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

NCT02512393 | Completed Results DMC

• 1 other identifier: IRB201500357-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (26)

• Numeric Rating Scale (NRS) for Pain

  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.

  baseline

• Numeric Rating Scale (NRS) for Pain

  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.

  day 5

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

  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.

  baseline

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

  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.

  day 5

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

  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.

  baseline

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

  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.

  day 5

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

  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.

  baseline

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

  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.

  day 5

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

  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.

  baseline

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

  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.

  day 5

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

  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.

  baseline

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

  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.

  day 5

• Six-minute Walk Test

  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.

  baseline

• Six-minute Walk Test

  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.

  day 5

• Short Physical Performance Battery (SPPB)

  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).

  baseline

• Short Physical Performance Battery (SPPB)

  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).

  day 5

• Heat Pain Threshold

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

  baseline

• Heat Pain Threshold

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

  day 5

• Heat Pain Tolerance

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

  baseline

• Heat Pain Tolerance

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

  day 5

• Pressure Pain Threshold

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

  baseline

• Pressure Pain Threshold

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

  day 5

• Punctate Mechanical Pain Sensitivity

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

  baseline

• Punctate Mechanical Pain Sensitivity

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

  day 5

• Conditioned Pain Modulation (CPM)

  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.

  baseline

• Conditioned Pain Modulation (CPM)

  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.

  day 5

Secondary Outcomes (12)

• Endorphin Level

  baseline

• Endorphin Level

  day 5

• Cortisol Level

  baseline

• Cortisol Level

  day 5

• C-reactive Protein (CRP) Level

  baseline

Other Outcomes (5)

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

  Change from baseline and day 5

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

  Change from baseline, 1, 2, 3, 4, and 5 days

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

  Change from baseline and day 5

Study Arms (2)

Active tDCS

EXPERIMENTAL

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.

Device: Active tDCS

Sham tDCS

SHAM COMPARATOR

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.

Device: Sham tDCS

Interventions

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).

Also known as: Transcranial Direct Current Stimulation

Active tDCS

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).

Sham tDCS

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University of Florida: collaborator

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 28566193 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Hyochol Ahn, PhD, ARNP
• Organization: The University of Texas Health Science Center at Houston

Hyochol.Ahn@uth.tmc.edu

713-500-2179

Study Officials

• Hyochol Ahn, PhD, ARNP

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 30, 2015
• Study Start: November 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Locations

US (1)