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185 veterans with chronic knee pain and advanced knee osteoarthritis will be recruited to participate in this study designed to test the effectiveness of a special type of electrical acupuncture called periosteal stimulation (PST). Participants will be divided into three groups. They will receive PST or a control condition once a week for 10 weeks. Two-thirds of the participants will receive booster sessions periodically over the course of the next 6 months. Everyone will be called monthly during the 6 month period and then will be asked to return for an evaluation on site at the end of this period.
We have performed a promising initial trial of periosteal stimulation (PST, that is, electrical stimulation of 4 acupuncture needles around the knee that touch periosteum) as an analgesic for older veterans with advanced knee osteoarthritis (OA) and daily pain. The primary aim of the proposed trial is to optimize and sustain the efficacy of PST for reducing pain in veterans with advanced knee OA and unrelieved pain by combining it with booster PST. Our secondary aims are to 1) improve physical performance in these individuals, and 2) ascertain the physical and psychological predictors of response to PST. In a randomized controlled clinical trial, 180 veterans (age 50 and older) with persistent knee pain who have x-ray evidence of advanced OA will be assigned to one of three intervention groups: 1) control PST once a week for 10 weeks (i.e., needle placement with brief stimulation of non-periosteal needles), 2) PST once a week for 10 weeks followed by tapering PST boosters over 6 months, or 3) PST once a week for 10 weeks followed by tapering control-PST boosters over 6 months. Prior to initiating the intervention, immediately after the last session, and 6 months later, the following parameters will be assessed: 1) pain severity (WOMAC), 3) physical performance (gait velocity, stair climb, repetitive chair rise, timed up and go), and 4) psychological function (mood, coping, self-efficacy). Monthly telephone calls will assess pain, interim illness and physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PST + PST boosters | Experimental | PST once a week for 10 weeks, then tapering over 6 months |
|
| PST + control-PST boosters | Active Comparator | PST once a week for 10 weeks, then control-PST tapering over 6 months |
|
| Control-PST | Placebo Comparator | control-PST for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periosteal stimulation | Other | Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (WOMAC) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome) | 9 months following baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra K. Weiner, MD | Geriatric Research, Education, and Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric Research, Education, and Clinical Center | Pittsburgh | Pennsylvania | 15206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24184053 | Result | Weiner DK, Moore CG, Morone NE, Lee ES, Kent Kwoh C. Efficacy of periosteal stimulation for chronic pain associated with advanced knee osteoarthritis: a randomized, controlled clinical trial. Clin Ther. 2013 Nov;35(11):1703-20.e5. doi: 10.1016/j.clinthera.2013.09.025. Epub 2013 Nov 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | PST once a week for 10 weeks, then tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. |
| FG001 | Arm 2 | PST once a week for 10 weeks, then control-PST tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
| FG002 | Arm 3 | control-PST for 10 weeks Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Community dwelling adults with advanced knee osteoarthritis and chronic pain
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | PST once a week for 10 weeks, then tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain (WOMAC) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome) | Posted | Mean | Standard Error | units on a scale | 9 months following baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | PST once a week for 10 weeks, then tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | The participant completed participation in the trial. This participant was scheduled to undergo a one year follow-up questionnaire in 6-11 and died 3-11-11. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Debra K. Weiner | VA Pittsburgh Healthcare System | 412-360-2920 | debra.weiner@va.gov |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Control-Periosteal Stimulation | Other | Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
|
| Withdrawal by Subject |
|
| BG001 |
| Arm 2 |
PST once a week for 10 weeks, then control-PST tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
| BG002 | Arm 3 | control-PST for 10 weeks Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| WOMAC | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of 24 items divided into 3 subscales: Pain (5 items), score range 0-20 Stiffness (2 items): score range 0-8 Physical Function (17 items): score range 0-68 Total score ranges from 0 (best possible outcome) to 96 (worst possible outcome) | Mean | Standard Deviation | units on a scale |
|
| Short Physical Performance Battery | The SPPB measures performance on 3 items:
| Mean | Standard Deviation | units on a scale |
|
| Timed stair climb | Participants were timed as they ascended and descended 5 steps. | Mean | Standard Deviation | seconds |
|
| Timed Up and Go | The Timed Up and Go (TUG) measures mobility and falls risk. The participant sits in a chair and is timed as (s)he stands up from the chair, walks 3 meters, turns around, walks back to the chair and sits down. The result is expressed in seconds. An older adult who takes at least 12 seconds to complete the TUG is at high risk for falling. | Mean | Standard Deviation | seconds |
|
| CES-D | The Center for Epidemiological Studies-Depression (CES-D) scale is a measure of depressive symptoms. It is a 20 item. Each item is scored from 0 (rarely or none of the time) to 3 (most or all of the time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| Cognitive Strategies Questionnaire, catastrophizing scale | The catastrophizing scale of the Cognitive Strategies Questionnaire consists of 6 items, each scored from 0 (never state that) to 6 (always state that). The scoring range on the instrument is 0 (best pain coping) to 36 (worst pain coping). | Mean | Standard Deviation | units on a scale |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Mean number of pain medications | Mean number of pain medications per day | Mean | Standard Deviation | medication |
|
| Mean number of opioids | Mean number of opioids per day | Mean | Standard Deviation | opioids |
|
| Duration of knee pain | Mean | Standard Deviation | years |
|
| Arthritis Self-Efficacy score, pain | This is the pain subscale of The Arthritis Self-Efficacy Scale (ASES). The ASES consists of 20 questions divided into three subscales: physical function (9 questions), other symptoms (6 questions) and pain (5 questions). Participants are asked about their level of certainty that they can perform each task. Each question is scored from 10 = very uncertain to 100 = very certain. Each subscale is scored separately by taking the mean score of the items. Higher scores indicate higher self-efficacy. The range for the pain subscale is 10 to 100. | Mean | Standard Deviation | units on a scale |
|
| Arthritis Self-Efficacy score, function | This is the physical function subscale of The Arthritis Self-Efficacy Scale (ASES). The ASES consists of 20 questions divided into three subscales: physical function (9 questions), other symptoms (6 questions) and pain (5 questions). Participants are asked about their level of certainty that they can perform each task. Each question is scored from 10 = very uncertain to 100 = very certain. Each subscale is scored separately by taking the mean score of the items. Higher scores indicate higher self-efficacy. The range for the physical function subscale is 10 to 100. | Mean | Standard Deviation | units on a scale |
|
| Arthritis Self-Efficacy score, other symptoms | This is the other symptoms subscale of The Arthritis Self-Efficacy Scale (ASES). The ASES consists of 20 questions divided into three subscales: physical function (9 questions), other symptoms (6 questions) and pain (5 questions). Participants are asked about their level of certainty that they can perform each task. Each question is scored from 10 = very uncertain to 100 = very certain. Each subscale is scored separately by taking the mean score of the items. Higher scores indicate higher self-efficacy. The range for the other symptoms subscale is 10 to 100. | Mean | Standard Deviation | units on a scale |
|
PST once a week for 10 weeks, then control-PST tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
| OG002 | Arm 3 | control-PST for 10 weeks Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. |
|
|
| 3 |
| 63 |
| 3 |
| 63 |
| EG001 | Arm 2 | PST once a week for 10 weeks, then control-PST tapering over 6 months Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute. Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. | 1 | 64 | 0 | 64 |
| EG002 | Arm 3 | control-PST for 10 weeks Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute. | 1 | 63 | 1 | 63 |
|
| Bowel obstruction | Gastrointestinal disorders |
|
| Myocardial Infarction | Cardiac disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| abscess | Infections and infestations |
|
| Bruising | Skin and subcutaneous tissue disorders |
|
| sweating | General disorders |
|
| Lightheaded | General disorders |
|
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| D012216 |
| Rheumatic Diseases |