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Completed

NCT Number: NCT02512393

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active tDCS

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).

Other names: Transcranial Direct Current Stimulation

Sham tDCS

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).

Primary outcomes

  1. Numeric Rating Scale (NRS) for Pain

    Time frame: baseline

    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.

  2. Numeric Rating Scale (NRS) for Pain

    Time frame: day 5

    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.

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

    Time frame: baseline

    This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.

  4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale

    Time frame: day 5

    This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.

  5. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale

    Time frame: baseline

    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. The higher the score the worse the pain.

  6. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale

    Time frame: 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. The higher the score the worse the pain.

  7. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale

    Time frame: baseline

    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. The higher the score the worse the pain.

  8. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale

    Time frame: 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. The higher the score, the worse the pain.

  9. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale

    Time frame: baseline

    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. The higher the score the worse the pain.

  10. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale

    Time frame: 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. The higher the score the worse the pain.

  11. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale

    Time frame: baseline

    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. The higher the score the worse the pain.

  12. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale

    Time frame: 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. The higher the score the worse the pain.

  13. Six-minute Walk Test

    Time frame: baseline

    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.

  14. Six-minute Walk Test

    Time frame: 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.

  15. Short Physical Performance Battery (SPPB)

    Time frame: baseline

    This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).

  16. Short Physical Performance Battery (SPPB)

    Time frame: day 5

    This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).

  17. Heat Pain Threshold

    Time frame: baseline

    Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.

  18. Heat Pain Threshold

    Time frame: day 5

    Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.

  19. Heat Pain Tolerance

    Time frame: baseline

    Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.

  20. Heat Pain Tolerance

    Time frame: day 5

    Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.

  21. Pressure Pain Threshold

    Time frame: baseline

    Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.

  22. Pressure Pain Threshold

    Time frame: day 5

    Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.

  23. Punctate Mechanical Pain Sensitivity

    Time frame: baseline

    Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.

  24. Punctate Mechanical Pain Sensitivity

    Time frame: day 5

    Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.

  25. Conditioned Pain Modulation (CPM)

    Time frame: baseline

    Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.

  26. Conditioned Pain Modulation (CPM)

    Time frame: day 5

    Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.

Secondary outcomes

  1. Endorphin Level

    Time frame: baseline

  2. Endorphin Level

    Time frame: day 5

  3. Cortisol Level

    Time frame: baseline

  4. Cortisol Level

    Time frame: day 5

  5. C-reactive Protein (CRP) Level

    Time frame: baseline

  6. C-reactive Protein (CRP) Level

    Time frame: day 5

  7. Tumor Necrosis Factor (TNF) Level

    Time frame: baseline

  8. Tumor Necrosis Factor (TNF) Level

    Time frame: day 5

  9. Interleukin 6 (IL-6) Level

    Time frame: baseline

  10. Interleukin 6 (IL-6) Level

    Time frame: day 5

  11. Interleukin 10 (IL-10) Level

    Time frame: baseline

  12. Interleukin 10 (IL-10) Level

    Time frame: day 5

Other outcomes

  1. NIH PROMIS-cognition Will be Compared Between the Two Groups for a Change Between Baseline and Day 5

    Time frame: Change from 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.

  2. Safety Questionnaire Will be Compared Between the Two Groups for a Change Between Baseline, 1, 2, 3, 4, and 5 Days.

    Time frame: Change from 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.

  3. Coping Strategies Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5

    Time frame: Change from 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.

  4. Positive and Negative Affect Scale Will be Compared Between the Two Groups for a Change Between Baseline and Day 5

    Time frame: Change from 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.

  5. Pain Attitudes Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5

    Time frame: Change from 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • University of Florida

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2015
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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