactation for females

• hospitalization within the preceding year due to psychiatric illness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Active tDCS
This group will receive tDCS with a constant current of 2 mA intensity will be applied for 20 minutes once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
• Sham tDCS
This group will receive tDCS with a constant current of 2 mA intensity will be applied for 30 seconds once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).

Other:
• X-Ray
Both groups will have x-rays done of their knees.
• Walking Test
A 6-minute walking test will be performed. The test will consist of walking on a flat, hard surface in a period of 6 minutes at a fast pace without help from an assistive device (cane or walker) or another person.
• Assessment of sensitivity to heat
Heat pain sensitivity will be tested using a commercially available thermal sensory testing machine.
• Assessment of Sensitivity to Pressure
A handheld device with a small (less than ½ inch wide) rubber tip to apply pressure to the skin.
• Assessment of Sensitivity to Mechanical Stimulation
A handheld probe that has a small nylon tip to tap skin.
• Blood Test
Blood will be used for biomarkers and hormones.
• Assessment of balance, chair stand, and gait speed
A short physical performance battery will be performed. The test will compose of the gait speed, chair stand, and balance tests.
• Assessment of conditioned pain modulation
Conditioned pain modulation will be done by using a cold pressor procedure on the skin.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH PROMIS-cognition will be compared between the two groups for a change between baseline and day 5	A score of 50 is the average and a score of 60 is better than average. A score of 40 is the worse score.	Change from baseline and day 5	No
Other	Safety questionnaire will be compared between the two groups for a change between baseline, 1, 2, 3, 4, and 5 days.	This is a questionnaire to assess the presence and severity of adverse events such as headache, tingling, itching, and fatigue, on a scale of 0 to 10, with 0 being not at all and 10 being a highest degree.	Change from baseline, 1, 2, 3, 4, and 5 days	No
Other	Coping Strategies Questionnaire-Revised will be compared between the two groups for a change between baseline and day 5	This is a questionnaire to assess pain coping strategies, such as distancing from pain, using a 7-point scale that ranges from never do that to always do that. The higher the scale the greater use.	Change from baseline and day 5	No
Other	Positive and Negative Affect Scale will be compared between the two groups for a change between baseline and day 5	This is a questionnaire using a 5-point scale that ranges from very slightly or not at all to extremely. The lower the scale the negative the affect and the higher the scare the positive the affect.	Change from baseline and day 5	No
Other	Pain Attitudes Questionnaire-Revised will be compared between the two groups for a change between baseline and day 5	This is a questionnaire to assess pain attitudes, such as stoicism, using a 5-point scale that ranges from strongly disagree to strongly agree. The higher the scale the more stoic.	Change from baseline and day 5	No
Primary	Numeric Rating Scale (NRS) for pain will be compared between the two groups for a change between baseline, 1, 2, 3, 4, and 5 days.	Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.	Change from Baseline, 1, 2, 3, 4, and 5 days	No
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale will be compared between the two groups for a change between baseline and day 5.	This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; these are then added up for a summation score. The higher the score, the worse the pain.	Change from baseline and day 5	No
Primary	Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) will be compared between the two groups for a change between baseline and day 5	This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible; these are then added up for a summation score. The higher the score the worse the pain.	Change from baseline and day 5	No
Primary	Six-minute walk test will be compared between the two groups for a change between baseline and day 5	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.	Change from baseline and day 5	No
Primary	Short Physical Performance Battery (SPPB) will be compared between the two groups for a change between baseline and day 5	This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The scores rand from 0 (worst performance) to 12 (best performance).	Change from baseline and day 5	No
Primary	WOMAC physical function subscale will be compared between the two groups for a change between baseline and day 5	This is a index to rate the activity of physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme, these are then added up for a summation score. The higher the score, the worse the disability.	Change from baseline and day 5	No
Primary	Heat pain sensitivity will be compared between the two groups for a change between baseline and day 5	Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.	Change from baseline and day 5	No
Primary	Pressure pain threshold will be compared between the two groups for a change between baseline, 1, 2, 3, 4, and 5 days.	Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.	Change from Baseline, 1, 2, 3, 4, and 5 days	No
Primary	Punctate mechanical pain sensitivity will be compared between the two groups for a change between baseline and day 5	Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.	Change from baseline and day 5	No
Primary	Conditioned Pain Modulation (CPM) will be compared between the two groups for a change between baseline and day 5	Conditioned pain modulation will be done by using a cold pressor procedure on the skin.	Change from baseline and day 5	No
Secondary	Composite measure of Blood Chemistries will be compared for differences between the groups for a change between baseline and day 5		Change from baseline and day 5	No