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

NCT ID: NCT02512393

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-08-31

Brief 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.

Detailed 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active tDCS

This group will receive five daily sessions of 2mA, 20 minutes of Transcranial Direct Current Stimulation (tDCS). 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). In addition, the following test will performed: X-Rays, Walking Test, Assessment of Physical Performance, Assessment of Sensitivity to Heat, Assessment of Sensitivity to Pressure, Assessment of Sensitivity to Mechanical Stimulation, Assessment of balance, chair stand, and gait speed, Assessment of conditioned pain modulation, and Blood test.

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

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 five daily sessions of 2mA, current for 30 seconds tDCS. 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). In addition, the following test will performed: X-Rays, Walking Test, Assessment of Physical Performance, Assessment of Sensitivity to Heat, Assessment of Sensitivity to Pressure, Assessment of Sensitivity to Mechanical Stimulation, Assessment of balance, chair stand, Assessment of conditioned pain modulation, and gait speed and Blood test.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

Other Intervention Names

Transcranial Direct Current Stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Hyochol Ahn

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyochol Ahn, PhD, ARNP

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

References

Ahn H, Woods AJ, Kunik ME, Bhattacharjee A, Chen Z, Choi E, Fillingim RB. Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. Brain Stimul. 2017 Sep-Oct;10(5):902-909. doi: 10.1016/j.brs.2017.05.007. Epub 2017 May 19.

Reference Type: DERIVED

PMID: 28566193 (View on PubMed)

Other Identifiers

IRB201500357-2

Identifier Type: -

Identifier Source: org_study_id