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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT005819 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to explore a new approach in assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy - True Acupuncture | Active Comparator | Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7.This group received true acupuncture treatment (the needles punctured the skin). |
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| Healthy - Sham Acupuncture | Sham Comparator | Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
|
| Healthy - No Treatment | No Intervention | Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | |
| Pain - True Acupuncture | Active Comparator | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
|
| Pain - Sham Acupuncture | Sham Comparator | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Subjects receive 6 acupuncture treatments for neck or back pain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule. | Start of Week 1 |
| Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject. | End of Week 2 |
| Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject. | End of Week 4 |
| Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule. | Start of Week 1 |
| Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy Chen, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Center for Translational Pain Research | Boston | Massachusetts | 02114 | United States |
254 participants were enrolled in the study and were randomly assigned to one of the 6 study arms at "Visit 1". 6 participants were later found to be ineligible to continue to participate (e.g. drug screen, medical history, no longer interested) further in "Visit 1" and they did not recieve study intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy - True Acupuncture | Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
| FG001 | Healthy - Sham Acupuncture | Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| FG002 | Healthy - No Treatment | Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
| FG003 | Pain - True Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
| FG004 | Pain - Sham Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| FG005 | Pain - No Treatment | Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy - True Acupuncture | Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
| BG001 | Healthy - Sham Acupuncture |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Heat Pain Tolerance - Baseline: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule. | Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis. | Posted | Mean | Standard Deviation | Degrees Celcius | Start of Week 1 |
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Adverse event data was collected throughout the 4 week period that a subject was participating in the study from enrollment to completion/termination of study activities.
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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 | Healthy - True Acupuncture | Healthy volunteers with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Feeling of heaviness and muscle spasm at site of acupuncture | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucy Chen | Massachusetts General Hospital | 6177246102 | mghpainresearch@partners.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Pain - No Treatment | No Intervention | Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
| Sham Acupuncture | Other | Subjects receive 6 sham acupuncture treatments for neck or back pain. |
|
Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject. |
| End of Week 2 |
| Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject. | End of Week 4 |
| Lost to Follow-up |
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| Positive Drug Screen |
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| Sensory Deficit at Site of QST |
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| Unable to Complete Questionnaires |
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| Healthy Subject Had Pain |
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| Hypertension |
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| Wrong Pain Condition |
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| Recent Interventional Injection |
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| Low Visual Analog Scale (VAS) Score |
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| Noncompliance With Study Schedule |
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Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| BG002 | Healthy - No Treatment | Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
| BG003 | Pain - True Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
| BG004 | Pain - Sham Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| BG005 | Pain - No Treatment | Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
| BG006 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Healthy - Sham Acupuncture | Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| OG002 | Healthy - No Treatment | Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
| OG003 | Pain - True Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). |
| OG004 | Pain - Sham Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). |
| OG005 | Pain - No Treatment | Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. |
|
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| Primary | Heat Pain Tolerance - Visit 2 or 4: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject. | Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis. | Posted | Mean | Standard Deviation | Degrees Celcius | End of Week 2 |
|
|
|
| Primary | Heat Pain Tolerance - Visit 3 or 7: Maximum Temperature (Heat) That Could be Tolerated by Participants | Changes in response to heat stimulation stated as tolerance to heat. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject. | Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis. | Posted | Mean | Standard Deviation | Degrees Celcius | End of Week 4 |
|
|
|
| Primary | Cold Pain Tolerance - Baseline: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken before the course of a 4 week acupuncture treatment schedule. | Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis. | Posted | Mean | Standard Deviation | Degrees Celcius | Start of Week 1 |
|
|
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| Primary | Cold Pain Tolerance - Visit 2 or 4: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken during the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 2nd visit, which occured on the same timeline as if they were attending the 4th visit as a treatment group subject. | Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis. | Posted | Mean | Standard Deviation | Degrees Celcius | End of Week 2 |
|
|
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| Primary | Cold Pain Tolerance - Visit 3 or 7: Maximum Temperature (Cold) That Could be Tolerated by Participants | Changes in response to cold stimulation stated as tolerance to cold. Responses are measured with a quantitative sensory testing (QST) device. Measurements were taken after the course of a 4 week acupuncture treatment schedule. Those in the no treatment groups were attending their 3rd visit, which occured on the same timeline as if they were attending the 7th visit as a treatment group subject. | Primary analysis was performed using the mITT (Modified Intent to Treat) method. Participants who were assigned a group and received their 1st study intervention were included in the analysis. | Posted | Mean | Standard Deviation | Degrees Celcius | End of Week 4 |
|
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| 0 |
| 39 |
| 1 |
| 39 |
| EG001 | Healthy - Sham Acupuncture | Healthy with no neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). | 0 | 39 | 0 | 39 |
| EG002 | Healthy - No Treatment | Healthy volunteers with no neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | 0 | 34 | 0 | 34 |
| EG003 | Pain - True Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received true acupuncture treatment (the needles punctured the skin). | 0 | 56 | 0 | 56 |
| EG004 | Pain - Sham Acupuncture | Volunteers with radiating neck or back pain who attended 7 visits over 4 weeks and received 6 30 minute acupuncture treatment sessions during visits 2-7. This group received sham acupuncture treatment (the needles did not puncture the skin). | 0 | 42 | 0 | 42 |
| EG005 | Pain - No Treatment | Volunteers with radiating neck or back pain who attended 3 visits over 4 weeks and received no sham or true acupuncture treatment. | 0 | 38 | 0 | 38 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |