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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AT005819-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized clinical trial to compare the clinical effectiveness of radicular pain relief by either acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative Sensory Testing (QST).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True Acupuncture | Active Comparator | Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. |
|
| Sham Acupuncture | Sham Comparator | Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments. |
|
| Gabapentin | Active Comparator | Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. |
|
| Sham Gabapentin | Sham Comparator | Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | In true acupuncture the needles penetrate the skin. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain) | Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant. | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. |
| Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation) | Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant. | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianren Mao, M.D., Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Center for Translational Pain Research | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34325532 | Derived | Chen L, Deng H, Houle T, Zhang Y, Ahmed S, Zhang W, Sullivan S, Opalacz A, Roth S, Filatava EJ, Stabach K, Vo T, Malarick C, Kim H, You Z, Shen S, Mao J. Comparison between acupuncture therapy and gabapentin for chronic pain: a pilot study. Acupunct Med. 2021 Dec;39(6):619-628. doi: 10.1177/09645284211026683. Epub 2021 Jul 29. |
| Label | URL |
|---|---|
| Center for Translational Pain Research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | True Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. Acupuncture: In true acupuncture the needles penetrate the skin. |
| FG001 | Sham Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments. Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin. |
| FG002 | Gabapentin | Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain. |
| FG003 | Sham Gabapentin | Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | True Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. Acupuncture: In true acupuncture the needles penetrate the skin. |
| BG001 | Sham 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 | Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 for CS, WS, HP, CP (CS: Cold Sensation; WS: Warm Sensation; HP: Heat Pain; CP: Cold Pain) | Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant. | Enrolled participants who didn't withdraw, were not withdrawn by the investigator. | Posted | Mean | Standard Deviation | degree celsius | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. |
|
The PI will monitor study outcomes. A monthly study staff meeting will be held to review the study progress and discuss any adverse event during study conduction. Adverse event were monitored through study completion, an average of 3 months.
Adverse events will be reported to the PHRC in accordance with the PHRC unanticipated problems including adverse events guidelines. <http://healthcare.partners.org/phsirb/adverse\_events.htm\>.
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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 | True Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. Acupuncture: In true acupuncture the needles penetrate the skin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject participated in a session of sham acupuncture. When the needles, tape, small plastic rings were removed, the acupuncturist noticed redness on the subject's back around the site of the rings. The subject felt no discomfort, itchiness, or pain. |
A major limitation is the limited number of study participants in each group. In addition, the use of a sham needle in this pilot study may not have fully differentiated sham versus true electroacupuncture. While the use of diphenhydramine as a placebo control for gabapentin may have mimicked certain side effects of gabapentin, it may have had other confounding effects on the data interpretation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucy Chen | Massachusetts General Hospital | 617-724-6102 | mghpainresearch@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2015 | Dec 11, 2023 | Prot_SAP_000.pdf |
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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 |
| D000077206 | Gabapentin |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Sham Acupuncture |
| Other |
In sham acupuncture the needles do not penetrate the skin. |
|
| Gabapentin | Drug | Gabapentin is a commonly prescribed drug used to treat neuropathic pain. |
|
|
| Sham Gabapentin | Drug | Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness) |
|
|
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin.
| BG002 | Gabapentin | Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain. |
| BG003 | Sham Gabapentin | Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| OG000 | True Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. Acupuncture: In true acupuncture the needles penetrate the skin. |
| OG001 | Sham Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments. Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin. |
| OG002 | Gabapentin | Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain. |
| OG003 | Sham Gabapentin | Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness) |
|
|
| Primary | Changes in QST Measures in Response to Acupuncture or Gabapentin at Visit 1, Visit 4 and Visit 7 HPT, CPT and Tol (HPT: Heat Pain Threshold; CPT: Cold Pain Threshold; Tol: Tolerance to 47°C Heat Stimulation) | Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupuncture treatment and throughout the gabapentin medication regimen. Measurements are taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups or within treatment week 3 for medication groups), up to a maximum of 3 weeks for each participant. | Enrolled participants who didn't withdraw, were not withdrawn by the investigator. | Posted | Mean | Standard Deviation | Seconds | 3 weeks apart. Taken at Visit 1 (before any intervention), Visit 4 (after session 3 for acupuncture groups or within treatment week 2 for medication groups), and Visit 7 (after session 6 for acupuncture groups. |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sham Acupuncture | Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments. Sham Acupuncture: In sham acupuncture the needles do not penetrate the skin. | 0 | 16 | 0 | 16 | 1 | 16 |
| EG002 | Gabapentin | Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Gabapentin: Gabapentin is a commonly prescribed drug used to treat neuropathic pain. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG003 | Sham Gabapentin | Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks. Sham Gabapentin: Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness) | 0 | 14 | 0 | 14 | 0 | 14 |
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D005680 |
| gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| visit 1 cold pain threshold |
|
| Visit 1 tolerance to 47 celsius heat simulation |
|
| visit 4 heat pain threshold |
|
| visit 4 cold pain threshold |
|
| Visit 4 tolerance to 47 celsius heat simulation |
|
| visit 7 heat pain threshold |
|
| visit 7 cold pain threshold |
|
| Visit 7 tolerance to 47 celsius heat simulation |
|