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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AT004497-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
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In this proposal, we plan to dynamically investigate brain response to verum acupuncture (of two different "doses") and placebo acupuncture, using a paradigm that approximates clinical acupuncture practice across multiple treatment sessions in knee osteoarthritis (OA) patients. This proposal aims to: 1) characterize session-to-session brain responses to verum / sham acupuncture treatment (reliability of response) for OA patients, and 2) investigate how different "doses" of acupuncture influence brain response and acupuncture efficacy (impact of dose). The findings of this project will deepen our biological understanding on why and how acupuncture can treat chronic pain and what happens in the brain during the multiple-session acupuncture treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose acupuncture | Experimental | six needle applied during acupuncture |
|
| Low dose acupuncture | Experimental | two needles will be applied. |
|
| placebo acupuncture | Placebo Comparator | sham acupuncture treatment will be applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | patient will receive high dose, low dose or sham acupuncture treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment | The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain. | One post-treatment measurement 5-7 weeks after baseline |
| Cortical Thickness Changes at 5-7 Weeks Post-Treatment | All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software. | 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Kong | Massachusetts General Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hosptial | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26511911 | Derived | Chen X, Spaeth RB, Freeman SG, Scarborough DM, Hashmi JA, Wey HY, Egorova N, Vangel M, Mao J, Wasan AD, Edwards RR, Gollub RL, Kong J. The modulation effect of longitudinal acupuncture on resting state functional connectivity in knee osteoarthritis patients. Mol Pain. 2015 Oct 29;11:67. doi: 10.1186/s12990-015-0071-9. | |
| 25258037 | Derived | Chen X, Spaeth RB, Retzepi K, Ott D, Kong J. Acupuncture modulates cortical thickness and functional connectivity in knee osteoarthritis patients. Sci Rep. 2014 Sep 26;4:6482. doi: 10.1038/srep06482. |
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Fourteen subjects did not complete the study due to problems with scheduling (6), ineligibility at screening (3), disinterest (2), claustrophobia (1), or inability to adhere to study requirements in scanner (2). Of the 14 subjects who dropped, four dropped out after randomization.
Forty-four acupuncture naïve patients aged 43-70 with a diagnosis of chronic osteoarthritis in the right and/or left knee participated in the study. 30 (13 females) completed all study procedures. Fourteen subjects did not complete the study. All subjects were recruited form the Boston area over the course of the past 3 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Acupuncture | six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
| FG001 | Low Dose Acupuncture | two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
| FG002 | Placebo Acupuncture | sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Acupuncture | six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
| BG001 | Low Dose Acupuncture |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Knee Injury and Osteoarthritis Outcome Score (KOOS Pain Rating) at 5-7 Weeks Post-Treatment | The Knee injury and Osteoarthritis Outcome Score (KOOS) was used to measure clinical outcomes. KOOS is measured on a scale from 0-4 with 0 being no pain and 4 being extreme pain (the worst). The KOOS is comprised of 5 subscales, each of which produces an outcome score. These subscales include pain, other symptoms, function in daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL). Based on previous studies, subscale scores of the KOOS related to pain, function in daily living, and function in sport and recreation were selected as the primary outcome of the present study. For each subscale, a normalized score was calculated, where 0 indicated the most extreme symptoms/pain and 100 indicated no symptoms/pain. | Posted | Mean | Standard Deviation | units on KOOS scale | One post-treatment measurement 5-7 weeks after 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 | High Dose Acupuncture | six needle applied during acupuncture acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
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Limitations of the study are the small sample size as well as the effects of factors such as age, gender, and chronic duration of pain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jian Kong | Mass General Hospital | 617-726-7893 | kongj@nmr.mgh.harvard.edu |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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two needles will be applied.
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.
| BG002 | Placebo Acupuncture | sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
six needle applied during acupuncture
acupuncture : patient will receive high dose, low dose or sham acupuncture treatment.
| OG001 | Low Dose Acupuncture | two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
| OG002 | Placebo Acupuncture | sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. |
|
|
| Primary | Cortical Thickness Changes at 5-7 Weeks Post-Treatment | All eligible patients were scanned using fMRI while receiving treatment during acupuncture sessions 1, 3, and 6. Structural MRI data were only compared between Session 1 (pre-treatment) and Session 6 (post-treatment). The structural data was analyzed using FreeSurfer software. | We combined low and high dose acupuncture into one group because we found there were not clinical differences between the two group. | Posted | Mean | Standard Deviation | millimeters | 2 days; one at baseline and another post-treatment measurement taken 5-7 weeks after baseline |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Low Dose Acupuncture | two needles will be applied. acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. | 0 | 15 | 0 | 15 |
| EG002 | Placebo Acupuncture | sham acupuncture treatment will be applied acupuncture : patient will receive high dose, low dose or sham acupuncture treatment. | 0 | 14 | 0 | 14 |
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